title: Phase II study of docetaxel and gefitinib as second-line therapy in gemcitabine pretreated patients with advanced pancreatic cancer.
abstract: BACKGROUND
  There is no standard second-line therapy for advanced pancreatic cancer (APC). We evaluated the epidermal growth factor receptor (EGFR) inhibitor gefitinib and docetaxel in a phase II study following gemcitabine failure.
  
  
  METHODS
  EGFR overexpression was not required. The initial docetaxel dose was 75 mg/m(2) on day 1 every 21 days. Due to febrile neutropenia in 8 of the first 18 patients, the dose was reduced to 60 mg/m(2). Gefitinib, 250 mg/day orally, was given continuously.
  
  
  RESULTS
  Forty-one patients received treatment and were evaluable. Febrile neutropenia was seen in 11 patients (27%), with most events occurring at the docetaxel dose of 75 mg/m(2) (8 of 18 patients). Common treatment-related grade 3/4 toxicities were: fatigue (7%), nausea (7%), diarrhea (5%) and vomiting (2%). There was 1 partial response and stable disease in 19 patients. Time to progression was 1.8 months and median survival was 4.5 months (95% CI 2.9-5.7).
  
  
  CONCLUSIONS
  The tolerability and feasibility of second-line therapy for APC was demonstrated. The combination of gefitinib and docetaxel showed evidence of limited efficacy.
authors.affiliation: University Hospitals Case Medical Center, Ireland Cancer Center, Cleveland, Ohio, USA.
authors.forename: Joanna M
authors.initials: JM
authors.lastname: Brell
authors.forename: Khalid
authors.initials: K
authors.lastname: Matin
authors.forename: Terry
authors.initials: T
authors.lastname: Evans
authors.forename: Robert L
authors.initials: RL
authors.lastname: Volkin
authors.forename: Gauri J
authors.initials: GJ
authors.lastname: Kiefer
authors.forename: James J
authors.initials: JJ
authors.lastname: Schlesselman
authors.forename: Shelley
authors.initials: S
authors.lastname: Dranko
authors.forename: Linda
authors.initials: L
authors.lastname: Rath
authors.forename: Amy
authors.initials: A
authors.lastname: Schmotzer
authors.forename: Diana
authors.initials: D
authors.lastname: Lenzner
authors.forename: Ramesh K
authors.initials: RK
authors.lastname: Ramanathan
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D000093542:Gemcitabine
chemical_list: D011799:Quinazolines; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000077156:Gefitinib; D000093542:Gemcitabine