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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms |
Drug: Bevacizumab Drug: Oxaliplatin Drug: Capecitabine Drug: Irinotecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- One-year Progression-free Survival (PFS) [ Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. ] [ Designated as safety issue: No ]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.
- Objective Response Rate [ Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- Overall Survival [ Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. ] [ Designated as safety issue: No ]
- Duration of Response [ Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. ] [ Designated as safety issue: No ]
| Enrollment: | 7 |
| Study Start Date: | March 2006 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Bevacizumab
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 Name: Avastin
Drug: Oxaliplatin
130 mg/m2 IV Day 1 every 21 days for eight cycles
Other Name: Eloxatin
Drug: Capecitabine
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 Name: Xeloda
|
| Experimental: 2 |
Drug: Bevacizumab
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 Name: Avastin
Drug: Capecitabine
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 Name: Xeloda
Drug: Irinotecan
200 mg/m2 IV Day 1 every 21 days for eight cycles
Other Name: Camptosar
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Pennsylvania | |
| NSABP Operations Center | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Principal Investigator: | Norman Wolmark, MD | NSABP Foundation, Inc. |
More Information
No publications provided
| Responsible Party: | Norman Wolmark, MD, NSABP Foundation, Inc. |
| ClinicalTrials.gov Identifier: | NCT00314353 History of Changes |
| Other Study ID Numbers: | NSABP FC-BV-003 |
| Study First Received: | April 11, 2006 |
| Results First Received: | November 7, 2008 |
| Last Updated: | June 8, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):
|
NSABP bevacizumab capecitabine oxaliplatin |
irinotecan rectal cancer colon cancer colorectal cancer |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Oxaliplatin Irinotecan Capecitabine Bevacizumab |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013