A phase I/II study of docetaxel and gemcitabine combination for chemotherapy-resistant ovarian cancer.
BACKGROUND
A phase I/II study of docetaxel (DOC) and gemcitabine (GEM) combination for treatment-resistant ovarian cancer (OC) was conducted.


METHODS
Eligible patients exhibited recurrent OC within 12 months after initial treatment, or after more than 2 chemotherapy regimens. Planned dose levels (DL) were as follows: DOC 70 mg/m(2), GEM 800 mg/m(2) (DL1); DOC 70 mg/m(2), GEM 1000 mg/m(2) (DL2). DOC was administered on day 1 combined with GEM on days 1 and 8 every 3 weeks. Adverse events were assessed by NCI-CTC2.0J. Response was evaluated by RECIST or Rustin's criteria.


RESULTS
The recommended dose was DL1. For all enrolled patients, the median interval from last chemotherapy was 2.5 (1-11) months and 32 patients were assessable for response. One complete response, 6 partial responses and 6 stable disease were noted. Median time to progression was 4.8 months. Toxicities were mainly hematological and manageable.


CONCLUSIONS
This combination could be an acceptable treatment option before palliation.
Itani
Yoshio
Y
Nara Prefectural Nara Hospital Ob & Gyn. 1-30-1 Hiramatsucho, Narashi Nara 631-0846, Japan. nuages@m3.kcn.ne.jp
Hosokawa
Kenichi
K
Ito
Kimihiko
K
Takeuchi
Satoshi
S
Tabata
Tsutomu
T
Tsubamoto
Hiroshi
H
Fujita
Hiroyuki
H
Akiyama
Minoru
M
Adachi
Susumu
S
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D043823:Taxoids / Q000008:administration & dosage; D000093542:Gemcitabine
D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine