Pemetrexed Disodium 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, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

Detailed Description
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OBJECTIVES: Determine the antitumor activity of pemetrexed disodium in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer that failed higher priority treatment protocols. Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks. 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 Pemetrexed (ALIMTA LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma

Conditions
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Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: pemetrexed disodium


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 target lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan Tumors within a previously irradiated field are considered non-target lesions Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel Platinum-resistant or refractory disease Treatment-free interval < 6 months after prior platinum-based therapy OR progressed during platinum-based therapy Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population) PATIENT CHARACTERISTICS: Age Any age Performance status GOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 3 times ULN* AST and ALT ≤ 3 times ULN* NOTE: * ≤ 5 times ULN if due to hepatic metastases Renal Creatinine clearance ≥ 45 mL/min Other No other malignancy within the past 5 years except nonmelanoma skin cancer No neuropathy (sensory or motor) > grade 1 No active infection requiring antibiotics Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy One prior noncytotoxic (biologic or cytostatic) regimen allowed for management of recurrent or refractory disease, including, but not limited to, the following: Monoclonal antibodies Cytokines Small-molecule inhibitors of signal transduction At least 3 weeks since prior biologic or immunologic therapy At least 24 hours since prior growth factors No concurrent routine colony-stimulating factors Chemotherapy See Disease Characteristics Recovered from prior chemotherapy No prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens No prior pemetrexed disodium Endocrine therapy At least 1 week since prior hormonal therapy for the malignant tumor Concurrent hormone replacement therapy allowed Radiotherapy See Disease Characteristics No prior radiotherapy to > 25% of bone marrow At least 2 weeks since prior radiotherapy and recovered Surgery Recovered from prior surgery Other No prior cancer treatment that would preclude study participation No non-steroidal anti-inflammatory drugs (NSAIDs) for 2-5 days before, during, and for 1-2 days after study drug administration Concurrent low-dose (≤ 325 mg/day) aspirin allowed At least 3 weeks since other prior therapy for the malignant tumor
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: pemetrexed disodium|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