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.

• Authors: M Fabbro, L Gladieff, F Guichard, M El Demery, F Dalenc, C Kerr, M Delannes, D Paraiso, E Pujade-Lauraine, J-E Kurtz
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 117 Issue 2 Pg. 276-80 (May 2010) ISSN: 1095-6859 [Electronic] United States
• PMID: 20226502 (Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright (c) 2009 Elsevier Inc. All rights reserved.

Chemical References

• Irinotecan
• Cisplatin
• Camptothecin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Brachytherapy (adverse effects, methods)
• Camptothecin (administration & dosage, adverse effects, analogs & derivatives)
• Cisplatin (administration & dosage, adverse effects)
• Combined Modality Therapy
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Humans
• Irinotecan
• Middle Aged
• Neoplasm Staging
• Radiotherapy (adverse effects, methods)
• Uterine Cervical Neoplasms (drug therapy, pathology, radiotherapy)