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Phase II Chemotherapy with 1,2,4-Triglycidylurazol for Advanced Colorectal Carcinoma
Basic Trial Information
Objectives I. Determine whether partial or complete responses can be achieved with 1,2,4-triglycidylurazol in patients with advanced colorectal carcinoma. II. Assess the probability of an actual response rate (in cases of partial or complete response) in patients treated with 1,2,4-triglycidylurazol, and determine whether further evaluation of therapeutic effectiveness is warranted. III. Further characterize the toxic effects of 1,2,4-triglycidylurazol in this group of patients. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients 75 years of age or less with a histologic diagnosis of recurrent or metastatic colorectal adenocarcinoma that is not amenable to curative surgery. Patients must have measurable or evaluable lesions with documented progression during the 2 months prior to entry. A performance status of 0-2 (WHO criteria), a life expectancy of greater than 3 months, and adequate renal, hepatic, and hematologic function are required. There may be no radiotherapy or chemotherapy during the 4 weeks prior to entry (6 weeks for nitrosoureas and mitomycin), and patients must have recovered from all toxic effects of prior therapy. Brain involvement and prior radiotherapy to indicator lesions exclude. There may be no previous or concurrent other malignancy except for in-situ carcinoma of the uterine cervix and adequately treated basal or squamous cell skin carcinoma. Patients who are poor medical risks because of nonmalignant systemic disease as well as those with active uncontrolled infection are ineligible. Expected Enrollment If there are 0, 1, 2, 3, or 4 or more responses among the first 14 patients treated, then 0, 1, 6, 9, or 11 additional patients will be entered, respectively. Outline Nonrandomized study. Single-agent Chemotherapy. 1,2,4-Triglycidylurazol, TGU. Trial Lead Organizations European Organization for Research and Treatment of Cancer
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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