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Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005981 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: O6-benzylguanine Drug: carmustine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive O6-benzylguanine (BG) IV over 1 hour and carmustine IV over 1 hour (beginning 1 hour after completion of BG infusion) on day 1.
Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study within 1.7-3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Smitha Krishnamurthi, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067969, CWRU-1298, NCI-89 |
Study First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005981 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 Rectal Neoplasms Gastrointestinal Diseases Carmustine Colonic Diseases Rectal Neoplasm Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Carcinoma Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms O(6)-benzylguanine Antineoplastic Agents, Alkylating Alkylating Agents Colorectal Neoplasms |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Carmustine Enzyme Inhibitors Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms O(6)-benzylguanine Antineoplastic Agents, Alkylating Alkylating Agents Colorectal Neoplasms |