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

This study has been terminated.
(The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.)
Sponsor:
Collaborators:
Genentech, Inc.
Hoffmann-La Roche
International Drug Development Institute
Information provided by:
NSABP Foundation Inc
ClinicalTrials.gov Identifier:
NCT00314353
First received: April 11, 2006
Last updated: June 8, 2010
Last verified: June 2010
  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

Resource links provided by NLM:


Further study details as provided by NSABP Foundation Inc:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314353

Locations
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
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 NSABP Foundation Inc:
NSABP
bevacizumab
capecitabine
oxaliplatin
irinotecan
rectal cancer
colon cancer
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Bevacizumab
Capecitabine
Fluorouracil
Irinotecan
Oxaliplatin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014