Status:
COMPLETED
Sunitinib® in Patients With Recurrent Ovarian Clear Cell Carcinoma
Lead Sponsor:
Cathay General Hospital
Conditions:
Ovarian Cancer
Adverse Effects
Eligibility:
FEMALE
20-80 years
Phase:
PHASE2
Brief Summary
Patients with early and advanced stages of epithelial ovarian cancer are treated with postoperative systemic chemotherapy after appropriate surgical staging and cytoreductive surgery. For ovarian canc...
Detailed Description
Ovarian cancer is the 10th leading cancer in women in Taiwan. There were 894 new cases in 2004 and 297 women died of ovarian cancer in 2001 according to the data released by the Department of Health. ...
Eligibility Criteria
Inclusion
- Histologically (Primary tumor with ≥ 50% clear cell histomorphology) or cytologically confirmed ovarian clear cell carcinoma The disease should be documented recurrence or resistant to primary platinum and paclitaxel based adjuvant chemotherapy.
- Patients are relapsed, not amenable to curative surgery or radiotherapy.
- not considered to required palliative chemotherapy nor radiotherapy
- Abnormal elevated serum CA125 tumor marker for no measurable disease by physical examination or image study, roentgenogram or computed tomography (CT) scan. Serum level of CA125 is higher than 80 IU/ml, or serum level of CA125 is at least 2 fold on day 14 than original serum level of CA125 which is higher than 35 IU/ml but less than 80 IU/ml on day 0.
- Evidence of measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
- Female, 20 years of age or older.
- GOG performance status of 0 - 2.
- GOG performance status 0-2
- Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgery to NCI CTCAE grade ≤1(except for alopecia).
- Life expectancy of at least 8 weeks
- Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN) or AST and ALT ≤5 x ULN if liver function abnormalities are due to underlying malignancy (liver metastases)
- Total serum bilirubin ≤1.5 x ULN
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets ≥100,000/µL
- Hemoglobin ≥9.0 g/dL
- Serum creatinine ≤1.5 x ULN
- QTc interval ≤450 msec for males and ≤470 msec for females (based on a mean value from 3 ECGs)
- Left ventricular ejection fraction (LVEF) ≥lower limit of institutional normal (LLN) as assessed by multigated acquisition (MUGA) scan or echocardiogram
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion
- Any of the following: known, severe hypersensitivity to sunitinib or any of the excipient of this product, unable to swallow sunitinib, previous treatment with sunitinib
- Major surgery or radiation therapy within 4 weeks of study treatment.
- Evidence of tumor bleeding within 4 weeks of study treatment.
- NCI CTCAE grade ≥3 hemorrhage within 4 weeks of study treatment.
- Newly diagnosed CNS metastases that have not been adequately controlled
- Ongoing cardiac dysrhythmias of grade ≥2.
- Hypertension that cannot be controlled by medication (\>150/100 mmHg despite optimal medical therapy).
- Any of the following within the 12 months prior to study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolism.
- Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months.
- Ongoing treatment with therapeutic doses (with therapeutic INR levels) of coumarin derivatives (low dose up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed) or oral anti-vitamin K agents.
- PT \>1.5 x ULN
- Known human immunodeficiency virus (HIV) infection.
- Current treatment on another clinical trial.
- Pregnancy or breastfeeding. Patients who are unwilling or unable to use adequate contraception to prevent pregnancy during the study. All female patients with reproductive potential must have a negative pregnancy test prior to study entry.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01824615
Start Date
January 1 2013
End Date
January 1 2016
Last Update
July 18 2018
Active Locations (1)
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1
Cathay General Hospital
Taipei, Taiwan, 106