Apatinib, Chemotherapy, Persistent Advanced Cervical Carcinoma, Recurrent Cervical Carcinoma, Targeted Therapy, Vascular Endothelial Growth Factor 2 Inhibitor
Conditions
Brief summary
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.
Interventions
DRUGChemotherapy plus apatinib
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.
Sponsors
Lei Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A combination of cisplatin, paclitaxel and apatinib would be given for all patients
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Female of 18-75 years old * Eastern Cooperative Oncology Group score 0-1 * Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure * An interval of 3 months or more since the fulfilling of last treatment * At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1 * Anticipative survival period of 3 months or more * Lab testing within reference ranges * With appropriate contraception * Provided consents of participating the trial
Exclusion criteria
* With a history of exposure to other antiangiogenic agents * With other malignancies within past 3 years * With vital complications * With uncontrolled hypertension despite of medical treatment * With severe cardiac disease, coagulation disorders, bleeding disorders, vascular diseases, deep venous thrombosis * With brain metastasis * With addiction to psychiatric medications or with mental disorders * With severe open trauma, fracture or major surgery with past 4 weeks * With disorders which would hamper the absorption of oral drugs, or with intestinal perforation or ileus with past 6 months * Urine protein ≥++, or 24 hr urine protein ≥1.0 g * With potential allergy or intolerance to study regimens * Not eligible for the study judged by researchers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | One year | The rates of complete and partial remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | One year | 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 |
| Overall survival | One year | 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. |
| Disease control rate | One year | The rates of complete and partial remission, and stable disease |
| Adverse event rates | One years | The rates of adverse events judged by Common Terminology Criteria for Adverse Events |
Countries
China
Outcome results
None listed