Bevacizumab and Gemcitabine Combined With Either Cetuximab or Erlotinib in Treating Patients With Advanced Pancreatic Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00091026
Phase
PHASE2
Status
Completed

Conditions

  • Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage II Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with advanced pancreatic cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining bevacizumab and gemcitabine with either cetuximab or erlotinib may kill more tumor cells.

Key Dates

First listed
Sep 8, 2004
Start date
Jul 31, 2004
Status verified
Dec 2012
Primary completion
Jan 31, 2011
Completion
Jan 31, 2011

Study Design

Enrollment
143 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (cetuximab, gemcitabine hydrochloride, bevacizumab)
    Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
  • Experimental: Arm II (gemcitabine hydrochloride, bevacizumab, erlotinib)
    Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.

Primary Outcome Measure

Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637-

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By research site
University of Chicago· Chicago, IL

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