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 - Full Text View

Sponsors and Collaborators:	National Surgical Adjuvant Breast and Bowel Project (NSABP) Genentech Hoffmann-La Roche International Drug Development Institute
Information provided by:	National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:	NCT00314353

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 II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride Capecitabine Bevacizumab Oxaliplatin Creatinine BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

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 ]

Secondary Outcome Measures:

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 ]
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 ]
Overall Survival [ 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 ]

Enrollment:	7
Study Start Date:	March 2006
Estimated Study Completion Date:	May 2009
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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. Drug: Oxaliplatin 130 mg/m2 IV Day 1 every 21 days for eight cycles 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
2: Experimental	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. 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 Drug: Irinotecan 200 mg/m2 IV Day 1 every 21 days for eight cycles

Arms

Assigned Interventions

1: Experimental

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.

Drug: Oxaliplatin

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

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

2: Experimental

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.

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

Drug: Irinotecan

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

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

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

National Surgical Adjuvant Breast and Bowel Project (NSABP)

Genentech

Hoffmann-La Roche

International Drug Development Institute

Investigators

Principal Investigator:

Norman Wolmark, MD

NSABP Foundation, Inc.

More Information

Responsible Party:	NSABP Foundation, Inc. ( Norman Wolmark, MD )
Study ID Numbers:	NSABP FC-BV-003
Study First Received:	April 11, 2006
Results First Received:	November 7, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00314353
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

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Bevacizumab
Intestinal Diseases

Rectal Diseases
Intestinal Neoplasms
Rectal neoplasm
Oxaliplatin
Digestive System Diseases
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 10, 2009