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Objective. To evaluate the combination of cisplatin and irinotecan as first-l ine treatment of patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix. Methods. Patients with no prior treatment for metastati c disease, presence of measurable tumors, performance status of 0 or 1, and adeq uate bone marrow, renal, and hepatic functions were potentially eligible for thi s trial. Cisplatin and irinotecan were givenweekly at starting doses of 25 and 6 5mg/m2, respectively, for three con secutive weeks. Cycles were to be repeated every 28 days with dose adjustments as required. Patient accrual was based on a two-stage design with at least sev en responses out of 28 patients in the first stage required to proceed to a seco nd stage of accrual seeking a response rate of 40%or better. Results. Of 34 pat ients entered onto the study, 31 were eligible and 27 were evaluable for respons e. Ten had received prior chemoradiation containing cisplatin. Among the five (t wo complete and three partial) observed responses, two were in the subset of pat ients who had received prior chemoradiation. This level of activity was deemed i nsufficient to warrant a second stage of accrual. Predominant toxicities were my elosuppression and gastroin-testinal symptoms, although six patients experience d none of these adverse effects. Conclusion. At these doses, weekly cisplatin an d irinotecan failed to demonstrate sufficient activity to undertake a phase III study. Although not apparent in this study, prior chemoradiation may affect resp onse to platinumbased combinations and its impact should be considered in the de sign of future trials.
Objective. To evaluate the combination of cisplatin and irinotecan as first-l ine treatment of patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix. Methods. Patients with no prior treatment for metastati c disease, presence of measurable tumors, performance status of 0 or 1, and adeq uate bone marrow, renal, and hepatic functions were potentially eligible for thi s trial. Cisplatin and irinotecan were given weekly at starting doses of 25 and 6 5 mg / m2, respectively, for three con secutive weeks. Cycles were to be repeated for 28 days with dose adjustments as required. Patient accrual was based on a two-stage design with at least sev en responses out of 28 patients in the first stage required to proceed to a seco nd stage of accrual seeking a response Of the 34 pat ients entered onto the study, 31 were eligible and 27 were evaluable for respons e. Ten had received prior chemoradiation containing cisplatin. Among the five (tw This complete level of activity was deemed i nsufficient to warrant a second stage of accrual. Predominant toxicities were my elosuppression and gastroin-testinal symptoms, Although six patients experience d none of these adverse effects. Conclusion. At these doses, weekly cisplatin an d irinotecan failed to demonstrate sufficient activity to undertake a phase III study. Although not apparent in this study, prior chemoradiation may affect resp onse to platinumbased combinations and its impact should be considered as the de sign of future trials.