Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer
- Conditions
- Colon Cancer
- Interventions
- Registration Number
- NCT00193219
- Lead Sponsor
- SCRI Development Innovations, LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Cetuximab 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 Intervention Bevacizumab 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 Intervention Oxaliplatin 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 Intervention 5-fluorouracil 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 Intervention Leucovorin 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
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment 18 months 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.
- Secondary Outcome Measures
Name Time Method 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 18 months 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.
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death 36 months Measured from the date of first treatment until the date of death from any cause
Number of Patients With Adverse Events as a Measure of Safety With FOLFOX6 Combined With Bevacizumab and Cetuximab 18 months 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.
Trial Locations
- Locations (10)
St. Louis Cancer Care
🇺🇸Chesterfield, Missouri, United States
Jackson Oncology Associates
🇺🇸Jackson, Mississippi, United States
Chattanooga Oncology and Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
Mercy Hospital
🇺🇸Portland, Maine, United States
Oncology Hematology Associates of SW Indiana
🇺🇸Evansville, Indiana, United States
Consultants in Blood Disorders and Cancer
🇺🇸Louisville, Kentucky, United States
Methodist Cancer Center
🇺🇸Omaha, Nebraska, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States