NCT00096187终止2 期
A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 25
- 主要终点
- Activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Granulocyte count ≥ 1,500/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •SGOT ≤ 3 times ULN
- •Alkaline phosphatase ≤ 3 times ULN
- •Creatinine ≤ 1.5 mg/dL
- •Creatinine clearance ≥ 45 mL/min
- •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
- •Recovered from prior surgery
- •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
排除标准
- 未提供
结局指标
主要结局
Activity
Toxicity
次要结局
未报告次要终点
研究者
研究点 (25)
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