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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00077233 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, irinotecan, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one drug with a monoclonal antibody may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective with or without cetuximab in treating metastatic adenocarcinoma (cancer) of the colon or rectum.
PURPOSE: Randomized phase III trial to compare the effectiveness of combining fluorouracil and leucovorin with either irinotecan or oxaliplatin with or without cetuximab in treating patients who have metastatic cancer of the colon or rectum.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Biological: cetuximab Drug: 5-fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Trial Of Irinotecan /5-FU/ Leucovorin Or Oxaliplatin /5-FU / Leucovorin With And Without Cetuximab (C225) For Patients With Untreated Metastatic Adenocarcinoma Of The Colon or Rectum |
| Enrollment: | 238 |
| Study Start Date: | December 2003 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: FOLFIRI
irinotecan + 5-FU + leucovorin
|
Drug: 5-fluorouracil
400mg/sq m IV bolus then 2400mg/sq m IV infusion over 24-48 hours repeated every 2 weeks
Drug: irinotecan hydrochloride
180mg/sq m IV infusion over 90 min repeated every 2 weeks
Drug: leucovorin calcium
400mg/sq m IV infusion over 2 hours repeated every 2 weeks
|
|
Experimental: FOLFIRI + C225
Irinotecan + 5-FU + leucovorin + cetuximab
|
Biological: cetuximab
400mg/sq m IV infusion over 120 min on Day 1, then 250mg/sq m IV infusion over 60 min weekly
Other Name: C225
Drug: 5-fluorouracil
400mg/sq m IV bolus then 2400mg/sq m IV infusion over 24-48 hours repeated every 2 weeks
Drug: irinotecan hydrochloride
180mg/sq m IV infusion over 90 min repeated every 2 weeks
Drug: leucovorin calcium
400mg/sq m IV infusion over 2 hours repeated every 2 weeks
|
|
Active Comparator: FOLFOX
Oxaliplatin + leucovorin + 5-FU
|
Drug: 5-fluorouracil
400mg/sq m IV bolus then 2400mg/sq m IV infusion over 24-48 hours repeated every 2 weeks
Drug: leucovorin calcium
400mg/sq m IV infusion over 2 hours repeated every 2 weeks
Drug: oxaliplatin
85mg/sq m IV infusion over 120 minutes repeated every 2 weeks
|
|
Experimental: FOLFOX + C225
Oxaliplatin + leucovorin + 5-FU + cetuximab
|
Biological: cetuximab
400mg/sq m IV infusion over 120 min on Day 1, then 250mg/sq m IV infusion over 60 min weekly
Other Name: C225
Drug: 5-fluorouracil
400mg/sq m IV bolus then 2400mg/sq m IV infusion over 24-48 hours repeated every 2 weeks
Drug: leucovorin calcium
400mg/sq m IV infusion over 2 hours repeated every 2 weeks
Drug: oxaliplatin
85mg/sq m IV infusion over 120 minutes repeated every 2 weeks
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to prior adjuvant therapy (yes vs no) and prior pelvic radiotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
In all arms, courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 2 years and then every 3 months for 3 years.
PROJECTED ACCRUAL: Approximately 2,200 patients (550 per treatment arm) will be accrued for this study within 4.6 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic colorectal adenocarcinoma
Histologic or cytologic confirmation is not required for recurrent metastatic disease in patients with prior colorectal cancer treated with surgery unless either of the following criteria are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Neurologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent hormonal therapy except the following:
Radiotherapy
Surgery
Other
Contacts and Locations
Show 77 Study Locations| Study Chair: | Alan P. Venook, MD | University of California, San Francisco |
More Information
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00077233 History of Changes |
| Other Study ID Numbers: | CDR0000350016, U10CA031946, CALGB-80203 |
| Study First Received: | February 10, 2004 |
| Last Updated: | April 12, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
adenocarcinoma of the colon adenocarcinoma of the rectum recurrent colon cancer |
recurrent rectal cancer stage IV colon cancer stage IV rectal cancer |
|
Adenocarcinoma Colorectal Neoplasms Colonic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Fluorouracil Oxaliplatin Irinotecan Cetuximab Camptothecin Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents |