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Phase I/II Regional Chemotherapy with CACP/DCM for Advanced Head and Neck Cancer
Basic Trial Information
Objectives I. Determine the maximum tolerated dose (MTD) of cis-platinum given by short-term intra-arterial infusion through the side port of the Infusaid Pump. II. Determine the MTD of dichloromethotrexate given by continuous intra-arterial infusion in combination with cis-platinum. III. Determine the objective response rate and duration of response produced by cis-platinum/dichloromethotrexate in patients with advanced head and neck cancer. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with histologically proven, measurable squamous cell carcinoma primary in the head and neck who are not candidates for curative therapy with surgery or irradiation. Detectable tumor must be confined to the head and neck without distant metastases. The blood supply of the entire tumor volume must be derived from one external carotid artery and/or the thyrocervical trunk or both external carotid arteries. Patients must have objective evidence of disease progression following any prior therapy; those patients who received prior systemic therapy with methotrexate or cis-platinum are eligible but will be analyzed separately. Life expectancy must be at least 8 weeks, and the Karnofsky performance status must be at least 60. Patients over the age of 70 must have a Karnofsky performance status of at least 80 and must have no clinical evidence of CNS vascular disease. WBC and platelet counts must be at least 3,500/cumm and 150,000/cumm, respectively; liver and kidney function must be adequate. Patients must be candidates for general anesthesia for catheter implantation, and cardiac status must be adequate for receiving vigorous hydration (i.e., no congestive heart failure or recent myocardial infarction). Expected Enrollment The Phase I component of the study will be completed when 50% or more of the patients at the highest CACP dose achieve the MTD. Outline Nonrandomized study. 2-Drug Combination Chemotherapy. cis-Platinum, CACP, NSC-119875; Dichloromethotrexate, DCM, NSC-29630. Trial Lead Organizations Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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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