Cetuximab Plus Gemcitabine in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Pancreas
RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cell from dividing so they stop growing or die. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of cetuximab plus gemcitabine in treating patients who have locally advanced, metastatic, or recurrent cancer of the pancreas.
Drug: gemcitabine hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody C225 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer|
|Study Start Date:||October 1999|
|Study Completion Date:||April 2003|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine objective response, time to progression, survival, clinical benefit response, and quality of life of patients with locally advanced, metastatic, or recurrent adenocarcinoma of the pancreas when treated with cetuximab and gemcitabine. II. Determine the safety and toxicity profile of this regimen in this patient population.
OUTLINE: This is a multicenter study. Patients receive a test dose of cetuximab IV over 10 minutes followed by a 30 minute observation period. Following observation, patients receive a loading dose of cetuximab IV over 1-2 hours followed 1 hour later by gemcitabine IV over 30 minutes weekly for 7 weeks. Following 1 week of rest, patients with stable or responding disease continue treatment for a maximum of 6 months. During subsequent courses, patients receive maintenance doses of cetuximab IV over 1 hour weekly for 8 weeks. Gemcitabine IV is administered over 30 minutes weekly for 3 weeks, followed by 1 week of rest, and then repeated for a total treatment course of 8 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline, after each course of therapy, and at 3 months after therapy. Patients are followed every 3 months until evidence of disease progression.
PROJECTED ACCRUAL: A minimum of 40 patients will be accrued for this study within 8 months.
|Study Chair:||Albert F. LoBuglio, MD||University of Alabama at Birmingham|