Phase I study of irinotecan and cisplatin in combination with pelvic radiotherapy in the treatment of locally advanced cervical cancer: A GINECO trial.
OBJECTIVE
To define the recommended dose of the association of weekly irinotecan (Iri) and cisplatin (CP) with pelvic radiotherapy in Locally Advanced Cervical Cancer.


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.


CONCLUSIONS
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.
Centre de Lutte contre le Cancer Val d'Aurelle, Montpellier, France.
M
M
Fabbro
L
L
Gladieff
F
F
Guichard
M
M
El Demery
F
F
Dalenc
C
C
Kerr
M
M
Delannes
D
D
Paraiso
E
E
Pujade-Lauraine
J-E
JE
Kurtz
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008875:Middle Aged; D009367:Neoplasm Staging; D011878:Radiotherapy / Q000009:adverse effects / Q000379:methods; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*
D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin