NCT00087087已完成2 期
A Phase II Evaluation Of Pemetrexed (ALIMTA LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal 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
- 35
- 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 recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
详细描述
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.
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 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:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •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
- •Creatinine clearance ≥ 45 mL/min
- •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
- 另有 6 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 (35)
Loading locations...
相似试验
已完成
2 期
Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the CervixCervical CancerNCT00087113Gynecologic Oncology Group
终止
2 期
Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar PregnancyGestational Trophoblastic TumorNCT00096187Gynecologic Oncology Group55
已完成
2 期
Pemetrexed Disodium and Bevacizumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung CancerLung CancerNCT00268489Alliance for Clinical Trials in Oncology48
已完成
1 期
Pemetrexed Disodium in Treating Young Patients With Recurrent Solid TumorsUnspecified Childhood Solid Tumor, Protocol SpecificNCT00070473Children's Oncology Group33
已完成
2 期
Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial CancerEndometrial CancerNCT00087100Gynecologic Oncology Group51