Weekly carboplatin and docetaxel for locally advanced primary and recurrent cervical cancer: a phase I study.
OBJECTIVE
The aim of this study was to determine the dose-limiting toxicities (DLTs) and maximum tolerated doses (MTDs) of a docetaxel-carboplatin regimen in patients with locally advanced cervical cancer (LACC) or recurrent cervical cancer. The regimen was administered weekly, with a maximum of 12 courses.


METHODS
Twenty patients were treated with with a total of 145 cycles of weekly carboplatin and docetaxel. The starting dose of docetaxel was 25 mg/m(2) with increments of 5 mg/m(2) until a final dose of 35 mg/m(2) was reached. Dose-escalation of docetaxel was followed by carboplatin at AUC 2, AUC 2.5, and AUC 3, respectively. Defined dose-limiting toxicities were WHO grade (G) 3 hematotoxicity, G4 mucositis, and G2 neurotoxicity. The response status of the patients was assessed using the common ECOG response criteria.


RESULTS
Two of four patients developed a DLT at dose level 4. Nonhematological toxicity was generally mild, except for ubiquitous complete alopecia. The MTD was reached at docetaxel 35 mg/m(2) and carboplatin AUC 2 mg/mL.min. The overall response rate was 65% in the entire group of evaluable patients and 77% in patients with primary LACC, with two cases of pathological complete response.


CONCLUSIONS
This dose-dense regimen was well-tolerated and could be administered on an outpatient basis.
Rein
D T
DT
Department of Gynecology and Obstetrics, University of Düsseldorf, Postfach 10 10 07, 40001 Düsseldorf, Germany. rein@med.uni-duesseldorf.de
Kurbacher
C M
CM
Breidenbach
M
M
Schöndorf
T
T
Schmidt
T
T
König
E
E
Göhring
U-J
UJ
Blohmer
J-U
JU
Mallmann
P
P
D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D043823:Taxoids; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin; D017239:Paclitaxel