Status:
TERMINATED
Paclitaxel and Celecoxib in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of cancer by stopping blo...
Detailed Description
OBJECTIVES: * Determine the antitumor activity of paclitaxel and celecoxib in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer. * Determine the...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00084448
Start Date
April 1 2004
Last Update
July 9 2013
Active Locations (1)
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1
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002