Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy

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 low-risk gestational trophoblastic tumor after a molar pregnancy.

Detailed Description
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OBJECTIVES: Determine the activity of pemetrexed disodium as salvage therapy in patients with persistent or recurrent low-risk post-molar gestational trophoblastic tumor that failed prior dactinomycin or methotrexate. Determine the 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 unacceptable toxicity or disease progression or until tumor marker levels (human chorionic gonadotropin [hCG]) become normal. Patients receive 2 additional courses beyond the attainment of a normal hCG. 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 2 weeks for 2 months and then monthly for 10 months. PROJECTED ACCRUAL: Approximately 17-55 patients will be accrued for this study within 20-50 months.

Official Title
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A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor

Conditions
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Gestational Trophoblastic Tumor

Intervention / Treatment
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* Drug: pemetrexed disodium


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of low-risk post-molar gestational trophoblastic tumor, defined as 1 of the following: Increasing human chorionic gonadotropin (hCG) levels on ≥ 3 consecutive measurements taken over ≥ a 2-week period Less than 10% decrease of hCG levels on 4 measurements taken over ≥ a 3-week period Persistent or recurrent disease Histologically confirmed complete or partial mole on initial evacuation Prior pregnancy ≤ 12 months ago No histologically confirmed choriocarcinoma or placental site trophoblastic tumor on initial evacuation Failed only 1 prior dactinomycin or methotrexate therapy (with or without leucovorin calcium) WHO score 2-6 No evidence of metastatic disease, except to the lung or vagina, on physical exam, chemistry, chest X-ray, and ultrasound No liver, spleen, brain, kidney, or gastrointestinal tract metastases No more than 8 metastatic lesions PATIENT CHARACTERISTICS: Age Any age Performance status GOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Granulocyte count ≥ 1,500/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) SGOT ≤ 3 times ULN Alkaline phosphatase ≤ 3 times ULN Renal Creatinine ≤ 1.5 mg/dL Creatinine clearance ≥ 45 mL/min Other Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study participation No significant infection No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent prophylactic filgrastim (G-CSF) unless for recurrent neutropenic complications No concurrent prophylactic thrombopoietic agents unless for recurrent grade 4 thrombocytopenia Chemotherapy See Disease Characteristics At least 7 days since prior dactinomycin or methotrexate (with or without leucovorin calcium) and recovered No prior pemetrexed disodium No other prior chemotherapy Endocrine therapy Not specified Radiotherapy At least 14 days since prior radiotherapy and recovered No prior radiotherapy to ≥ 25% of the bone marrow Surgery Recovered from prior surgery Other No nonsteroidal anti-inflammatory drugs or salicylates for 2 days (or 5 days for drugs with a long half-life) before, during, and for 2 days after pemetrexed disodium administration Concurrent low-dose aspirin (≤ 325 mg/day) allowed

Ages Eligible for Study
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Maximum Age: 120 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: pemetrexed disodium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low risk metastatic gestational trophoblastic tumor, recurrent gestational trophoblastic tumor, nonmetastatic gestational trophoblastic tumor