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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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ClinicalTrials.gov Identifier: NCT00314353
Recruitment Status : Terminated (The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.)
First Posted : April 13, 2006
Results First Posted : December 2, 2008
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Genentech, Inc.
Hoffmann-La Roche
International Drug Development Institute
Information provided by (Responsible Party):
NSABP Foundation Inc

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Bevacizumab Drug: Oxaliplatin Drug: Capecitabine Drug: Irinotecan Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. ]
  2. 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 ]
  3. Overall Survival [ Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. ]
  4. Duration of Response [ Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314353


Locations
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United States, Pennsylvania
NSABP Operations Center
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
NSABP Foundation Inc
Genentech, Inc.
Hoffmann-La Roche
International Drug Development Institute
Investigators
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Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc

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Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00314353     History of Changes
Other Study ID Numbers: NSABP FC-BV-003
First Posted: April 13, 2006    Key Record Dates
Results First Posted: December 2, 2008
Last Update Posted: May 8, 2018
Last Verified: April 2018
Keywords provided by NSABP Foundation Inc:
NSABP
bevacizumab
capecitabine
oxaliplatin
irinotecan
rectal cancer
colon cancer
colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Capecitabine
Oxaliplatin
Irinotecan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors