Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

Detailed Description
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OBJECTIVES: Determine the antitumor activity of paclitaxel in patients with recurrent or persistent platinum- and paclitaxel-resistant ovarian epithelial or primary peritoneal cancer. Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: Patients receive paclitaxel IV over 1 hour once weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 6-12 months.

Official Title
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A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer

Conditions
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Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent ovarian epithelial or primary peritoneal cancer Measurable disease At least 1 lesion measured in at least 1 dimension At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan At least 1 target lesion Tumors within a previously irradiated field considered non-target lesions Paclitaxel resistant Treatment-free interval of less than 6 months duration after treatment with prior paclitaxel OR Progression during prior paclitaxel-based therapy Platinum resistant or refractory Treatment-free interval of less than 6 months duration after treatment with prior platinum OR Progression during prior platinum-based therapy Ineligible for higher priority GOG protocol (any active GOG phase III protocol for the same patient population) PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: 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 Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No active infection requiring antibiotics No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer No grade 2 or greater neuropathy (sensory and motor) PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic or immunologic agents for cancer Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy for cancer and recovered Received at least 1 but no more than 2 prior platinum-based chemotherapy regimens containing carboplatin, cisplatin, or other organoplatinum compound for primary or recurrent disease Initial treatment may include high-dose therapy, consolidation, or extended therapy Received at least 1 prior paclitaxel-based chemotherapy regimen No prior paclitaxel or docetaxel with a schedule of less than a 3-week interval between doses No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens Endocrine therapy: At least 1 week since prior hormonal therapy for cancer Concurrent hormone replacement therapy allowed Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy for cancer and recovered No prior radiotherapy to site(s) of measurable disease No prior radiotherapy to more than 25% of marrow-bearing areas Surgery: At least 3 weeks since prior surgery for cancer and recovered Other: At least 3 weeks since other prior therapy for cancer No prior anticancer treatment that would preclude study No concurrent amifostine or other protective reagents
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: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 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