[Phase II clinical study of topotecan hydrochloride in patients with recurrent advanced ovarian cancer].
OBJECTIVE
Clinical studies showed there was no satisfying treatment of the patients with recurrent advanced ovarian cancer by using chemotherapy of combining platinum, and it is very important for oncologist to seek the second-line drugs to treat the patients with recurrent ovarian cancer. The current study was designed to evaluate the efficacy and toxicity of single agent Topotecan hydrochloride in the patients with recurrent advanced ovarian cancer.


METHODS
A total of 31 patients with recurrent ovarian cancer in a multiple centers clinical trial were treated with Topotecan 1.25 mg/m2 qd, i.v. inf. for 5 consecutive days every three weeks.


RESULTS
Among 21 evaluable cases, overall response rate was 33.33%. Among 29 ITT population the response rate was 24.14%, including 3 CR and 4 PR. Main side effects were hematologic toxicities, 31.0% patients and 37.5% courses developed Grade III-IV leukocytopenia, 20.7% patients and 14.3% courses developed Grade III-IV thrombocytopemia. Non-hematologic toxicities were mild.


CONCLUSIONS
Topotecan is effective for treating the patients with recurrent ovarian cancer who failed with platinum-based regimes.
Li
Jun-dong
JD
Cancer Center, Sun Yat-sen University, Guangzhou 510060, P. R. China.
Guan
Zhong-zhen
ZZ
Liu
Ji-hong
JH
Xin
Xiao-yan
XY
Cui
Yi
Y
Huang
Chang-jiang
CJ
Liu
Fu-yuan
FY
Song
Lei
L
Bian
Mei-lu
ML
Zhou
Qing-hua
QH
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D012008:Recurrence; D019772:Topotecan / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D019772:Topotecan