Apatinib and Chemotherapy Sequential Treatment With Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

A Phase II Clinical Trial Study on Apatinib and Chemotherapy Sequential Treatment With Advanced Metastatic Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03029013
• Other study ID #: ACSTCC
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2017
• Last updated: January 19, 2017
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: January 2017
• Source: Third Military Medical University
• Contact: Jin Feng, MD
• Phone: 86-13908315698
• Email: wanggedaping[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is the single arm and single center clinical trials，We conduct the phase II clinical trial to further explore the efficacy and safety of Apatinib and chemotherapy sequential treatment with advanced recurrence of metastatic cervical cancer

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• The pathological diagnosis of recurrent or metastatic cervical cancer;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1;

• Life expectancy of more than 3months;

• With normal marrow, liver and renal function:

• blood routine examination :HB=90g/L,ANC =1.5×10*9/L,PLT=80×10*9/L;

• Biochemical examination: total bilirubin (TBil) of =1.5 upper normal limitation (UNL),alanine aminotransferase (ALT) and aspartate aminotransferase (AST) of =2.5 UNL or =5 UNL ,acreatinine (Cr) of = 1.25 UNL; creatinine clearance rate = 45ml/min (Cockcroft-Gault);

• With written informed consent signed voluntarily by patients themselves .

• With good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion Criteria:

• Uncontrolled hypertension

• Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias

• With abnormal coagulation function, bleeding tendency or treating with thrombolysis and anticoagulation

• History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding ulcer, occult blood = (++), and vasculitis) =< 3 months prior to randomization;

• uncured the wound or fracture

• Centrally located tumors of local invasion of major blood vessels, or Researchers think that patients may invade the important blood vessels and cause fatal bleeding (CT or MRI);

• Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction);

• Urine protein >++, or urine protein in 24 hours> 1.0g

• Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment

• History of uncontrolled psychotropic drug abuse or mental disorders;

• Prior VEGFR inhibitor treatment ;

• Other malignancy within Before or at the same time other than basal cell skin cancer, or carcinoma in situ of the cervix;

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Apatinib
Apatinib, 250 mg qd,po,after 7 days , paclitaxel (135-175 mg/m2) and platinum two drug standard chemotherapy, 21 days as a treatment cycle,during the chemotherapy of 7-21 days continue to offer the Apatinib. without disease progress, after 4 chemotherapy cycles, patients continue to accept the Apatinib maintenance treatment.

Locations

Country	Name	City	State
China	Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		24 months
Secondary	overall survival		24 months