A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have Not Progressed After First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- written informed consent
- At least 18 years old.
- Histologically confirmed, FIGO stage II-IV epithelial ovarian, fallopian tube or
primary peritoneal carcinoma that was treated with surgical debulking and at least
five cycles of platinum-taxane doublet chemotherapy.
- Study randomization at least 3 weeks and not more than 12 weeks from the date of the
last chemotherapy dose, and all major toxicities from the previous chemotherapy must
- No evidence of disease progression
- ECOG status of 0 or 1.
- Able to swallow and retain oral medication.
- Adequate hematologic, hepatic, and renal system function as follows:
- Absolute neutrophil count (ANC) at least 1.5 X 10^9/L
- Hemoglobin at least 9 g/dL (or 5.59 mmol/L)
- Platelets at least 100 X 10^9/L
- Prothrombin time (PT) or international normalized ratio (INR) up to 1.2 X ULN
- Activated partial thromboplastin time (aPTT) up to 1.2 X ULN Hepatic
- Total bilirubin up to 1.5 X ULN
- AST and ALT up to 2.5 X ULN Renal
- Serum creatinine up to 1.5 mg/dL
Or, if greater than 1.5 mg/dL:
Calculated creatinine clearance at least 50 mL/min Urine Protein
- Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram
determined by 24- hour urine protein analysis.
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR
childbearing potential, and agrees to use adequate contraception.
- Either (a) bulky disease, or (b) any residual disease which in the opinion of the
investigator will need imminent second-line therapy
- Synchronous primary endometrial carcinoma, or a past history of primary endometrial
carcinoma, are excluded unless certain conditions are met.
- Clinically significant gastrointestinal abnormalities
- Prolongation of corrected QT interval (QTc) > 480 msecs
- History of any one or more cardiovascular conditions within the past 6 months prior
- Poorly controlled hypertension
- History of cerebrovascular accident (including transient ischemic attacks), pulmonary
embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to
- Major surgery (including interval debulking) or trauma within 28 days, or minor
surgical procedures within 7 days, prior to randomization, or has any non-healing
wound, fracture, or ulcer.
- Evidence of active bleeding or bleeding diathesis.
- Hemoptysis within 6 weeks prior to randomization.
- Endobronchial metastases.
- Serious and/or unstable pre-existing medical (e.g., uncontrolled infection),
psychiatric, or other condition that could interfere with subject's safety, provision
of informed consent, or compliance to study procedures.
- Investigational or anti-VEGF anticancer therapy prior to study randomization.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to pazopanib.