Status:
UNKNOWN
Apatinib Plus Etoposide Versus Etoposide Alone for Platinum-resistant Recurrent Ovarian Cancer
Lead Sponsor:
Yang Zhijun
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 w...
Detailed Description
It is a randomized controlled trial, the aim is to see the efficacy and safety of Apatinib plus Etoposide treating platinum-resistant ovarian cancer. The main primary end point is DCR (disease control...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- "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)
- Patients with a history of psychiatric abuse and who can not quit or have mental disorders
- Patients who participated in other drug clinical trials within 4 weeks
- Patients who received VEGFR inhibitors such as sorafenib and sunitinib treatment
- Patients who received Etoposide treatment
- According to the researcher's judgment, there are serious illnesses that endanger the patient's safety or affect the completion of the study
- Patients that are not suitable for this trial in the investigator's opinions.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03298074
Start Date
October 1 2017
End Date
April 1 2019
Last Update
September 29 2017
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