The response rate of traditional first-line chemotherapy for recurrent or persistent advanced cervical cancer was low. This single arm, open, phase II trial would recruit 37 eligible patients. A combination of cisplatin, paclitaxel and apatinib would be given for first 23 patients. If at least 13 patients achieved complete or partial remission, the same regimen would be given for rest patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
A combination of cisplatin, paclitaxel and apatinib would be given for all patients: * Cisplatin: 50 mg/m2 body surface area, on the first day, every 3 weeks. If the creatinine clearance rate was less than 40 ml/min, the cisplatin would be replace by carboplatin (area under ther curve = 5) * Paclitaxel: 50 mg/m2 body surface area, on the first day, every 3 weeks * Apatinib: 250 mg every day The total courses of cisplatin and paclitaxel would be no more than 6.
Lei Li
Beijing, Beijing Municipality, China
Overall response rate
The rates of complete and partial remission
Time frame: One year
Progression-free survival
The length of time during and after the treatment of the cancer, that a patient lives with the disease but it does not get worse
Time frame: One year
Overall survival
The length of time from either the date of diagnosis or the start of treatment for the cancer, that patients diagnosed with the disease are still alive.
Time frame: One year
Disease control rate
The rates of complete and partial remission, and stable disease
Time frame: One year
Adverse event rates
The rates of adverse events judged by Common Terminology Criteria for Adverse Events
Time frame: One years
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