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

NCT00314353 | Terminated Phase 2 Results

• 1 other identifier: NSABP FC-BV-003
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Keywords

NSABP; bevacizumab; capecitabine; oxaliplatin; irinotecan; rectal cancer; colon cancer; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Study Arms (2)

1

EXPERIMENTAL

Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine

2

EXPERIMENTAL

Drug: Bevacizumab; Drug: Capecitabine; Drug: Irinotecan

Interventions

Bevacizumab 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.

Also known as: Avastin

1; 2

Oxaliplatin DRUG

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

Also known as: Eloxatin

1

Capecitabine 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

Also known as: Xeloda

1; 2

Irinotecan DRUG

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

Also known as: Camptosar

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• Genentech, Inc.: collaborator
• Hoffmann-La Roche: collaborator
• International Drug Development Institute: collaborator

Study Sites (1)

NSABP Operations Center

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms

Interventions

Bevacizumab; Oxaliplatin; Capecitabine; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids

Limitations and Caveats

The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.

Results Point of Contact

• Title: Diana Gosik
• Organization: NSABP Foundation, Inc.

diana.gosik@nsabp.org

412-330-4692

Study Officials

• Norman Wolmark, MD

  NSABP Foundation Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: April 13, 2006
• Study Start: March 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2010
• Last Updated: October 6, 2021
• Results First Posted: December 2, 2008

Record last verified: 2021-10

Locations

US (1)