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 Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-06-30

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.

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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.

Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

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.

Oxaliplatin

Intervention Type DRUG

130 mg/m2 IV Day 1 every 21 days for eight cycles

Capecitabine

Intervention Type DRUG

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

2

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

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.

Capecitabine

Intervention Type DRUG

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

Irinotecan

Intervention Type DRUG

200 mg/m2 IV Day 1 every 21 days for eight cycles

Interventions

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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.

Intervention Type DRUG

Oxaliplatin

130 mg/m2 IV Day 1 every 21 days for eight cycles

Intervention Type 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

Intervention Type DRUG

Irinotecan

200 mg/m2 IV Day 1 every 21 days for eight cycles

Intervention Type DRUG

Other Intervention Names

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Avastin Eloxatin Xeloda Camptosar

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No