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

NCT ID: NCT02867956

Last Updated: 2020-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-10
• Study Completion Date: 2019-09-10

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.

Conditions

Ovarian Cancer

Keywords

Ovarian cancer; Apatinib; Etoposide; Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

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

Etoposide

Intervention Type: DRUG

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

Interventions

Apatinib

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

Intervention Type: DRUG

Etoposide

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

Intervention Type: DRUG

Other Intervention Names

Apatinib mesylate tablets; Aitan; VP-16

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xin Huang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33012286 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30082170 (View on PubMed)

Other Identifiers

B2016-020-01

Identifier Type: -

Identifier Source: org_study_id