Bevacizumab and Low-Dose Cyclophosphamide in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Condition: Primary Peritoneal Carcinoma; Recurrent Ovarian Carcinoma; Stage IV Ovarian Cancer
MeSH terms: Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Recurrence
Intervention: Bevacizumab; Cyclophosphamide; Laboratory Biomarker Analysis
Intervention description: Given IV; Given PO; Correlative studies
Intervention MeSH terms: Cyclophosphamide; Bevacizumab; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Immunoglobulin G; Endothelial Growth Factors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: Female
Healthy volunteers: No

Summary:

      This phase II trial is to see if combining bevacizumab with low-dose cyclophosphamide works
      in treating patients with ovarian epithelial or primary peritoneal cancer that has come back
      or spread to other parts of the body. 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.
      Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor
      cells from dividing so they stop growing or die. Combining bevacizumab with cyclophosphamide
      may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed recurrent or metastatic ovarian epithelial or primary
             peritoneal cancer

          -  Unidimensionally measurable disease

               -  Previously irradiated indicator lesions must have progressed after radiotherapy

          -  Received a platinum-containing regimen for primary disease

          -  No more than 2 prior chemotherapy regimens for recurrent disease

               -  Must have received prior platinum-based chemotherapy for recurrent disease if it
                  has been > 12 months since treatment for primary disease (except if
                  hypersensitivity to platinum has developed)

               -  Rechallenge with the same platinum-based regimen is considered 1 prior regimen

          -  No history or clinical evidence of CNS disease, including primary brain tumor

          -  No brain metastases

          -  Performance status - SWOG 0-2

          -  At least 3 months

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  No bleeding diathesis

          -  No coagulopathy

          -  Bilirubin no greater than 1.5 times normal

          -  ALT or AST no greater than 3 times upper limit of normal

          -  INR less than 1.5 (for patients receiving warfarin)

          -  Creatinine no greater than 1.5 times normal

          -  No proteinuria (less than 1+)

          -  Proteinuria less than 500 mg/24-hour urine collection

          -  No prior deep vein thrombosis

          -  No prior stroke

          -  No clinically significant cardiovascular disease

          -  None of the following within the past year:

               -  Uncontrolled hypertension

               -  New York Heart Association class II-IV congestive heart failure

               -  Serious cardiac arrhythmia requiring medication

               -  Grade II or greater peripheral vascular disease

          -  None of the following within the past 6 months:

               -  Unstable angina

               -  Myocardial infarction

               -  Transient ischemic attack

               -  Cerebrovascular accident

               -  Other arterial thromboembolic event

          -  No clinically significant peripheral artery disease

          -  No active infection requiring parenteral antibiotics

          -  No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
             human antibodies

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No serious, non-healing wound, ulcer, or bone fracture

          -  No significant traumatic injury within the past 28 days

          -  No seizures not controlled with standard medical therapy

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer or
             carcinoma in situ of the cervix

               -  All prior invasive malignancies must be in complete remission

          -  No other concurrent medical, psychological, or social condition that would preclude
             study participation

          -  No prior antiangiogenesis agents

          -  See Disease Characteristics

          -  Recovered from prior chemotherapy

          -  See Disease Characteristics

          -  Recovered from prior radiotherapy

          -  More than 28 days since prior major surgical procedure or open biopsy and recovered

          -  At least 3 weeks since prior therapy directed at the malignancy

          -  No recent or concurrent full-dose anticoagulants or thrombolytic agents

               -  Anticoagulants to maintain patency of preexisting, permanent indwelling IV
                  catheters allowed

          -  No concurrent chronic daily aspirin (greater than 325 mg/day) or nonsteroidal
             anti-inflammatory drugs known to inhibit platelet function