Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer

NCT ID: NCT00193219

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2010-07-31

Brief Summary

This trial will evaluate the combination of modified infusional 5-fluorouracil/ leucovorin, oxaliplatin (FOLFOX6), bevacizumab, and cetuximab in patients with metastatic colorectal cancer. FOLFOX6 has proven to be a safe and effective regimen in first line treatment of advanced colorectal cancer. The role of epidermal growth factor (EGFR) inhibitors in an earlier treatment setting in combination with optimal chemotherapy regimens is an important emerging question.

Detailed Description

All patients received cetuximab: 400 mg/m2 (first cycle only) administered intravenously (IV) on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8. Day 1 cetuximab was immediately followed by bevacizumab 5 mg/kg IV, oxaliplatin 85 mg/m2 IV, and 5-fluorouracil 400 mg/m2 IV bolus, followed by 2400 mg/m2 administered as a continuous infusion over 46 hours via a pump (outpatient) and leucovorin 350 mg IV (modified FOLFOX6). Cycles were 14 days.

Conditions

Colon Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Bevacizumab 5 mg/kg IV

Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8

5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient)

Leucovorin 350 mg IV

Oxaliplatin 85 mg/m2 IV

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

5 mg/kg IV

Cetuximab

Intervention Type: DRUG

400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8

5-fluorouracil

Intervention Type: DRUG

400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient)

Leucovorin

Intervention Type: DRUG

350 mg IV

Oxaliplatin

Intervention Type: DRUG

85 mg/m2 IV

Interventions

Bevacizumab

5 mg/kg IV

Intervention Type: DRUG

Cetuximab

400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8

Intervention Type: DRUG

5-fluorouracil

400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient)

Intervention Type: DRUG

Leucovorin

350 mg IV

Intervention Type: DRUG

Oxaliplatin

85 mg/m2 IV

Intervention Type: DRUG

Other Intervention Names

Avastin; Erbitux; 5-FU; Adrucil; Folinic Acid; Eloxatin

Eligibility Criteria

Inclusion Criteria

To be included in the study, you must meet the following criteria:

• Metastatic colorectal cancer confirmed by a biopsy sample
• 18 years of age or older
• Evidence of disease progression at time of study entry
• At least one prior adjuvant chemotherapy regimen
• No prior therapy for metastatic disease
• Measurable disease
• Able to perform activities of daily living with minimal assistance
• Adequate bone marrow, kidney, and liver function
• Tumor tissue available for assessment of EGFR
• Signed informed consent

Exclusion Criteria

You cannot participate in the study if any of the following apply to you:

• Treatment with a previous regimen for metastatic disease
• Prior treatment with any EGFR inhibitor or anti-angiogenic agents
• Brain or nervous system metastases
• History of severe thromboembolic event
• Clinical evidence or history of bleeding or coagulopathy
• History of stroke or heart attack within six months
• Poorly controlled hypertension
• Non-healing wound, ulcer, or bone fracture
• History of abdominal fistula, perforation, or abscess within six months
• Other uncontrolled or significant disease or medical condition

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David R. Spigel, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, United States

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, United States

Mercy Hospital

Portland, Maine, United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Jackson Oncology Associates

Jackson, Mississippi, United States

St. Louis Cancer Care

Chesterfield, Missouri, United States

Methodist Cancer Center

Omaha, Nebraska, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Chattanooga Oncology and Hematology Associates

Chattanooga, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Countries

United States

References

Spigel DR, Greco FA, Waterhouse D, Shipley D, Lane CM, Vazquez ER, Clark BL, Infante JR, Bendell JC, Burris HA 3rd, Hainsworth JD. Phase II trial of FOLFOX6, bevacizumab, and cetuximab in the first-line treatment of metastatic colorectal cancer. Clin Adv Hematol Oncol. 2010 Jul;8(7):480-5, 498.

Reference Type: BACKGROUND

PMID: 20864916 (View on PubMed)

Related Links

http://www.clinicaladvances.com/index.php/our_publications/hem_onc-article/1739/

Related Info

Other Identifiers

SCRI GI 64

Identifier Type: -

Identifier Source: org_study_id