Phase I trial of concomitant vinorelbine, cisplatin, and pelvic irradiation in cervical carcinoma and other advanced pelvic malignancies

Objective. The aim of this study was to determine the feasibility and toxicity of concomitant vinorelbine, paclitaxel, and pelvic radiation therapy (RT) in patients with advanced cervical cancer and other pelvic malignancies. Methods. Eligible patients included those with large or locally advanced cervical cancer. In addition, patients with other ad- vanced gynecologic malignancies were eligible. In part I, vinorel- bine was administered as a single agent during pelvic RT at a starting dose of 10 mg/m 2 /week with subsequent cohorts being 2 /week were well tolerated, with the primary toxicity being hematologic. RT was delayed in only 1 patient due to acute hematologic toxicity. In contrast, the combination of paclitaxel, vinorelbine, and pelvic RT was not well tolerated. Five of 6 patients (83%) experienced grade >2 leukopenia, with 2 patients missing >1 cycle of chemotherapy. Moreover, RT was delayed for 1 week in 2 of 6 patients (33%). Conclusions. Concomitant pelvic RT and vinorelbine with doses to 25 mg/m 2 /week is well tolerated. The addition of paclitaxel to this combination is associated with significant hematologic toxicity and is thus not a feasible approach. © 2001 Academic Press