title: Phase II trial of induction gemcitabine/CPT-11 followed by a twice-weekly infusion of gemcitabine and concurrent external beam radiation for the treatment of locally advanced pancreatic cancer.
abstract: OBJECTIVE
  This phase II trial of induction irinotecan/gemcitabine followed by twice-weekly gemcitabine and upper abdominal radiation was initiated to determine the activity of this regimen in patients with unresectable pancreatic cancer.
  
  
  METHODS
  Patients with locally advanced, nonmetastatic adenocarcinoma of the pancreas received 2 cycles of induction irinotecan (100 mg/m2 IV) and gemcitabine (1000 mg/2 IV) on days 1 and 8 of each 3-week cycle. Following the induction, patients without disease progression received gemcitabine administered twice weekly (40 mg/m2/day) for 5 weeks concurrent with upper abdominal radiation (50.4 Gy over 5.5 weeks).
  
  
  RESULTS
  From April 2000 to August 2003, 20 patients were entered into this study, 17 of whom were evaluable for treatment response. Characteristics included a median age of 67 years (range, 44-87 years) and 14 men (70%). Grades III and IV hematologic toxicity occurred in 25% and 5% of patients respectively and was primarily thrombocytopenia. No grade IV gastrointestinal toxicities or deaths due to therapy were observed. All therapy was completed in 8 patients, 7 patients were removed due to progression, 2 due to toxicity, 2 refused further treatment, and 1 was removed per the treating physician. The median time to progression and median survival was 5.1 months (95% CI, 3.2-6.7) and 8.8 months (95% CI, 6.4-10.1) respectively. Four patients (20%) were alive at 12 and 18 months.
  
  
  CONCLUSIONS
  Induction irinotecan/gemcitabine followed by twice-weekly gemcitabine and upper abdominal radiation is feasible in patients with locally advanced pancreatic cancer. This regimen, however, has only modest activity and should not be explored further.
authors.affiliation: Division of Gastroenterology, Comprehensive Cancer Center, Wake Forest University, Winston-Salem, North Carolina 27516, USA.
authors.forename: Girish
authors.initials: G
authors.lastname: Mishra
authors.forename: Jerome
authors.initials: J
authors.lastname: Butler
authors.forename: Coty
authors.initials: C
authors.lastname: Ho
authors.forename: Susan
authors.initials: S
authors.lastname: Melin
authors.forename: L Douglas
authors.initials: LD
authors.lastname: Case
authors.forename: Peter R
authors.initials: PR
authors.lastname: Ennever
authors.forename: Gustav C
authors.initials: GC
authors.lastname: Magrinat
authors.forename: James D
authors.initials: JD
authors.lastname: Bearden
authors.forename: Drew C
authors.initials: DC
authors.lastname: Minotto
authors.forename: Russell
authors.initials: R
authors.lastname: Howerton
authors.forename: Edward
authors.initials: E
authors.lastname: Levine
authors.forename: A William
authors.initials: AW
authors.lastname: Blackstock
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D018714:Radiotherapy, Adjuvant; D015996:Survival Rate; D013921:Thrombocytopenia / Q000139:chemically induced; D014839:Vomiting / Q000139:chemically induced; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000077146:Irinotecan; D002166:Camptothecin; D000093542:Gemcitabine