Combination Chemotherapy and Bevacizumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Colorectal Cancer

Part of paid clinical trials in San Antonio, Texas.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00070122
Phase
PHASE3
Status
Terminated

Conditions

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage III Colon Cancer
  • Stage III Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer

Eligibility Criteria

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

Interventions

  • oxaliplatin — DRUG
    Given IV
  • leucovorin calcium — DRUG
    Given IV
  • capecitabine — DRUG
    Given orally
  • bevacizumab — BIOLOGICAL
    Given IV
  • fluorouracil — DRUG
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

Drugs used in chemotherapy, such as oxaliplatin, leucovorin, fluorouracil, and capecitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen with bevacizumab works better in treating colorectal cancer. This randomized phase III trial is studying giving two different combination chemotherapy regimens together with bevacizumab and comparing how well they work in treating patients with locally advanced, metastatic, or recurrent colorectal cancer

Key Dates

First listed
Oct 7, 2003
Start date
Apr 30, 2004
Status verified
Jan 2013
Primary completion
Jan 31, 2007

Study Design

Enrollment
2,200 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (oxaliplatin, leucovorin calcium, fluorouracil)
    Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1. Patients are further randomized to receive bevacizumab or placebo\* IV over 30-90 minutes on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: \*As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab.
  • Experimental: Arm II (oxaliplatin, capecitabine)
    Patients receive oxaliplatin IV over 2 hours on day 1and oral capecitabine on days 1-15. Patients are further randomized to receive bevacizumab or placebo\* as in arm I. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity NOTE: \*As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab.

Primary Outcome Measure

Overall survival in patients with colorectal cancer treated with fluorouracil/leucovorin calcium and oxaliplatin with and without becavizumab versus those treated with capecitabine and oxaliplatin with our without bevacizumab [ Time Frame: Up to 6 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Southwest Oncology GroupSan AntonioTexas78245-

Find similar trials in San Antonio, TX

By research site
Southwest Oncology Group· San Antonio, TX

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