Clinical trial NCT00193219: Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colon Cancer
Keywords: Colon Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
timeFrame: 18 months
Secondary outcomes:
measure: 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
timeFrame: 18 months
measure: Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
timeFrame: 36 months
measure: Number of Patients With Adverse Events as a Measure of Safety With FOLFOX6 Combined With Bevacizumab and Cetuximab
timeFrame: 18 months
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Oncology Hematology Associates of SW Indiana
state: Indiana
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: Portland
country: United States
facility: Mercy Hospital
state: Maine
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Jackson
country: United States
facility: Jackson Oncology Associates
state: Mississippi
city: Chesterfield
country: United States
facility: St. Louis Cancer Care
state: Missouri
city: Omaha
country: United States
facility: Methodist Cancer Center
state: Nebraska
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Chattanooga
country: United States
facility: Chattanooga Oncology and Hematology Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: David R. Spigel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.