|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Collaborator: |
Australasian Gastro-Intestinal Trials Group |
| Information provided by: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00079066 |
Purpose
RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Best supportive care is the use of drugs and other treatments to improve the quality of life of patients. Combining cetuximab with best supportive care may slow the growth of the tumor and help patients live longer and more comfortably. It is not yet known whether cetuximab combined with best supportive care is more effective than best supportive care alone in treating metastatic epidermal growth factor receptor-positive colorectal cancer.
PURPOSE: This randomized phase III trial is studying cetuximab and best supportive care to see how well they work compared to best supportive care alone in treating patients with metastatic epidermal growth factor receptor-positive colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Quality of Life |
Biological: cetuximab Procedure: quality-of-life assessment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Active Control Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized Study of Cetuximab (Erbitux™, C225) and Best Supportive Care Versus Best Supportive Care in Patients With Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR)-Positive Colorectal Carcinoma |
| Study Start Date: | August 2003 |
| Study Completion Date: | February 2009 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, and then at 4, 8, 16, and 24 weeks (or until deterioration to ECOG PS 4 or hospitalization for end-of-life care).
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 20 months.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal cancer
Not amenable to standard curative therapy
Must have received a prior thymidylate synthase inhibitor (e.g., fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) in the adjuvant or metastatic setting
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Radiotherapy
Surgery
Other
Contacts and Locations
Show 33 Study Locations| Study Chair: | Derek Jonker, MD | Ottawa Regional Cancer Centre |
| Study Chair: | Chris Karapetis, MD | NHMRC Clinical Trials Centre |
More Information
| Study ID Numbers: | CDR0000353486, CAN-NCIC-CO17, AGITG-CAN-NCIC-CO17, BMS-CA225-025, IMCL-CAN-NCIC-CO17 |
| Study First Received: | March 8, 2004 |
| Last Updated: | March 5, 2010 |
| ClinicalTrials.gov Identifier: | NCT00079066 History of Changes |
| Health Authority: | United States: Federal Government |
|
quality of life stage IV colon cancer recurrent colon cancer recurrent rectal cancer stage IV rectal cancer |
|
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Mitosis Modulators Colonic Diseases Cetuximab Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Mitogens Colorectal Neoplasms |