Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) ImClone Systems International Drug Development Institute Esoterix, Inc. |
---|---|
Information provided by: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
ClinicalTrials.gov Identifier: | NCT00803647 |
FC-6 is a Phase II, multi-center clinical trial for patients with unresectable, wild-type K-RAS, colorectal cancer with metastases confined to the liver. Liver metastases must be determined by FC-6 criteria to be unresectable, and the CRC tumor (primary or metastatic) must be found to be wild-type K-RAS. Patients with mutant K-RAS tumors are ineligible. K-RAS testing can be done through the local hospital or a tumor sample can be submitted to the FC-6 central lab (Esoterix Clinical Trial Services).
A primary aim of this study is to evaluate the surgical conversion rate using cytotoxic combination chemotherapy and biologic therapy with cetuximab, a monoclonal antibody targeted against the epidermal growth factor receptor. A second primary aim is to evaluate the safety and tolerability of a chemotherapy/targeted therapy regimen in this patient population. Secondary aims include determination of clinical response rate, recurrence-free survival for patients undergoing complete resection and/or ablation of liver metastases, and overall survival.
Condition | Intervention | Phase |
---|---|---|
Metastatic Colorectal Cancer |
Biological: cetuximab Drug: 5-FU Drug: oxaliplatin Drug: leucovorin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study to Determine the Surgical Conversion Rate in Patients Receiving Neoadjuvant mFOLFOX7 + Cetuximab for Unresectable Wild-Type K-RAS Colorectal Cancer With Metastases Confined to the Liver |
Estimated Enrollment: | 60 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | June 2016 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
treatment: Experimental
mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
|
Biological: cetuximab
500 mg/m2 IV every two weeks on days 1, 15, 29, and 43 of each 56 day cycle, for a total of 3 cycles (cetuximab dose will be escalated by 100 mg/m2 every 2 weeks to a maximum dose of 800 mg/m2 if skin rash is less than or equal to grade 1 at the time of retreatment and if the patient is not experiencing any other greater than or equal to grade 3 toxicity attributed to cetuximab).
Drug: 5-FU
3000 mg/m2 IV continuous infusion over 46 hours every two weeks on days 1, 15, 29, and 43 of each 56 day cycle, for a total of 3 cycles.
Drug: oxaliplatin
85 mg/m2 IV every two weeks on days 1, 15, 29, and 43 of each 56 day cycle, for a total of 3 cycles.
Drug: leucovorin
400 mg/m2 IV every two weeks on days 1, 15, 29, and 43 of each 56 day cycle, for a total of 3 cycles.
|
All patients will receive the FC-6 study treatment regimen every 2 weeks during each 8-week cycle for a total of 3 cycles.
Baseline imaging of the chest, abdomen, and pelvis will be performed. CT scan or MRI of the abdomen will be performed after 1 cycle of neoadjuvant therapy to assess clinical response and resectability of liver metastases. If liver metastases are not deemed to be resectable at this assessment, but tumor assessment demonstrates stable disease or partial response, therapy will continue with re-assessment for clinical response and resectability after Cycle 2 and, if necessary, after Cycle 3.
After a minimum of 1 cycle of therapy, patients who meet the guidelines for resection of liver metastases will undergo liver metastasectomy (tumor resection and/or ablation) as soon as judged technically feasible by the hepatic surgeon in order to minimize chemotherapy damage to the liver and morbidity from surgery. At the investigator's discretion, additional doses of the chemotherapy regimen may continue to be administered until 2 weeks before the planned date of surgery.
The surgical goal is to perform a curative (R0) resection and/or ablation. If curative surgery was performed and if only 1 or 2 cycles of therapy were administered before surgery, postoperative therapy using the same regimen will resume 4-6 weeks following surgery to complete 3 cycles of study treatment. Following discontinuation of study therapy, all patients who undergo R0 resection (with or without ablation) will be followed every 3 months for the first 2 years on the study and then every 6 months for years 3 through 5.
Further therapy for patients who do not undergo R0 resection/ablation will be at the investigator's discretion. These patients will only be followed for vital status every 12 months for the remainder of the 5-year period following study entry.
A total sample size of 60 patients will be enrolled in the FC-6 trial.
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Conditions for patient eligibility
Conditions for patient ineligibility
Contact: Diana Gosik, RN, BS | 412-330-4692 | diana.gosik@nsabp.org |
Principal Investigator: | Norman Wolmark, MD | NSABP Foundation, Inc. |
Responsible Party: | NSABP Foundation, Inc. ( Norman Wolmark, MD ) |
Study ID Numbers: | NSABP FC-6 |
Study First Received: | December 4, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00803647 |
Health Authority: | United States: Institutional Review Board |
NSABP Cetuximab FOLFOX7 Oxaliplatin Leucovorin 5-FU colorectal cancer |
KRAS wild type metastatic colorectal cancer Erbitux Eloxatin Liver resection Liver ablation Metastasectomy |
Digestive System Neoplasms Gastrointestinal Diseases Cetuximab Colonic Diseases Leucovorin Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Oxaliplatin Digestive System Diseases Fluorouracil Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |
Neoplastic Processes Neoplasms Vitamin B Complex Pathologic Processes Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Growth Substances Vitamins Physiological Effects of Drugs Micronutrients Pharmacologic Actions |