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Sponsors and Collaborators: |
Veeda Oncology Bristol-Myers Squibb Sanofi-Aventis |
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Information provided by: | Veeda Oncology |
ClinicalTrials.gov Identifier: | NCT00251485 |
This is a Phase II, open label, non-randomized study in patients with histologically or pathologically confirmed diagnosis of stage IIIB/IV, EGFR+ adenocarcinoma of the colon or rectum who have not received prior chemotherapy for their metastatic disease.
Primary Study Endpoint:
To assess the response rate, progression-free survival, and overall safety profile of a modified FOLFOX 6 plus cetuximab regimen in the first-line treatment of patients with metastatic colorectal cancer.
Secondary Study Endpoint(s):
To assess overall survival of patients with metastatic colorectal cancer who receive first-line therapy with a modified FOLFOX 6 + cetuximab regimen.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: Cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Official Title: | A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer |
Enrollment: | 82 |
Study Start Date: | March 2004 |
Study Completion Date: | June 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
The current treatment options for metastatic colon cancer are in need of further improvement. The three-drug combination of oxaliplatin with 5-FU/LV for the first-line treatment of metastatic colorectal cancer has shown a significant increase in response rate compared to IFL (irinotecan and bolus 5-FU plus leucovorin ) and IROX (irinotecan plus oxaliplatin. Cetuximab has shown activity with and without irinotecan in subjects with colorectal cancer refractory to irinotecan alone.30,31 Cetuximab has also been shown to be safe and effective when administered with infusional 5-FU/folinic acid plus irinotecan. These results suggest that the addition of cetuximab to a 5-FU/LV/oxaliplatin-based regimen (FOLFOX) used in the 1st line setting may lead to the development of more treatment options for subjects with advanced colorectal cancer.
This is a Phase II, open label, non-randomized study in patients with histologically or pathologically confirmed diagnosis of stage IIIB/IV, EGFR+ adenocarcinoma of the colon or rectum who have not received prior chemotherapy for their metastatic disease. Patients will receive a modified FOLFOX 6 regimen (5-FU, leucovorin, and oxaliplatin) every 2 weeks in combination with cetuximab given weekly. Patients will be evaluated for response and progression-free survival. Overall survival will also be evaluated, as well as the safety profile of the regimen.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1.
Exclusion Criteria:
United States, Texas | |
Veeda Oncology | |
Houston, Texas, United States, 77042 |
Principal Investigator: | Ralph Boccia, MD | Veeda Oncology |
Study ID Numbers: | I-03-002 |
Study First Received: | November 8, 2005 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00251485 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metastatic 1st line colorectal cancer |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Cetuximab Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Digestive System Neoplasms Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Cetuximab Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |