Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Biological therapies such as erlotinib use different ways to
      stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and
      biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more
      effective with or without erlotinib in treating pancreatic cancer.

      PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and
      without erlotinib in treating patients who have unresectable locally advanced or metastatic
      pancreatic cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the overall survival rate in patients with unresectable locally advanced or
           metastatic pancreatic cancer treated with gemcitabine with or without erlotinib.

        -  Compare the progression-free survival rate in patients treated with these regimens.

        -  Compare the quality of life of patients treated with these regimens.

        -  Compare the response rate and response duration in patients treated with these regimens.

        -  Compare the nature, severity, and frequency of toxic effects of these regimens in these
           patients.

        -  Correlate the expression of tissue epidermal growth factor receptor levels at diagnosis
           with outcome and response in patients treated with these regimens.

        -  Determine the pharmacokinetics of erlotinib in these patients.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to participating center, extent of disease (locally advanced vs
      metastatic), and ECOG performance status (0-1 vs 2). Patients are randomized to one of two
      treatment arms.

        -  Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and
           43 of course 1 only, which lasts 8 weeks, and on days 1, 8, and 15 of all subsequent
           courses, which last 4 weeks each. Patients also receive 1 of 2 doses of oral erlotinib
           once daily.

        -  Arm II: Patients receive gemcitabine as in arm I and 1 of 2 doses of oral placebo once
           daily.

      Treatment continues in both arms in the absence of disease progression or unacceptable
      toxicity.

      Quality of life is assessed at baseline, on day 29 of course 1, on day 1 of all subsequent
      courses, at 4 weeks after study, and then every 12 weeks until disease progression.

      Patients are followed at 4 weeks and then every 12 weeks thereafter.

      PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this
      study within 11 months.
    

Intervention name(s): erlotinib hydrochloride; gemcitabine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg po daily; 1000 mg/m2 IV weekly (Cycle 1 -Day 1, 8, 15, 22, 29, 36, 43 of an 8 week cycle, Cycle 2 and subsequent cycles -Day 1,8 and 15 of a 4 week cycle)
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: stage III pancreatic cancer; adenocarcinoma of the pancreas; stage IV pancreatic cancer