Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

First-line Chemotherapy for Recurrent Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04188847
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

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
Recurrent Cervical Carcinoma Persistent Advanced Cervical Carcinoma Chemotherapy Vascular Endothelial Growth Factor 2 Inhibitor Apatinib Targeted Therapy Drug: Chemotherapy plus apatinib Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A 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 : December 6, 2019
Estimated Primary Completion Date : December 6, 2020
Estimated Study Completion Date : June 6, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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 Name: First line chemotherapy plus apatinib




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: One year ]
    The rates of complete and partial remission


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: One year ]
    The rates of complete and partial remission, and stable disease

  4. Adverse event rates [ Time Frame: One years ]
    The rates of adverse events judged by Common Terminology Criteria for Adverse Events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188847


Contacts
Layout table for location contacts
Contact: Lei Li, M.D. +8613911988831 lileigh@163.com

Locations
Layout table for location information
China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    008613911988831    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Investigators
Layout table for investigator information
Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital

Layout table for additonal information
Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04188847    
Other Study ID Numbers: REPACC-1
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The individual participant data will be available by public reports.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Two year
Access Criteria: Public reports

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Apatinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors