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Phase II Chemotherapy with Amonafide for Patients with Stage III or IV non-Small Cell Lung Cancer (Summary Last Modified 05/88)
Basic Trial Information
Objectives I. Evaluate the antitumor activity of amonafide in patients with Stage III or IV non-small cell lung cancer who have not received prior chemotherapy. II. Characterize more fully the toxicity of amonafide in this patient population when treated daily for 5 days every 3 weeks. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients at least 18 years of age who have histologically confirmed Stage III or IV non-small cell lung cancer that is not curable by surgery or radiotherapy. Prior chemotherapy excludes; only one prior therapy with a biological regimen not including IL-2 and LAK cells is permitted. Patients must have measurable or evaluable indicator lesions that have not been irradiated; there may have been no radiotherapy to major bone marrow-containing areas for 3 weeks prior to start of therapy. Pleural effusions, bone metastases, brain metastases, elevated enzyme levels, and lesions on radionuclide scans are not acceptable as sole indicator lesions. A Karnofsky performance status of 50% or better, WBC of at least 4,000, platelet count of at least 150,000, bilirubin no greater than 1.5 mg%, and serum creatinine of no more than 1.5 mg% or a creatinine clearance of at least 50 cc/minute are required. Patients must have a stable heart rhythm, no active angina, and no clinical evidence of congestive heart failure; prior malignancy (except basal cell skin cancer) excludes. Expected Enrollment 14 patients will be studied initially; if any responses are seen, 11 additional patients will be entered for a total of 25 patients. Outline Nonrandomized study. Single-agent Chemotherapy. Nafidimide, Amonafide, NSC-308847. Trial Lead Organizations Memorial Sloan-Kettering Cancer Center
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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