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Phase II Evaluation of Piroxantrone in Patients with Gastric Carcinoma (Summary Last Modified 01/91)
Basic Trial Information
Objectives I. Assess the response rate and response duration of patients with gastric carcinoma treated with piroxantrone. II. Evaluate the qualitative and quantitative toxicities of piroxantrone administered to patients with gastric carcinoma in a Phase II study. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients at least 18 years of age with histologically proven adenocarcinoma of the stomach with gross unresectable residual disease that is locally advanced or metastatic, provided there is bidimensionally measurable disease. Patients must not have received prior chemotherapy, hormonal therapy, or biologic response modifier therapy, and they must not receive concomitant therapy while on protocol. At least one month must have elapsed since prior radiotherapy or surgery, and patients must have recovered from all therapy-related toxicities. A SWOG performance status of 2 or better is required, as are the following values for organ function parameters: granulocytes at least 1,500, platelets at least 100,000, serum creatinine and serum bilirubin each no greater than 1.5 mg/dl, and SGOT no more than 2.5 x institutional normal (no more than 5 x normal if there are hepatic metastases). Patients must not be receiving treatment for cardiac disease (arrhythmias, CHF, or coronary artery disease) and must not have had a myocardial infarction within the past year; the LVEF as measured by MUGA scan must be at least 45%. Aside from adequately treated basal or squamous cell skin cancers, in situ cervical cancer, and other cancer from which the patient has been disease-free for 5 years, there must be no prior malignancy. Pregnancy and lactation exclude, and patients of reproductive potential must practice effective contraception. Bloodwork and other body fluid analysis required for eligibility determination and imaging studies and physical examination for tumor measurement must be completed within 14 days prior to registration; screening exams other than blood/body fluid analysis and imaging studies of nonmeasurable disease or uninvolved organs must be completed within 42 days prior to registration. Expected Enrollment If 3-5 responses are observed in the first 20 patients, an additional 15 patients will be entered. Accrual is expected to be completed in 6 months. Outline Nonrandomized study. Single-agent Chemotherapy. Piroxantrone, NSC-349174.Published Results Hantel A, Tangen C, Gluck WL, et al.: Phase II trial of piroxantrone in gastric carcinoma. A Southwest Oncology Group study. Invest New Drugs 12 (2): 159-61, 1994.[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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