Paclitaxel and Celecoxib in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer

Study Overview
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Brief Summary
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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 blood flow to the tumor and may increase the effectiveness of paclitaxel by making tumor cells more sensitive to the drug. Giving celecoxib together with paclitaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel together with celecoxib works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer.

Detailed Description
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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 nature and degree of toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and oral celecoxib twice daily on days 2-6, 9-13, and 16-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months.

Official Title
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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

Conditions
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Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: celecoxib
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor activity |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, primary peritoneal cavity cancer