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First-line Chemotherapy for Recurrent Cervical Cancer

Sponsor
Lei Li (Other)
Overall Status
Completed
CT.gov ID
NCT04188847
Collaborator
(none)
37
Enrollment
1
Location
1
Arm
27.2
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chemotherapy plus apatinib
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A combination of cisplatin, paclitaxel and apatinib would be given for all patientsA combination of cisplatin, paclitaxel and apatinib would be given for all patients
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 6, 2019
Actual Primary Completion Date :
Feb 6, 2022
Actual Study Completion Date :
Mar 13, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group

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

Drug: 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.
Other Names:
  • First line chemotherapy plus apatinib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall response rate [One year]

      The rates of complete and partial remission

    Secondary Outcome Measures

    1. 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

    2. 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.

    3. Disease control rate [One year]

      The rates of complete and partial remission, and stable disease

    4. Adverse event rates [One years]

      The rates of adverse events judged by Common Terminology Criteria for Adverse Events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lei Li Beijing Beijing China 100730

    Sponsors and Collaborators

    • Lei Li

    Investigators

    • Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lei Li, Professor, Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT04188847
    Other Study ID Numbers:
    • REPACC-1
    First Posted:
    Dec 6, 2019
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Uterine Cervical Neoplasms
    Recurrence
    Apatinib

    Study Results

    No Results Posted as of Mar 15, 2022