Objective: The aim of this study was to determine tolerable doses and potential toxicities of taxol, administered weekly, with concomitant cisplatin and radiation therapy in advanced cervical cancer.
Methods: Patients with cervical cancer, either with evidence of distant metastatic disease at presentation or otherwise at high risk for recurrent disease, were eligible for this phase I study. Taxol was administered weekly as a 3-hr intravenous infusion in addition to the prescribed radiation therapy. The starting dose was 10 mg/m2/week and escalated at 10 mg/m2/week increments if tolerated by successive cohorts of three new patients. Cisplatin was given every 3 weeks at 50 mg/m2. Chemotherapy was continued until radiation was completed. For each patient quality of life was assessed weekly during therapy.
Results: Sixteen patients, undergoing a total of 102 cycles, have been enrolled. Dose escalation of taxol from 10 mg/m2/week to 50 mg/m2/week was well tolerated, with no significant change in quality of life during therapy. Two radiation fractions (0.5%) were delayed due to toxicity from this chemotherapy regimen. Of 102 cycles, 6 resulted in grade 2 and 1 in grade 3 neutropenia, and no patient developed >grade 2 anemia or thrombocytopenia. Three patients developed GI-related toxicities and 1 patient presented with urosepsis during treatment. There was a 93% response rate to this regimen, with 10 patients (63%) presently having no evidence of disease.
Conclusions: This study has demonstrated that up to 50 mg/m2/week of taxol is well tolerated in patients undergoing radiation therapy for advanced cervical cancer. A phase II trial will assist in determining the efficacy of taxol as a radiation sensitizer in these patients.
Copyright 1997 Academic Press.