This phase II clinical trial studies the safety and effect of Gimatecan in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or peritoneal cancer. The chemotherapy will be given every four weeks.This study is a single-arm, multi-center research design.
The study had 3 phases: screening phase, treatment phase and follow-up phase. During the treatment phase, the drug will continue to be administered until the progression of disease, complete remission , unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Patients will receive gimatecan orally at the fixed dose level on day 1-5 every 4 weeks.
Objective response rate (ORR)
Percentage of patients with objective response assessed by best overall response (BOR) and independent review committee (IRC) of either complete response(CR) or partial remission(PR) will be reported.
Time frame: To evaluate objective response rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
Progression free survival (PFS)
The 2-year progression free survival of the whole group.
Time frame: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
Disease control rate (DCR)
will be reported.
Time frame: To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
Duration of Response (DoR)
The 2-year overall survival of the whole group.
Time frame: From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
Overall survival (OS)
The 2-year overall survival of the whole group.
Time frame: From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
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