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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028015 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have recurrent or metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: SarCNU |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer |
| Study Start Date: | October 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond documentation of CR. Patients who achieve partial response (PR) receive 4 additional courses beyond documentation of PR.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-8 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal cancer
At least 1 unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Ontario | |
| Kingston Regional Cancer Centre | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Canada, Quebec | |
| Hopital Notre- Dame du CHUM | |
| Montreal, Quebec, Canada, H2L 4MI | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Study Chair: | Ralph P. W. Wong, MD, FRCPC | CancerCare Manitoba |
More Information
| Study ID Numbers: | CDR0000069113, CAN-NCIC-IND146, NCI-NCIC-146 |
| Study First Received: | December 7, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00028015 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
|
Digestive System Neoplasms Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Intestinal Diseases Rectal Diseases Pharmacologic Actions Intestinal Neoplasms |
Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms 2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide |