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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021268 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of tocladesine in treating patients who have recurrent or progressive metastatic colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: tocladesine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study Of Tocladesine In Patients With Colorectal Carcinoma Following Therapy With 5-FU And Irinotecan |
Study Start Date: | April 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive tocladesine IV continuously on days 1-5 and 8-12. Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tocladesine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 14 additional patients are treated at this dose level.
PROJECTED ACCRUAL: A total of 3-38 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of metastatic carcinoma of the colon or rectum
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 |
Study Chair: | Lee S. Rosen, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068764, UCLA-0006008, ICN-2000-1, NCI-G01-1979 |
Study First Received: | July 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00021268 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 Immunologic Factors Rectal Neoplasms Gastrointestinal Diseases 8-chloro-cyclic adenosine monophosphate Irinotecan Colonic Diseases Rectal Neoplasm Intestinal Diseases Rectal Diseases |
Recurrence Intestinal Neoplasms Carcinoma Digestive System Diseases Rectal Cancer Fluorouracil Gastrointestinal Neoplasms Adenosine Colorectal Neoplasms |
Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Colonic Diseases 8-chloro-cyclic adenosine monophosphate Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |