Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial 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 persistent or recurrent endometrial cancer.

Detailed Description
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OBJECTIVES: Determine the antitumor activity of pemetrexed disodium in patients with persistent or recurrent endometrial adenocarcinoma 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: Approximately 19-51 patients will be accrued for this study within 1-3.4 years.

Official Title
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A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma

Conditions
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Endometrial 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 endometrial adenocarcinoma Persistent or recurrent disease Refractory to curative or standard therapy Measurable disease At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques, including 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 unless progression is documented or biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy Must have received 1 prior chemotherapy regimen for endometrial cancer Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment 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 AST and ALT ≤ 3 times upper limit of normal (ULN)* Alkaline phosphatase ≤ 3 times ULN* Bilirubin ≤ 1.5 times ULN NOTE: * ≤ 5 times ULN if liver metastases are present Renal Creatinine clearance ≥ 45 mL/min Other Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study participation Neuropathy (sensory and motor) ≤ grade 1 No active infection requiring antibiotics No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 weeks since prior biologic or immunologic agents for the malignant tumor One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following: Monoclonal antibodies Cytokines Small-molecule inhibitors of signal transduction At least 24 hours since prior growth factors No concurrent routine colony-stimulating factors Chemotherapy See Disease Characteristics Recovered from prior chemotherapy No more than 1 prior cytotoxic chemotherapy regimen with either single or combination cytotoxic drug therapy No prior pemetrexed disodium Endocrine therapy At least 1 week since prior hormonal therapy directed at the malignant tumor Concurrent hormone replacement therapy allowed Radiotherapy See Disease Characteristics At least 2 weeks since prior radiotherapy and recovered No prior radiotherapy to ≥ 25% of bone marrow Surgery Recovered from prior surgery Other At least 3 weeks since other prior therapy directed at the malignant tumor No nonsteroidal anti-inflammatory drugs 2-5 days before, during, and for 1-2 days after study drug administration Concurrent daily low-dose (≤ 325 mg/day) aspirin therapy allowed No prior therapy that would contraindicate study participation
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 endometrial carcinoma, endometrial adenocarcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma