title: Randomized Phase Ib/II Study of Gemcitabine Plus Placebo or Vismodegib, a Hedgehog Pathway Inhibitor, in Patients With Metastatic Pancreatic Cancer.
abstract: OBJECTIVE
  Sonic hedgehog (SHH), an activating ligand of smoothened (SMO), is overexpressed in > 70% of pancreatic cancers (PCs). We investigated the impact of vismodegib, an SHH antagonist, plus gemcitabine (GV) or gemcitabine plus placebo (GP) in a multicenter phase Ib/randomized phase II trial and preclinical PC models.
  
  
  METHODS
  Patients with PC not amenable to curative therapy who had received no prior therapy for metastatic disease and had Karnofsky performance score ≥ 80 were enrolled. Patients were randomly assigned in a one-to-one ratio to GV or GP. The primary end point was progression-free-survival (PFS). Exploratory correlative studies included serial SHH serum levels and contrast perfusion computed tomography imaging. To further investigate putative biologic mechanisms of SMO inhibition, two autochthonous pancreatic cancer models (Kras(G12D); p16/p19(fl/fl); Pdx1-Cre and Kras(G12D); p53(R270H/wt); Pdx1-Cre) were studied.
  
  
  RESULTS
  No safety issues were identified in the phase Ib portion (n = 7), and the phase II study enrolled 106 evaluable patients (n = 53 in each arm). Median PFS was 4.0 and 2.5 months for GV and GP arms, respectively (95% CI, 2.5 to 5.3 and 1.9 to 3.8, respectively; adjusted hazard ratio, 0.81; 95% CI, 0.54 to 1.21; P = .30). Median overall survival (OS) was 6.9 and 6.1 months for GV and GP arms, respectively (95% CI, 5.8 to 8.0 and 5.0 to 8.0, respectively; adjusted hazard ratio, 1.04; 95% CI, 0.69 to 1.58; P = .84). Response rates were not significantly different. There were no significant associations between correlative markers and overall response rate, PFS, or OS. Preclinical trials revealed no significant differences with vismodegib in drug delivery, tumor growth rate, or OS in either model.
  
  
  CONCLUSIONS
  The addition of vismodegib to gemcitabine in an unselected cohort did not improve overall response rate, PFS, or OS in patients with metastatic PC. Our preclinical and clinical results revealed no statistically significant differences with respect to drug delivery or treatment efficacy using vismodegib.
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD. dcatenac@medicine.bsd.uchicago.edu.
authors.forename: Daniel V T
authors.initials: DV
authors.lastname: Catenacci
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Melissa R
authors.initials: MR
authors.lastname: Junttila
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Theodore
authors.initials: T
authors.lastname: Karrison
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Nathan
authors.initials: N
authors.lastname: Bahary
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Margit N
authors.initials: MN
authors.lastname: Horiba
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Sreenivasa R
authors.initials: SR
authors.lastname: Nattam
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Robert
authors.initials: R
authors.lastname: Marsh
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: James
authors.initials: J
authors.lastname: Wallace
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Mark
authors.initials: M
authors.lastname: Kozloff
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Lakshmi
authors.initials: L
authors.lastname: Rajdev
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Deirdre
authors.initials: D
authors.lastname: Cohen
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: James
authors.initials: J
authors.lastname: Wade
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Bethany
authors.initials: B
authors.lastname: Sleckman
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Heinz-Josef
authors.initials: HJ
authors.lastname: Lenz
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Patrick
authors.initials: P
authors.lastname: Stiff
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Pankaj
authors.initials: P
authors.lastname: Kumar
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Peng
authors.initials: P
authors.lastname: Xu
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Les
authors.initials: L
authors.lastname: Henderson
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Naoko
authors.initials: N
authors.lastname: Takebe
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Ravi
authors.initials: R
authors.lastname: Salgia
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Xi
authors.initials: X
authors.lastname: Wang
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Walter M
authors.initials: WM
authors.lastname: Stadler
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Frederic J
authors.initials: FJ
authors.lastname: de Sauvage
authors.affiliation: Daniel V.T. Catenacci, Theodore Karrison, James Wallace, Mark Kozloff, Peng Xu, Les Henderson, Ravi Salgia, Walter M. Stadler, Hedy L. Kindler, University of Chicago Medical Center; Patrick Stiff, Loyola University Medical Center, Chicago; Robert Marsh, Northshore University Health System, Evanston; James Wallace, Mark Kozloff, Ingalls Hospital, Harvey; James Wade, Decatur Memorial Hospital, Decatur; Pankaj Kumar, Oncology/Hematology Associates, Peoria, IL; Melissa R. Junttila, Xi Wang, and Frederic J. de Sauvage, Genentech, South San Francisco; Heinz-Josef Lenz, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nathan Bahary, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Margit N. Horiba, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Sreenivasa R. Nattam, Ft Wayne Medical Oncology/Hematology, Ft Wayne, IN; Lakshmi Rajdev, Montefiore Medical Center, Bronx; Deirdre Cohen, New York University Cancer Center, New York, NY; Bethany Sleckman, St John's Mercy Medical Center, St Louis, MO; and Naoko Takebe, National Cancer Institute, National Institutes of Health, Bethesda, MD.
authors.forename: Hedy L
authors.initials: HL
authors.lastname: Kindler
mesh_terms: D000328:Adult; D000368:Aged; D000813:Anilides / Q000494:pharmacology / Q000627:therapeutic use*; D000818:Animals; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D053823:Hedgehog Proteins / Q000037:antagonists & inhibitors* / Q000378:metabolism; D006801:Humans; D053208:Kaplan-Meier Estimate; D017567:Karnofsky Performance Status; D008297:Male; D051379:Mice; D008875:Middle Aged; D009367:Neoplasm Staging; D016017:Odds Ratio; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology*; D011725:Pyridines / Q000494:pharmacology / Q000627:therapeutic use*; D015398:Signal Transduction / Q000187:drug effects*; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000813:Anilides; D053823:Hedgehog Proteins; C538724:HhAntag691; D011725:Pyridines; C509239:SHH protein, human; D003841:Deoxycytidine; D000093542:Gemcitabine