First-line Chemotherapy for Recurrent Cervical Cancer

NCT ID: NCT04188847

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-06
• Study Completion Date: 2022-03-13

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

The patients would accept the regimen of apatinib combined with cisplatin and paclitaxel

Group Type: EXPERIMENTAL

Chemotherapy plus apatinib

Intervention Type: DRUG

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.

Interventions

Chemotherapy 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.

Intervention Type: DRUG

Other Intervention Names

First line chemotherapy plus apatinib

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lei Li

OTHER

Sponsor Role: lead

Responsible Party

Lei Li

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Lei Li

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

REPACC-1

Identifier Type: -

Identifier Source: org_study_id