First-line Chemotherapy for Recurrent Cervical Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Apatinib Combined With Cisplatin and Paclitaxel as First-line Chemotherapy for Recurrent or Persistent Advanced Cervical Cancer: A Single Arm, Single Center, Open, Phase II Trial

Conditions
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Persistent Advanced Cervical Carcinoma, Chemotherapy, Recurrent Cervical Carcinoma, Vascular Endothelial Growth Factor 2 Inhibitor, Apatinib, Targeted Therapy

Intervention / Treatment
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* Drug: Chemotherapy plus apatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A combination of cisplatin, paclitaxel and apatinib would be given for all patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>The patients would accept the regimen of apatinib combined with cisplatin and paclitaxel | Drug: Chemotherapy plus apatinib<br>* 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.<br>* Other names: First line chemotherapy plus apatinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | The rates of complete and partial remission | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | One year | 
| Disease control rate | The rates of complete and partial remission, and stable disease | One year | 
| Adverse event rates | The rates of adverse events judged by Common Terminology Criteria for Adverse Events | One years |