- ICH GCP
- US Clinical Trials Registry
- 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
Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15212
- NSABP Operations Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
7.5 mg/kg IV Day 1 every 21 days for eight cycles* *For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.
Other Names:
130 mg/m2 IV Day 1 every 21 days for eight cycles
Other Names:
850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*# *For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID
Other Names:
|
Experimental: 2
|
7.5 mg/kg IV Day 1 every 21 days for eight cycles* *For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.
Other Names:
850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*# *For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID
Other Names:
200 mg/m2 IV Day 1 every 21 days for eight cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
One-year Progression-free Survival (PFS)
Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Outcome measure was not assessed due to early study closure.
The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
|
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective Response Rate
Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Toxicity - Adverse Events
Time Frame: 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
|
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
|
Overall Survival
Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Duration of Response
Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Topoisomerase I Inhibitors
- Capecitabine
- Oxaliplatin
- Bevacizumab
- Irinotecan
Other Study ID Numbers
- NSABP FC-BV-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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