Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Condition: Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer
MeSH terms: Carcinoma, Ovarian Epithelial; Recurrence
Intervention: bevacizumab; laboratory biomarker analysis
Intervention description: Given IV; Correlative studies
Intervention MeSH terms: Bevacizumab; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is to see if bevacizumab works in treating patients who have persistent
      or recurrent ovarian epithelial cancer or primary peritoneal cancer. Monoclonal antibodies,
      such as bevacizumab, can block cancer growth in different ways. Some block the ability of
      cancer cells to grow and spread. Others find cancer cells and help kill them or deliver
      cancer-killing substances to them.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed ovarian epithelial or primary peritoneal carcinoma

               -  Recurrent or persistent after initial standard surgery or chemotherapy

               -  Incurable with standard surgery, chemotherapy, or radiotherapy

          -  At least 1 unidimensionally measurable target lesion

               -  At least 20 mm by conventional techniques

               -  At least 10 mm by spiral CT scan

               -  Outside the area of prior radiotherapy

          -  Accessible to guided core needle biopsy

          -  Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or
             another organoplatinum compound) for primary disease

               -  May have included high-dose therapy, consolidation, or extended therapy
                  administered after surgical or non-surgical assessment

               -  Patients with only 1 prior platinum-based chemotherapy regimen must have an
                  initial treatment-free interval of less than 12 months

               -  Patients with an initial treatment-free interval of more than 12 months must have
                  progressive disease after prior platinum-based chemotherapy regimen as
                  second-line therapy

          -  No tumors involving major blood vessels

          -  No evidence of CNS disease (primary brain tumor or brain metastases) within the past 5
             years

          -  Ineligible for higher priority Gynecologic Oncology Group (GOG) protocols (i.e.,
             active phase III GOG protocols for the same patient population)

          -  Performance status - GOG 0-2 (patients who have received 1 prior regimen)

          -  Performance status - GOG 0-1 (patients who have received 2 prior regimens)

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  No known bleeding disorder or coagulopathy

          -  No active bleeding

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  serum glutamate oxaloacetate transaminase (SGOT) ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  PT (INR) ≤ 1.5 (INR 2-3 if on stable dose of therapeutic warfarin or low molecular
             weight heparin)

          -  Partial thromboplastin time (PTT) < 1.2 times control

          -  Creatinine ≤ 1.5 times ULN

          -  Creatinine clearance > 60 mL/min

          -  No proteinuria, as indicated by 1 of the following:

               -  Negative urine dipstick

               -  Urine protein < 30 mg/dL

               -  Urine protein < 1,000 mg on 24-hour urine collection

          -  No clinically significant cardiovascular disease, including any of the following:

               -  Uncontrolled hypertension

               -  Myocardial infarction within the past 6 months

               -  Unstable angina within the past 6 months

               -  New York Heart Association class II-IV congestive heart failure

               -  Serious cardiac arrhythmia requiring medication

               -  Peripheral vascular disease ≥ grade 2

          -  No stroke within the past 5 years

          -  No pathologic condition that carries a high risk of bleeding

          -  No significant traumatic injury within the past 28 days

          -  No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

          -  No uncontrolled seizures within the past 5 years

          -  No neuropathy (motor and sensory) ≥ grade 2

          -  No serious non-healing wound, ulcer, or bone fracture

          -  No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
             human or humanized antibodies

          -  No active infection requiring parenteral antibiotics

          -  No known claustrophobia that would preclude MRI tolerance

          -  No ferromagnetic implants or pacers

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 3 months
             after study treatment

          -  At least 3 weeks since prior immunologic therapy directed at malignancy

          -  No prior bevacizumab

          -  No other concurrent immunotherapy directed at malignancy

          -  One additional prior cytotoxic regimen for recurrent or persistent disease allowed

          -  No prior non-cytotoxic chemotherapy for recurrent or persistent disease

          -  No concurrent chemotherapy directed at malignancy

          -  At least 1 week since prior hormonal therapy directed at malignancy

          -  No concurrent hormonal therapy directed at malignancy

          -  Concurrent hormone replacement therapy allowed

          -  Recovered from prior radiotherapy

          -  No concurrent radiotherapy directed at malignancy

          -  At least 28 days since prior major surgery or open biopsy and recovered

          -  At least 7 days since prior core biopsy or placement of vascular access device

          -  No anticipated need for major surgical procedure during study participation

          -  At least 3 weeks since other prior therapy directed at malignancy

          -  No prior anticancer therapy that would preclude study entry