Phase I study of irinotecan and cisplatin in combination with pelvic radiotherapy in the treatment of locally advanced cervical cancer: A GINECO trial.

Abstract Purpose To define the recommended dose of the association of weekly irinotecan (Iri) and cisplatin (CP) with pelvic radiotherapy in Locally Advanced Cervical Cancer. Patients and methods Stage IB2-IV cervix cancer patients were treated with escalating doses of Iri starting from 30 mg/m 2 and a fixed dose of CP at 20 mg/m 2 , both weekly concomitantly with a 45-Gy pelvic irradiation. Results Fifteen patients entered the study, 6 at level 1 (Iri 30 mg/m 2 ), 3 at level 2 (Iri 40 mg/m 2 ) and 6 at intermediate dose (Iri 35 mg/m 2 ). Median age was 47 years (34-72), FIGO stage IB ( n =1), IIB ( n =7), III ( n =6), IVA ( n =1). The recommended dose was weekly Iri 35 mg/m 2 and CP 20 mg/m 2 . Dose limiting toxicities (grades 3–4) were diarrhea, abdominal pain, febrile neutropenia and fatigue. Conclusion In cervix cancer patients, radiosensitization with weekly cisplatin and irinotecan is feasible, and the recommended doses are cisplatin 20 mg/m 2 /week and irinotecan 35 mg/m 2 /week for future phase II studies.