Gemcitabine With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00088894
Phase
PHASE3
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

  • gemcitabine hydrochloride — DRUG
    Given IV
  • bevacizumab — BIOLOGICAL
    Given IV
  • placebo — OTHER
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacogenomic studies — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies

Study Details

This randomized phase III trial is studying gemcitabine and bevacizumab to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Combining gemcitabine with bevacizumab may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without bevacizumab in treating pancreatic cancer.

Key Dates

First listed
Aug 5, 2004
Start date
Jun 30, 2004
Status verified
Jun 2013
Primary completion
Jun 30, 2006

Study Design

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

Arms

  • Experimental: Arm I (gemcitabine hydrochloride, bevacizumab)
    Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15.
  • Active Comparator: Arm II (gemcitabine hydrochloride, placebo)
    Patients receive gemcitabine IV as in arm I and placebo IV over 30-90 minutes on days 1 and 15.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From trial entry until death, assessed up to 7 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cancer and Leukemia Group BChicagoIllinois60606-

Find similar trials in Chicago, IL

By research site
Cancer and Leukemia Group B· Chicago, IL

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