First-line Chemotherapy for Recurrent Cervical Cancer

NCT04188847 | Completed Phase 2 DMC

• 1 other identifier: REPACC-1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  The rates of complete and partial remission

  One year

Secondary Outcomes (4)

• Progression-free survival

  One year

• Overall survival

  One year

• Disease control rate

  One year

• Adverse event rates

  One years

Study Arms (1)

Study group

EXPERIMENTAL

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

Drug: Chemotherapy plus apatinib

Interventions

Chemotherapy plus apatinib 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.

Also known as: First line chemotherapy plus apatinib

Study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Drug Therapy; apatinib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: A combination of cisplatin, paclitaxel and apatinib would be given for all patients

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: December 6, 2019
• Primary Completion: February 6, 2022
• Study Completion: March 13, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Two year
• Access Criteria: Public reports

Locations

CN (1)