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Phase II Chemotherapy with Anguidine for Advanced Gastrointestinal Malignancies
Basic Trial Information
Objectives I. Determine the efficacy of anguidine and survival in terms of response rate and median duration of response in the treatment of advanced gastrointestinal malignancies. II. Observe any factors predisposing to excessive myelosuppression and for other toxicities not observed during Phase I studies of this drug. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with surgically incurable measurable disease of histologically confirmed gastrointestinal malignancy, exiting from or not eligible for higher priority studies. Patients must not have had extensive radiation, chemotherapy or GI surgery in the last 3 weeks before study entry. A life expectancy of more than 6 weeks, serum creatinine below 2.0 mg%, BUN below 30 mg% and serum bilirubin less than 6.0 mg% are required. Poor-risk patients are those more than 65 years old, those with poor tolerance to prior chemotherapy, with extensive prior radiotherapy to myeloproliferative areas, with 3.0 to 6.0 mg% serum bilirubin or hepatic enzyme elevation. Expected Enrollment Protocol closed 10/79. Outline Nonrandomized study. Single-agent Chemotherapy. Anguidine, ANG, NSC-141537.Published Results Bukowski R, Vaughn C, Bottomley R, et al.: Phase II study of anguidine in gastrointestinal malignancies: a Southwest Oncology Group study. Cancer Treat Rep 66 (2): 381-3, 1982.[PUBMED Abstract] Trial Lead Organizations Southwest Oncology Group
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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