Clinical trial NCT00314353: Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon
Official title: Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Keywords: NSABP
bevacizumab
capecitabine
oxaliplatin
irinotecan
rectal cancer
colon cancer
colorectal cancer
Lead sponsor: NSABP Foundation Inc
Sponsor class: NETWORK
Collaborators: name: Genentech, Inc.
name: Hoffmann-La Roche
name: International Drug Development Institute
First posted: 2006-04-13
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.

Detailed description: Due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and capecitabine with irinotecan (CAPIRI). Given the data documenting the improved efficacy for 5-FU based chemotherapy in combination with bevacizumab, it is important to investigate the potential advantages of adding this agent to regimens containing capecitabine.

Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum)
* Evidence of adequate organ function (such as liver, kidneys, etc.)

Exclusion Criteria:

* Diagnosis of anal cancer
* Patients who are candidates for surgery
* Patients who have received previous treatments
* Pregnant or lactating women
* History of chronic disease(s) or other serious medical conditions

Primary outcomes:
measure: One-year Progression-free Survival (PFS)
timeFrame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
measure: Toxicity - Adverse Events
timeFrame: Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
measure: Overall Survival
timeFrame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
measure: Duration of Response
timeFrame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: NSABP Operations Center
state: Pennsylvania
Study officials:
affiliation: NSABP Foundation Inc
name: Norman Wolmark, MD
role: PRINCIPAL_INVESTIGATOR
References: