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| Sponsored by: |
Washington University School of Medicine |
|---|---|
| Information provided by: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00537823 |
Purpose
The purpose of this study is to determine the effect of short-duration (two months) pre-operative FOLFOX/Cetuximab chemotherapy on post-operative problems after liver surgery for patients with metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Metastases |
Drug: FOLFOX 6 Drug: Cetuximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Effect of Short-Duration Preoperative Neoadjuvant Therapy With a Combination of FOLFOX and Cetuximab on Morbidity After Liver Resection for Colorectal Cancer Metastases |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
FOLFOX + C225
|
Drug: FOLFOX 6
Pre-Operative: The schedule includes oxaliplatin 85 mg/m² IV over two hours, leucovorin 400 mg/m² IV over two hours, and 5FU 400 mg/m² IV bolus followed by and infusion 1200 mg/m²/day for 2 days. The 5FU infusion must be given after the leucovorin infusion. Leucovorin can be given either concurrently with oxaliplatin through a separate infusion port or may be given after the oxaliplatin infusion is complete. This regimen is repeated every 2 weeks for a total of 2 months. Post-Operative: Identical regimen to preoperative therapy only given over 4 months.
Drug: Cetuximab
Pre-operative: Cetuximab is given weekly as a 400 mg/m² IV loading dose on week one over two hours and 250 mg/m² IV over one hour weeks 2 through 8. Total treatment lasts 2 months. Post-operative: Identical regimen to preoperative therapy only given over 4 months.
|
Although early stage, localized colon and rectal cancers are associated with 5 year survival rates of nearly 90%, only a minority of patients present with localized disease. Unfortunately, at the time of their initial presentation, approximately 35% of patients with colon or rectal cancer have metastatic disease. Nearly two thirds of these patients with stage IV disease have evidence of extrahepatic spread and have a median overall survival rate of 8-10 months in the absence of further treatment. Even with the most intensive chemotherapeutic regimens, the median overall survival for these patients ranges from 12 months to 20 months. However, a small subset of patients with stage IV disease has isolated hepatic metastatic disease and can undergo resection. The patients with completely resected liver metastases enjoy a significantly higher overall five-year survival, which is as high as 58% in carefully selected patients. Ten-year overall survival has been reported in 22% of patients. Despite this improvement, the five-year disease-free survival for these patients is at best 35%, with hepatic recurrences occurring in 46%.
The fact that adjuvant chemotherapy improves the three-year survival rate for stage II disease and five-year survival rates for stage III disease implies that it can treat micrometastatic disease in some fraction of patients. Because micrometastatic disease is likely the cause of the high recurrence rate in patients who undergo liver resection, there is a clear biologic rationale for using postoperative adjuvant chemotherapy after liver resection. Although this strategy is a common practice in many centers, no convincing data that this improves survival have been reported. A large randomized phase III trial (EORTC 40983) examining this question is currently ongoing and effect on survival has not yet been reported. Given that systemic chemotherapy after liver resection remains of unproven benefit at the present time, many have wondered if preoperative treatment might have more promise in improving recurrence rates.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: David Linehan, MD | 314-747-2938 | linehand@wustl.edu |
| Contact: Farley Johnson | 314-747-9202 | johnsonf@ccadmin.wustl.edu |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Leslie Foster, BS, MHA 314-362-8547 fosterl@ccadmin.wustl.edu | |
| Contact: Jenny Edrington 314-362-0202 edringtj@ccadmin.wustl.edu | |
| Principal Investigator: David Linehan, MD | |
| Sub-Investigator: Emily R Winslow, MD | |
| Sub-Investigator: Joel Picus, MD | |
| Sub-Investigator: William Hawkins, MD | |
| Sub-Investigator: Steven M Strasberg, MD | |
| Sub-Investigator: Benjamin R Tan, MD | |
| Sub-Investigator: James Lewis, MD | |
| Sub-Investigator: Sanjeev Bhalla, MD | |
| Sub-Investigator: Kathryn Trinkaus, PhD | |
| Principal Investigator: | David Linehan, MD | Washington University School of Medicine |
More Information
| Responsible Party: | Washington University School of Medicine ( David Linehan, MD ) |
| Study ID Numbers: | 07-0182 |
| Study First Received: | September 27, 2007 |
| Last Updated: | November 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00537823 |
| Health Authority: | United States: Institutional Review Board |
|
Colorectal Cancer Metastasis Neoadjuvant Therapy |
|
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 Pathologic Processes Neoplasms by Site |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
