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Apatinib and Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT02867956
Recruitment Status : Active, not recruiting
First Posted : August 16, 2016
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Xin Huang, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE August 3, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date June 26, 2019
Actual Study Start Date  ICMJE August 10, 2016
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
Objective response rate [ Time Frame: Up to three years ]
Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2016)
Objective response rate [ Time Frame: Up to three years ]
Objective response rate defined as confirmed complete response or partial response under RECIST 1.0 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.
Change History Complete list of historical versions of study NCT02867956 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Progression-free survival (PFS) [ Time Frame: Up to three years ]
    Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
  • Duration of Response [ Time Frame: Up to three years ]
    Duration of response was defined as the interval between the date of the first documented response by RECIST 1.1 to the date of first disease progression or death, whichever occurred earlier.
  • Frequency and severity of adverse effects as defined by CTCAE version 4.03 [ Time Frame: 30 days after last dose ]
    Evaluation of adverse event rate according to CTCAE v4.03
  • Overall survival (OS) [ Time Frame: Up to three years ]
    Overall survival is defined as the duration from date of enrollment to the date of death from any cause.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2016)
  • Progression-free survival (PFS) [ Time Frame: Up to three years ]
    Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
  • Duration of Response [ Time Frame: Up to three years ]
    Duration of response was defined as the interval between the date of the first documented response by RECIST to the date of first disease progression or death, whichever occurred earlier.
  • Frequency and severity of adverse effects as defined by CTCAE version 4.0 [ Time Frame: 30 days after last dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Apatinib and Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer
Official Title  ICMJE A Phase II Study of Apatinib In Combination With Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer
Brief Summary The purpose of the study is to evaluate the efficacy and toxicity of apatinib in patients with platinum resistant or refractory ovarian cancer when combined with etoposide.
Detailed Description Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. In most cases, the disease is diagnosed at an advanced stage and approximately 75% of patients will eventually experience disease recurrence. However, the overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. Therefore, it is important to seek alternative agent that can improve the outcome. Apatinib is a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor and it has been approved for the treatment of advanced gastric cancer. The preclinical studies suggest apatinib may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug apatinib when combined with a standard treatment, etoposide, for patients with platinum resistant or refractory ovarian cancer.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: Apatinib
    Apatinib 500mg daily, po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.
    Other Names:
    • Apatinib mesylate tablets
    • Aitan
  • Drug: Etoposide
    Etoposide 50mg daily, po, day 1 to day 14, repeat every 21 days for 6 cycles
    Other Name: VP-16
Study Arms  ICMJE Experimental: Apatinib + Etoposide

Apatinib 500mg daily, po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.

Etoposide 50mg daily, po, day 1 to day 14, repeat every 21 days for 6 cycles.

Interventions:
  • Drug: Apatinib
  • Drug: Etoposide
Publications * Lan CY, Wang Y, Xiong Y, Li JD, Shen JX, Li YF, Zheng M, Zhang YN, Feng YL, Liu Q, Huang HQ, Huang X. Apatinib combined with oral etoposide in patients with platinum-resistant or platinum-refractory ovarian cancer (AEROC): a phase 2, single-arm, prospective study. Lancet Oncol. 2018 Sep;19(9):1239-1246. doi: 10.1016/S1470-2045(18)30349-8. Epub 2018 Aug 3. Erratum in: Lancet Oncol. 2018 Sep;19(9):e440.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2018)
35
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2016)
68
Estimated Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
  • Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)
  • At least treated with one line of platinum-based chemotherapy
  • Female, age ≥18 years and ≤70 years, signed informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version
  • Patients must have a life expectancy of at least 3 months.
  • Patients must have adequate organ function as defined by the following criteria:

    • White blood cell count ≥ 3 x 10^9/L, Absolute neutrophil count (ANC) (≥ 1.5 x 10^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 70 x 10^9/L
    • Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2 x ULN
    • Serum creatinine ≤ 1 x ULN

Exclusion Criteria:

  • Had prior exposure to apatinib or has known allegies to any of the excipients.
  • History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
  • Patients with QT interval prolongation
  • Serious, non-healing wound, active ulcer, bowel obstruction.
  • History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1
  • Evidence of bleeding diathesis or coagulopathy
  • Inadequately controlled hypertension
  • Major surgical procedure within 28 days prior to Day 1
  • Symptomatic central nervous system (CNS) metastasis
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02867956
Other Study ID Numbers  ICMJE B2016-020-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Responsible Party Xin Huang, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xin Huang, MD Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP