A Phase II Evaluation of Weekly Paclitaxel (NSC #673089) and Celecoxib (Celebrex®, NSC #719627) in the Treatment of Recurrent or Persistent Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Cancer
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial or primary peritoneal cancer
- Recurrent or persistent disease
- Measurable disease
- At least 1 unidimensionally measurable lesion at least 20 mm by conventional
techniques OR at least 10 mm by spiral CT scan
- At least 1 target lesion not in a previously irradiated field
- Must have received 1 prior platinum-based chemotherapy regimen for primary disease
containing carboplatin, cisplatin, or another organoplatinum compound
- Initial treatment may have included high-dose therapy, consolidation, or
extended therapy administered after surgical or non-surgical assessment
- Platinum-resistant or refractory (i.e., had a treatment-free interval after
platinum therapy of less than 6 months OR disease progression during
platinum-based therapy)
- Patients who have not received a prior taxane may have received a second regimen
that included paclitaxel or docetaxel
- Must not be eligible for a higher priority GOG protocol
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- SGOT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring antibiotics
- No neuropathy (sensory and motor) > grade 1
- No history of peptic ulcer disease
- No allergies to sulfa or non-steroidal anti-inflammatory drugs
- No known hypersensitivity to paclitaxel or celecoxib
- No other invasive malignancy within the past 5 years except non-melanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 weeks since prior biologic or immunologic therapy
- One prior non-cytotoxic* regimen for recurrent or persistent disease allowed NOTE:
*Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to)
monoclonal antibodies, cytokines, and small-molecule inhibitors of signal
transduction
Chemotherapy
- See Disease Characteristics
- Recovered from prior chemotherapy
- No other prior cytotoxic chemotherapy for recurrent or persistent disease, including
retreatment with initial chemotherapy regimen
Endocrine therapy
- At least 1 week since prior hormonal therapy for malignant tumor
- Concurrent hormone replacement therapy allowed
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
- No prior radiotherapy to more than 25% of marrow-bearing areas
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Other
- At least 3 weeks since prior therapy for malignant tumor
- No prior celecoxib
- No prior therapy for a previous cancer that would preclude protocol therapy
- No concurrent amifostine or other protective agents