Back to resultsFirst-line Chemotherapy for Recurrent Cervical Cancer
Primary Purpose
Recurrent Cervical Carcinoma, Persistent Advanced Cervical Carcinoma, Chemotherapy
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chemotherapy plus apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Cervical Carcinoma
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
Sites / Locations
- Lei Li
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
The patients would accept the regimen of apatinib combined with cisplatin and paclitaxel
Outcomes
Primary Outcome Measures
Overall response rate
The rates of complete and partial remission
Secondary Outcome Measures
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
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.
Disease control rate
The rates of complete and partial remission, and stable disease
Adverse event rates
The rates of adverse events judged by Common Terminology Criteria for Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04188847
Brief Title
First-line Chemotherapy for Recurrent Cervical Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
February 6, 2022 (Actual)
Study Completion Date
March 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lei Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Cervical Carcinoma, Persistent Advanced Cervical Carcinoma, Chemotherapy, Vascular Endothelial Growth Factor 2 Inhibitor, Apatinib, Targeted Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
A combination of cisplatin, paclitaxel and apatinib would be given for all patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
The patients would accept the regimen of apatinib combined with cisplatin and paclitaxel
Intervention Type
Drug
Intervention Name(s)
Chemotherapy plus apatinib
Other Intervention Name(s)
First line chemotherapy plus apatinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall response rate
Description
The rates of complete and partial remission
Time Frame
One year
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
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
Time Frame
One year
Title
Overall survival
Description
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.
Time Frame
One year
Title
Disease control rate
Description
The rates of complete and partial remission, and stable disease
Time Frame
One year
Title
Adverse event rates
Description
The rates of adverse events judged by Common Terminology Criteria for Adverse Events
Time Frame
One years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Li, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lei Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual participant data will be available by public reports.
IPD Sharing Time Frame
Two year
IPD Sharing Access Criteria
Public reports
Learn more about this trial
First-line Chemotherapy for Recurrent Cervical Cancer
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