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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Etoposide
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian cancer, Apatinib, Etoposide, Chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib + Etoposide

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate
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.

Secondary Outcome Measures

Progression-free survival (PFS)
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
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
Evaluation of adverse event rate according to CTCAE v4.03
Overall survival (OS)
Overall survival is defined as the duration from date of enrollment to the date of death from any cause.

Full Information

First Posted
August 3, 2016
Last Updated
December 3, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02867956
Brief Title
Apatinib and Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer
Official Title
A Phase II Study of Apatinib In Combination With Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 10, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
September 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian cancer, Apatinib, Etoposide, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apatinib + Etoposide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apatinib
Other Intervention Name(s)
Apatinib mesylate tablets, Aitan
Intervention Description
Apatinib 500mg daily, po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
VP-16
Intervention Description
Etoposide 50mg daily, po, day 1 to day 14, repeat every 21 days for 6 cycles
Primary Outcome Measure Information:
Title
Objective response rate
Description
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.
Time Frame
Up to three years
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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.
Time Frame
Up to three years
Title
Duration of Response
Description
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.
Time Frame
Up to three years
Title
Frequency and severity of adverse effects as defined by CTCAE version 4.03
Description
Evaluation of adverse event rate according to CTCAE v4.03
Time Frame
30 days after last dose
Title
Overall survival (OS)
Description
Overall survival is defined as the duration from date of enrollment to the date of death from any cause.
Time Frame
Up to three years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Huang, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
33012286
Citation
Huang X, Xie C, Tang J, He W, Yang F, Tian W, Li J, Yang Q, Shen J, Xia L, Lan C. Adipose tissue area as a predictor for the efficacy of apatinib in platinum-resistant ovarian cancer: an exploratory imaging biomarker analysis of the AEROC trial. BMC Med. 2020 Oct 5;18(1):267. doi: 10.1186/s12916-020-01733-4.
Results Reference
derived
PubMed Identifier
30082170
Citation
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.
Results Reference
derived

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

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