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Phase I/II Pilot Study of Intensive Combination Chemotherapy with Sequential ACE (ADR/CTX/VP-16) and PCE (CACP/CTX/VP-16) plus Chest Irradiation and Warfarin in Patients with Limited Small Cell Carcinoma of the Lung
Basic Trial Information
Objectives I. Determine whether combined modality therapy with 3 courses of ACE (adriamycin/cyclophosphamide/VP-16213) followed by PCE (cis-platinum/cyclophosphamide/VP-16213) administered concomitantly with local chest irradiation and prophylactic cranial irradiation followed by 3 courses of ACE is technically feasible in terms of toxicity, local complications, and an acceptable CR rate in patients with limited small cell lung cancer. II. Determine whether warfarin can be given concomitantly with the above therapy. III. Assess the toxicity of PCE chemotherapy combined with chest irradiation after 3 courses of ACE in these patients. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients over the age of 21 years with measurable or evaluable, histologically (preferred) or cytologically confirmed small cell anaplastic, undifferentiated bronchogenic carcinoma provided that disease is limited to one hemithorax with or without mediastinal nodes or with or without bilateral supraclavicular node involvement. The presence of a pleural effusion, whether cytologically positive or negative, excludes. Patients must not have received prior surgical resection, chemotherapy, or radiotherapy, and there must have been no antecedent indication for current warfarin therapy. There must be laboratory evidence of adequate liver, kidney, and bone marrow function, and patients must have adequate nutritional status, a performance status of 0-2, and a life expectancy of greater than 2 months. Aside from curatively treated carcinoma in situ of the cervix and basal cell skin cancer, there may be no previous or concurrent second malignancy. Patients must be free from uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months, congestive heart failure, and severe angina (patients with persistent EKG abnormalities from a myocardial infarction more than 6 months prior to admission are eligible). The following contraindications to anticoagulant therapy exclude: active GI bleeding or peptic ulcer within 6 months, other internal bleeding, prior intracranial hemorrhage, hereditary hemorrhagic disorder, acute pancreatitis, biliary obstruction, severe hypertension, allergy or idiosyncratic reaction to warfarin, and PT of greater than 16 seconds for at least 7 days. Pregnancy excludes. Expected Enrollment 65 patients will be entered over about 8 months. Per April 1985 activation amendment, this study will initially be piloted at a limited number of institutions. 20 patients will be entered initially. When 10 of these patients have completed Regimen B, the data will be reviewed; if toxicity is acceptable, the study will then be opened to group-wide participation and will accrue an additional 45-50 patients for a total of 65 entries. Outline Nonrandomized study. After 3 courses of Induction therapy, responders and those with stable disease enter Regimen B; those with objective evidence of response also receive prophylactic cranial irradiation on Regimen C concurrently and then return to Regimen A for 3 courses. Regimen A: Induction. 3-Drug Combination Chemotherapy plus Anticoagulant Therapy. ACE: Adriamycin, ADR, NSC-123127; Cyclophosphamide, CTX, NSC-26271; VP-16213, VP-16, NSC-141540; plus Warfarin, NSC-59813. Regimen B: 3-Drug Combination Chemotherapy plus Radiotherapy followed by 3-Drug Combination Chemotherapy plus Anticoagulant Therapy. PCE: cis-Platinum, CACP, NSC-119875; CTX; VP-16; plus involved-field chest irradiation using Co60 or accelerator beams with nominal energy of 4-10 MeV; followed by ACE; plus Warfarin. Regimen C: Radiotherapy. Prophylactic whole-brain irradiation using Co60 or accelerator beams of 4-10 MeV.Published Results Aisner J, Propert K, Perry M, et al.: Aggressive combination chemotherapy, chest and brain irradiation, and warfarin for the treatment of limited disease small cell lung cancer (SCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 6: A-707, 179, 1987. Trial Lead Organizations Cancer and Leukemia Group B
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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