Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colon Cancer |
Drug: Bevacizumab Drug: Cetuximab Drug: 5-fluorouracil Drug: Leucovorin Drug: Oxaliplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]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.
- 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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]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 [ Time Frame: 36 months ] [ Designated as safety issue: No ]Measured from the date of first treatment until the date of death from any cause
- Safety of FOLFOX6 Combined With Bevacizumab and Cetuximab [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Enrollment: | 36 |
| Study Start Date: | July 2005 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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 |
Drug: Bevacizumab
5 mg/kg IV
Other Name: Avastin
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
Other Name: Erbitux
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)
Other Names:
Drug: Leucovorin
350 mg IV
Other Name: Folinic Acid
Drug: Oxaliplatin
85 mg/m2 IV
Other Name: Eloxatin
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Indiana | |
| Oncology Hematology Associates of SW Indiana | |
| Evansville, Indiana, United States, 47714 | |
| United States, Kentucky | |
| Consultants in Blood Disorders and Cancer | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Maine | |
| Mercy Hospital | |
| Portland, Maine, United States, 04101 | |
| United States, Maryland | |
| Center for Cancer and Blood Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Mississippi | |
| Jackson Oncology Associates | |
| Jackson, Mississippi, United States, 39202 | |
| United States, Missouri | |
| St. Louis Cancer Care | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, Nebraska | |
| Methodist Cancer Center | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Ohio | |
| Oncology Hematology Care | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Tennessee | |
| Chattanooga Oncology and Hematology Associates | |
| Chattanooga, Tennessee, United States, 37404 | |
| Tennessee Oncology | |
| Nashville, Tennessee, United States, 37203 | |
| Principal Investigator: | David R. Spigel, MD | Sarah Cannon Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00193219 History of Changes |
| Other Study ID Numbers: | SCRI GI 64 |
| Study First Received: | September 12, 2005 |
| Results First Received: | December 7, 2012 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sarah Cannon Research Institute:
|
Colon Cancer |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Oxaliplatin Bevacizumab |
Cetuximab Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients |
ClinicalTrials.gov processed this record on May 23, 2013