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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Oxaliplatin
* Drug: Capecitabine
* Drug: Irinotecan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Bevacizumab<br>* 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.<br>* Other names: Avastin;Drug: Oxaliplatin<br>* 130 mg/m2 IV Day 1 every 21 days for eight cycles<br>* Other names: Eloxatin;Drug: Capecitabine<br>* 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<br>* Other names: Xeloda;|
| Experimental: 2<br> | Drug: Bevacizumab<br>* 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.<br>* Other names: Avastin;Drug: Capecitabine<br>* 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<br>* Other names: Xeloda;Drug: Irinotecan<br>* 200 mg/m2 IV Day 1 every 21 days for eight cycles<br>* Other names: Camptosar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-year Progression-free Survival (PFS) | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. | 
| Toxicity - Adverse Events |  | 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 |  | Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. | 
| Duration of Response |  | Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSABP, bevacizumab, capecitabine, oxaliplatin, irinotecan, rectal cancer, colon cancer, colorectal cancer