Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms
Intervention: Pazopanib; Placebo
Intervention description: Pazopanib 800 mg tablet daily for 104 weeks (24 months); Matching placebo 800 mg tablet daily, for 104 weeks (24 months).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Double (Participant, Investigator)
Enrollment: 940.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: fallopian tube cancer; pazopanib; anti-angiogenesis; ovarian cancer; primary peritoneal cancer; tyrosine kinase inhibitors; gynecologic cancer

Summary:

      This was a study to determine whether therapy with pazopanib was effective and safe in women
      with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not
      progressed on first line chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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
             have resolved.

          -  No evidence of disease progression

          -  ECOG status of 0 or 2

          -  Able to swallow and retain oral medication.

          -  Adequate hematologic, hepatic, and renal system function as follows:

        Hematologic

          -  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.

        Exclusion Criteria:

          -  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 to
             randomization

          -  Cardiac angioplasty or stenting

          -  Myocardial infarction

          -  Unstable angina

          -  Symptomatic peripheral vascular disease

               -  Class III or IV congestive heart failure

          -  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
             randomization

          -  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

          -  Invasive malignancies that showed activity of disease within 5 years prior to
             randomization