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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

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Apatinib Drug: Etoposide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Apatinib In Combination With Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer
Actual Study Start Date : August 10, 2016
Actual Primary Completion Date : December 31, 2017
Estimated Study Completion Date : June 30, 2019


Arm Intervention/treatment
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.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867956


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Xin Huang, MD Sun Yat-sen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xin Huang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02867956     History of Changes
Other Study ID Numbers: B2016-020-01
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

Keywords provided by Xin Huang, Sun Yat-sen University:
Ovarian cancer
Apatinib
Etoposide
Chemotherapy

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Etoposide
Etoposide phosphate
Apatinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors