A phase I/II study of carboplatin and paclitaxel in patients with epithelial ovarian cancer.
BACKGROUND
This study was conducted to investigate the recommended dose of paclitaxel for use in combination with a fixed dose of carboplatin and to evaluate the toxicity and efficacy of carboplatin-paclitaxel combination chemotherapy in patients with epithelial ovarian cancer.


METHODS
One hundred and ten patients were enrolled in the Phase I/II study and 97 patients were evaluated for further analysis, excluding 13 ineligible patients or patients with infringement of protocol: 15 patients for the Phase I and 82 for the Phase II study. In the Phase I trial, we studied dose escalation using a carboplatin dose of AUC 5 and paclitaxel levels of 150, 175 and 200 mg/m(2). The grades of toxicity of the regimen of all patients enrolled in the Phase II study (n = 82), the progression-free survival time (PFS) of optimal-debulked patients and complete responders (n = 62) and the response rate of suboptimal-debulked patients (n = 39) were investigated.


RESULTS
After observing grade 4 neutropenia in four of six patients in the paclitaxel 200 mg/m(2) administration group, we chose 175 mg/m(2) as the recommended dose of paclitaxel in this regimen. At this dose, the median of PFS and response rate were 432 days (range, 19-907 days) and 66.7%, respectively.


CONCLUSIONS
Combination chemotherapy using paclitaxel 175 mg/m(2) and carboplatin AUC 5 is very well tolerated and highly effective for the treatment of ovarian cancer.
Yamamoto
Ritsu
R
Department of Obstetrics and Gynecology, Hokkaido University School of Medicine, Sapporo, Japan. rityam@med.hokudai.ac.jp
Minobe
Shinichiro
S
Kaneuchi
Masanori
M
Sakuragi
Noriaki
N
Fujimoto
Seiichiro
S
Ishizaki
Yoshiaki
Y
Domon
Hiroka
H
Hareyama
Hitoshi
H
Sato
Chikara
C
Fujino
Takahumi
T
Kawaguchi
Isao
I
Yamaguchi
Tatsumi
T
Fujimoto
Toshio
T
Yoshiaki
Ken
K
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002277:Carcinoma / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage
D016190:Carboplatin; D017239:Paclitaxel