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

Colon Cancer Clinical Trial

Official title:

A Randomized Phase II Study of Modified FOLFOX6 (Infusional 5-Fluorouracil/Leucovorin, Oxaliplatin) and Bevacizumab With or Without Cetuximab in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193219
• Other study ID #: SCRI GI 64
• Status: Completed
• Phase: Phase 2
• Start date: July 2005
• Est. completion date: July 2010

Study information

• Verified date: December 2021
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2010
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Chattanooga Oncology and Hematology Associates	Chattanooga	Tennessee
United States	St. Louis Cancer Care	Chesterfield	Missouri
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Oncology Hematology Associates of SW Indiana	Evansville	Indiana
United States	Jackson Oncology Associates	Jackson	Mississippi
United States	Consultants in Blood Disorders and Cancer	Louisville	Kentucky
United States	Tennessee Oncology	Nashville	Tennessee
United States	Methodist Cancer Center	Omaha	Nebraska
United States	Mercy Hospital	Portland	Maine

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	18 months
Secondary	Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease	Progression Free Survival (PFS) is defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.	18 months
Secondary	Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death	Measured from the date of first treatment until the date of death from any cause	36 months
Secondary	Number of Patients With Adverse Events as a Measure of Safety With FOLFOX6 Combined With Bevacizumab and Cetuximab	The toxicity assessments were made according to the common terminology criteria for adverse events (CTCAE version 3.0) of the National Cancer Institute. Number of participants with Grade 1 to 5 adverse events are reported here.	18 months

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