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

NCT03298074 | Unknown Phase 2

• 1 other identifier: HRGX-001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Ovarian Cancer

Keywords

platinum-resistant; recurrent

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate

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

  through study completion, an average of 1.5 years

Secondary Outcomes (3)

• Duration of Response

  through study completion, an average of 1.5 years

• Overall Survival

  through study completion, an average of 3 years

• Time to Progression

  through study completion, an average of 1.5 years

Study Arms (2)

Apatinib plus Etoposide

EXPERIMENTAL

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

Drug: Apatinib; Drug: Etoposide

Etoposide

ACTIVE COMPARATOR

Etoposide,100mg, PO.QD，D1-D10, Q3W

Drug: Etoposide

Interventions

Apatinib DRUG

Apatinib, 500mg,po qd for continuous administration

Also known as: Aitan

Apatinib plus Etoposide

Etoposide DRUG

Etoposide,100mg, PO.QD，D1-D10, Q3W

Apatinib plus Etoposide; Etoposide

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female patient with recurrent ovarian cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• "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)

Sponsors & Collaborators

• Yang Zhijun: lead

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence

Interventions

apatinib; Etoposide

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Zhijun Yang

  Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhijun Yang

CONTACT

8618994127461; 18994127461@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: September 29, 2017
• Study Start: October 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: April 1, 2019
• Last Updated: September 29, 2017

Record last verified: 2017-09