Ovarian Cancer Clinical Trial

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

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 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.

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Full 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 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00084448

Recruitment Status:

Terminated

Sponsor:

Gynecologic Oncology Group

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There is 1 Location for this study

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Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00084448

Recruitment Status:

Terminated

Sponsor:


Gynecologic Oncology Group

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