First-line Chemotherapy for Recurrent Cervical Cancer

Chemotherapy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188847
• Other study ID #: REPACC-1
• Status: Completed
• Phase: Phase 2
• Start date: December 6, 2019
• Est. completion date: March 13, 2022

Study information

• Verified date: March 2022
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 13, 2022
• Est. primary completion date: February 6, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apatinib
• Carcinoma
• Chemotherapy
• Persistent Advanced Cervical Carcinoma
• Recurrent Cervical Carcinoma
• Targeted Therapy
• Uterine Cervical Neoplasms
• Vascular Endothelial Growth Factor 2 Inhibitor

Intervention

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.

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	The rates of complete and partial remission	One year
Secondary	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	One year
Secondary	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.	One year
Secondary	Disease control rate	The rates of complete and partial remission, and stable disease	One year
Secondary	Adverse event rates	The rates of adverse events judged by Common Terminology Criteria for Adverse Events	One years