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Phase II Master Protocol for Advanced, Recurrent Pelvic Malignancies: AT-125
Basic Trial Information
Objectives I. Screen new agents or drug combinations for activity in patients with advanced or recurrent pelvic malignancies using a rejection-type study design (Master Protocol GOG-26). II. Determine, in this portion of Master Protocol GOG-26, the efficacy of AT-125 in patients with advanced or recurrent pelvic malignancies that are resistant to higher priority methods of treatment. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with histologically confirmed, advanced, recurrent, persistent, metastatic or local gynecologic cancer with documented disease progression who are not eligible for higher priority protocols. There must be measurable lesions that can be followed for tumor response. Patients must have a GOG performance grade of 0, 1, or 2, and there must be adequate bone marrow (granulocyte count at least 2,000/cumm and platelets at least 150,000/cumm), renal (BUN at most 25 mg%, creatinine at most 1.5 mg%), and hepatic (bilirubin at most 1.0 mg%, SGOT at most 50 IU) function. Patients with abnormal liver function due to metastatic liver tumor are eligible. Patients must have recovered from the effects of recent surgery, radiotherapy, or chemotherapy; they may have received no chemotherapy for 3 weeks prior to entry. There must be no prior treatment with the study agent. Patients with cervical and endometrial cancer are allowed only one prior chemotherapy trial; patients with ovarian cancer, uterine sarcoma, or other gynecologic malignancies are allowed no more than two prior chemotherapy trials. Patients with a history of seizures and/or psychosis are ineligible. Expected Enrollment 25 evaluable patients per disease site are required. Because of reported toxicities, an immediate hold was placed on patient entry in October 1983. Protocol closed to patient entry February 1984. Outline Nonrandomized study. Single-agent Chemotherapy. Acivicin, AT-125, NSC-163501.Published Results McGuire WP, Blessing JA, DiSaia PJ, et al.: Phase II trial of acivicin in patients with advanced epithelial ovarian carcinoma. A Gynecologic Oncology Group Study. Invest New Drugs 4 (1): 49-52, 1986.[PUBMED Abstract] Trial Lead Organizations Gynecologic 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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