Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
About this trial
This is an interventional treatment trial for Primary Peritoneal Cavity Cancer
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
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (bortezomib)
Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.