Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Condition: Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer
MeSH terms: Carcinoma, Ovarian Epithelial; Recurrence
Intervention: bortezomib; laboratory biomarker analysis; pharmacological study
Intervention description: Given IV; Correlative studies; Correlative studies
Intervention MeSH terms: Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: Female
Healthy volunteers: No

Summary:

      Phase II trial to study the effectiveness of bortezomib in treating patients who have
      persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Bortezomib
      may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed persistent or recurrent ovarian epithelial or primary
             peritoneal carcinoma

          -  Measurable disease

               -  At least 20 mm by conventional techniques (e.g., palpation, x-ray, plain CT scan,
                  or MRI) OR at least 10 mm by spiral CT scan

          -  Must have had prior therapy with no more than 1 platinum-based chemotherapy regimen
             for primary disease (e.g., carboplatin, cisplatin, or other organoplatinum compound)

               -  A second regimen containing paclitaxel allowed provided patient received no prior
                  paclitaxel therapy

          -  Platinum-sensitive disease

               -  Treatment-free interval without progressive disease for more than 6 months but
                  less than 12 months after therapy with platinum-based regimen

          -  At least 1 target lesion outside previously irradiated field

          -  Ineligible for higher priority GOG protocol

          -  Performance status - GOG 0-2 (if received 1 prior therapy regimen)

          -  Performance status - GOG 0-1 (if received 2 prior therapy regimens)

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  SGOT no greater than 2.5 times ULN

          -  Alkaline phosphatase no greater than 2.5 times ULN

          -  Creatinine no greater than 1.5 times ULN

          -  No evidence of acute ischemia or significant conduction abnormality (e.g., left
             anterior hemiblock in the presence of right bundle branch block or second or third
             degree atrioventricular block) on electrocardiogram

          -  No myocardial infarction within the past 6 months

          -  No cerebrovascular event or transient ischemic attack within the past 6 months

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active infection requiring antibiotics

          -  No other invasive malignancy within the past 5 years except non-melanoma skin cancer

          -  No sensory or motor neuropathy greater than grade 1

          -  No more than 1 prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or
             small-molecule inhibitors of signal transduction) for recurrent or persistent disease

          -  At least 4 weeks since prior biological or immunological agents and recovered

          -  No prior cytotoxic chemotherapy for recurrent or persistent disease, including
             retreatment with initial chemotherapy regimen

          -  At least 4 weeks since prior chemotherapy and recovered

          -  At least 1 week since prior anti-cancer hormonal therapy and recovered

          -  Concurrent hormone replacement therapy allowed

          -  At least 4 weeks since prior radiotherapy and recovered

          -  No prior radiotherapy to target lesions

          -  No prior radiotherapy to more than 25% of marrow-bearing areas

          -  At least 4 weeks since prior surgery and recovered

          -  No prior bortezomib

          -  No prior anti-cancer therapy that would preclude study treatment

          -  No concurrent amifostine or other protective agents