Efficacy and Safety of Pazopanib Monotherapy After First-line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Asian Women
Condition: Neoplasms, Ovarian
MeSH terms: Ovarian Neoplasms
Intervention: Pazopanib; Placebo comparator
Intervention description: Pazopanib 800 mg daily for 24 months; Placebo 800 mg daily for 24 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tyrosine kinase inhibitors; Primary Peritoneal Carcinoma; primary peritoneal cancer; ovarian cancer; Fallopian Tube Cancer; gynecologic cancer; anti-angiogenesis; pazopanib

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  written informed consent

          -  At least 18 years old.

          -  Histologically confirmed, International Federation of Gynecology and Obstetrics (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

          -  Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to
             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

          -  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.

          -  Prior or concurrent invasive malignancies that currently or within the last 5 years
             show/ed activity of disease (except ovarian, fallopian tube, or peritoneal cancer, or
             concurrent endometrial cancer FIGO stages IA/B)