A Phase II Evaluation of PS-341 (NSC# 681239) in the Treatment of Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer
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