Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

PRIMARY OBJECTIVES:

I. Determine the antitumor activity of bortezomib in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal carcinoma.

II. Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

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