search
Back to results

Apatinib Plus Etoposide Versus Etoposide Alone for Platinum-resistant Recurrent Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Apatinib
Etoposide
Sponsored by
Yang Zhijun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring platinum-resistant, recurrent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ECOG PS：0-2 points
  • Platinum-resistant recurrent ovarian cancer patients with measurable recurrent focus
  • The damage caused by other treatment has been restored (NCI-CTCAE 4.0 Graded ≤ 1 level), Other cytotoxic drugs treatment, radiotherapy or surgery≥ 4 week; EGFR TKI treatment ≥ 2 week

  • Baseline routine blood test and biochemical indicators meet the following criteria:

    • Hemoglobin ≥ 90g / L
    • Neutrophil absolute count (ANC) ≥ 1.5 × 109 / L
    • Platelets ≥80 × 109 / L
    • ALT, AST ≤ 2.5 × ULN or 5 × ULN (with liver metastases)
    • Total Serum bilirubin ≤ 1.5 × ULN
    • Serum creatinine≤1.5×ULN or endogenous creatinine clearance ≥ 45ml/min (according to Cockcroft-Gault formula);
  • No blood and blood products transfusion in 14 Days
  • Expected survival time≥3 month;
  • Subjects volunteer to join the study, sign informed consent, cooperate with follow-up.

Exclusion Criteria:

  • "biochemical recurrence " ovarian cancer patients
  • Patients allergy to apatinib, etoposide and / or its excipients
  • Patients with high blood pressure and who can not be reduced to normal range by antihypertensive therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg), with grade I coronary heart disease, grade I arrhythmia (including QTc prolongation > 470 ms)
  • According to NYHA standard, grade Ⅲ-Ⅳ heart failure, or cardiac color Doppler ultrasound examination shows left ventricular ejection fraction (LVEF) <50%
  • Urine protein positive patients
  • With a variety of factors that affect oral medication (such as can not swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.)
  • Patients with definite gastrointestinal bleeding tendencies, including the following: localized ulcer lesions, and fecal occult blood (++); 2 months with black stool, hematemesis history
  • Patients with coagulation dysfunction (INR> 1.5, APTT> 1.5 ULN), bleeding tendency
  • Existing hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.)
  • Long untreated wound or fracture;major surgery or severe traumatic injury in 4 weeks, fracture or ulcer
  • Accompanied by abdominal fistula, gastrointestinal perforation or abdominal abscess; active hepatitis B virus or hepatitis C patients
  • Active brain metastases, cancer meningitis, spinal cord compression patients, Imaging CT or MRI examination found the brain or pia mater disease,( brain metastases patients who has complete treatment 21 days before and has stable symptoms can be enrolled , but the need for transcranial MRI, CT or intravenous angiography evaluation confirmed as no cerebral hemorrhage symptoms)
  • Imaging (CT or MRI) shows tumor lesions from large vessels ≤ 5 mm, or lesions invade the Local large blood vessels
  • Lactating women
  • Patients with other malignancies in 5 years (except for cured skin basal cell carcinoma and in situ ovarian cancer)
  • Patients with a history of psychiatric abuse and who can not quit or have mental disorders
  • Patients who participated in other drug clinical trials within 4 weeks
  • Patients who received VEGFR inhibitors such as sorafenib and sunitinib treatment
  • Patients who received Etoposide treatment
  • According to the researcher's judgment, there are serious illnesses that endanger the patient's safety or affect the completion of the study
  • Patients that are not suitable for this trial in the investigator's opinions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Apatinib plus Etoposide

    Etoposide

    Arm Description

    Apatinib,500mg,PO.QD, continuous administration Etoposide,100mg, PO.QD，D1-D10, Q3W

    Etoposide,100mg, PO.QD，D1-D10, Q3W

    Outcomes

    Primary Outcome Measures

    Disease Control Rate
    the proportion of patients who had a best response rating of complete response, partial response, or stable disease

    Secondary Outcome Measures

    Duration of Response
    the time course from the first time tumor assessed as CR or PR to the first time tumor assessed as progressive disease or death
    Overall Survival
    From the beginning of randomization to the cause of death for any reason
    Time to Progression
    From randomization to the onset of disease progression or death

    Full Information

    First Posted
    September 27, 2017
    Last Updated
    September 28, 2017
    Sponsor
    Yang Zhijun
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03298074
    Brief Title
    Apatinib Plus Etoposide Versus Etoposide Alone for Platinum-resistant Recurrent Ovarian Cancer
    Official Title
    Apatinib Plus Etoposide Versus Etoposide Alone for Platinum-resistant Recurrent Ovarian Cancer: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2017 (Anticipated)
    Primary Completion Date
    October 2018 (Anticipated)
    Study Completion Date
    April 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yang Zhijun

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    It is a prospective multi-center trial, platinum-resistant ovarian cancer patients will be randomized in two groups, one group will be treated with Apatinib plus Etoposide, the other will be treated with Etoposide alone. It is aimed to see the efficacy and safety of Apatinib plus Etoposide for the platinum-resistant ovarian cancer patients
    Detailed Description
    It is a randomized controlled trial, the aim is to see the efficacy and safety of Apatinib plus Etoposide treating platinum-resistant ovarian cancer. The main primary end point is DCR (disease control rate), the secondary endpoint is Duration of response（DOR），overall survival (OS), time to progression (TTP)，quality of life (QoL, according to EORTC QLQ-C30).The key safety indicators include the patients' vital signs, laboratory indicators, adverse events(AE),serious adverse events. The data collection duration is from the day ICF assigned to the day(30 days after the end of the last medication).From the day ICF signed to the end of the study, all adverse events were recorded in the CRF. The severity of the adverse events will be evaluated according to the NCI CTCAE 4.0 standard.Each patient will receive a planned visit and specific data at different points will be recorded in the visit. The patients will be followed up after quitting the trial because of disease progression or intolerance. The following parameters were recorded during follow-up: disease recurrence,metastasis,death time,SAE occurred during the study; survival (available with telephone follow-up, record required). Adverse events that have not been recovered when the drug is discontinued should be tracked and finalized. All patients should undergo a 30-day follow-up after the last medication to find any new adverse events. All cases should be recorded carefully and completely, the investigator should be responsible for the authenticity of the center's data. During the clinical trial, the inspector should send the CRF to the data management unit (in batches), the data administrator will carry out the independent double entry, and carry out the double verification. The trial as an exploratory test, using a small sample comparison, the test plans to enroll a total of 60 cases. The statistical analysis plan includes case analysis,demographic data and baseline analysis,efficacy analysis and safety analysis.All statistical tests will be performed on both sides, the difference between the tests was considered statistically significant with a P value less than or equal to 0.05,

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Cancer
    Keywords
    platinum-resistant, recurrent

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Apatinib plus Etoposide
    Arm Type
    Experimental
    Arm Description
    Apatinib,500mg,PO.QD, continuous administration Etoposide,100mg, PO.QD，D1-D10, Q3W
    Arm Title
    Etoposide
    Arm Type
    Active Comparator
    Arm Description
    Etoposide,100mg, PO.QD，D1-D10, Q3W
    Intervention Type
    Drug
    Intervention Name(s)
    Apatinib
    Other Intervention Name(s)
    Aitan
    Intervention Description
    Apatinib, 500mg,po qd for continuous administration
    Intervention Type
    Drug
    Intervention Name(s)
    Etoposide
    Intervention Description
    Etoposide,100mg, PO.QD，D1-D10, Q3W
    Primary Outcome Measure Information:
    Title
    Disease Control Rate
    Description
    the proportion of patients who had a best response rating of complete response, partial response, or stable disease
    Time Frame
    through study completion, an average of 1.5 years
    Secondary Outcome Measure Information:
    Title
    Duration of Response
    Description
    the time course from the first time tumor assessed as CR or PR to the first time tumor assessed as progressive disease or death
    Time Frame
    through study completion, an average of 1.5 years
    Title
    Overall Survival
    Description
    From the beginning of randomization to the cause of death for any reason
    Time Frame
    through study completion, an average of 3 years
    Title
    Time to Progression
    Description
    From randomization to the onset of disease progression or death
    Time Frame
    through study completion, an average of 1.5 years

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    female patient with recurrent ovarian cancer
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ECOG PS：0-2 points Platinum-resistant recurrent ovarian cancer patients with measurable recurrent focus The damage caused by other treatment has been restored (NCI-CTCAE 4.0 Graded ≤ 1 level), Other cytotoxic drugs treatment, radiotherapy or surgery≥ 4 week; EGFR TKI treatment ≥ 2 week Baseline routine blood test and biochemical indicators meet the following criteria: Hemoglobin ≥ 90g / L Neutrophil absolute count (ANC) ≥ 1.5 × 109 / L Platelets ≥80 × 109 / L ALT, AST ≤ 2.5 × ULN or 5 × ULN (with liver metastases) Total Serum bilirubin ≤ 1.5 × ULN Serum creatinine≤1.5×ULN or endogenous creatinine clearance ≥ 45ml/min (according to Cockcroft-Gault formula); No blood and blood products transfusion in 14 Days Expected survival time≥3 month; Subjects volunteer to join the study, sign informed consent, cooperate with follow-up. Exclusion Criteria: "biochemical recurrence " ovarian cancer patients Patients allergy to apatinib, etoposide and / or its excipients Patients with high blood pressure and who can not be reduced to normal range by antihypertensive therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg), with grade I coronary heart disease, grade I arrhythmia (including QTc prolongation > 470 ms) According to NYHA standard, grade Ⅲ-Ⅳ heart failure, or cardiac color Doppler ultrasound examination shows left ventricular ejection fraction (LVEF) <50% Urine protein positive patients With a variety of factors that affect oral medication (such as can not swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.) Patients with definite gastrointestinal bleeding tendencies, including the following: localized ulcer lesions, and fecal occult blood (++); 2 months with black stool, hematemesis history Patients with coagulation dysfunction (INR> 1.5, APTT> 1.5 ULN), bleeding tendency Existing hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.) Long untreated wound or fracture;major surgery or severe traumatic injury in 4 weeks, fracture or ulcer Accompanied by abdominal fistula, gastrointestinal perforation or abdominal abscess; active hepatitis B virus or hepatitis C patients Active brain metastases, cancer meningitis, spinal cord compression patients, Imaging CT or MRI examination found the brain or pia mater disease,( brain metastases patients who has complete treatment 21 days before and has stable symptoms can be enrolled , but the need for transcranial MRI, CT or intravenous angiography evaluation confirmed as no cerebral hemorrhage symptoms) Imaging (CT or MRI) shows tumor lesions from large vessels ≤ 5 mm, or lesions invade the Local large blood vessels Lactating women Patients with other malignancies in 5 years (except for cured skin basal cell carcinoma and in situ ovarian cancer) Patients with a history of psychiatric abuse and who can not quit or have mental disorders Patients who participated in other drug clinical trials within 4 weeks Patients who received VEGFR inhibitors such as sorafenib and sunitinib treatment Patients who received Etoposide treatment According to the researcher's judgment, there are serious illnesses that endanger the patient's safety or affect the completion of the study Patients that are not suitable for this trial in the investigator's opinions.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhijun Yang
    Phone
    8618994127461
    Email
    18994127461@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhijun Yang
    Organizational Affiliation
    Affiliated Cancer Hospital & Institute of Guangzhou Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Apatinib Plus Etoposide Versus Etoposide Alone for Platinum-resistant Recurrent Ovarian Cancer

    We'll reach out to this number within 24 hrs