NCT00087100已完成2 期
A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 23
- 主要终点
- Antitumor 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 persistent or recurrent endometrial cancer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •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
- •Creatinine clearance ≥ 45 mL/min
- •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
- •Recovered from prior surgery
- 另有 4 项未显示
排除标准
- 未提供
结局指标
主要结局
Antitumor activity
Toxicity
次要结局
未报告次要终点
研究者
研究点 (23)
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