NCT00033722Unknown2 期
A Phase II Multicenter Study Of Lometrexol Sodium And Folic Acid In Subjects With Previously Treated Stage IIIB or IV Non-Small Cell Lung Cancer
Tularik14 个研究点 分布在 1 个国家开始时间: 2002年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 14
研究概览
简要总结
RATIONALE: Lometrexol may stop or slow the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Folic acid may be effective in preventing or lessening the side effects of lometrexol. Combining lometrexol with folic acid may be an effective treatment for non-small cell lung cancer.
PURPOSE: Phase II trial to study the effectiveness of combining lometrexol with folic acid in treating patients who have stage IIIB or stage IV non-small cell lung cancer that has been previously treated.
详细描述
OBJECTIVES:
- Determine the overall response rate in patients with previously treated stage IIIB or IV non-small cell lung cancer when treated with lometrexol and folic acid.
- Determine the complete response rate, duration of response, and time to progression in patients treated with this regimen.
- Determine the 1-year survival rate and overall survival in patients treated with this regimen.
- Determine the safety profile of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral folic acid once daily on days -7 to 6. Patients also receive lometrexol IV over 30-60 seconds on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed up to 2 months after removal from study and then every 3 months thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-small cell lung cancer (NSCLC)
- •Stage IIIB or IV
- •Squamous cell carcinoma
- •Adenocarcinoma
- •Large cell carcinoma
- •Adenosquamous carcinoma
- •Progressive disease after receiving 1 cisplatin- or carboplatin-containing regimen for stage IIIB or IV disease
- •Measurable disease
- •At least 1 lesion at least 1 cm x 1 cm by CT scan either not in a previously irradiated field or showing clear evidence of disease progression after radiation
- •No symptomatic or rapidly increasing, moderate or large amounts of pleural effusion or ascites
- •No prior or concurrent CNS metastases (brain or meningeal)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3*
- •Platelet count at least 100,000/mm^3*
- •Hemoglobin at least 9.0 g/dL*
- •*Without transfusions or growth factors in the previous 7 days
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN) (regardless of liver involvement secondary to tumor)
- •AST and ALT no greater than 2.5 times ULN (5 times ULN if liver has tumor involvement)
- •Calculated creatinine clearance at least 60 mL/min using Cockroft and Gault formula
- •Gastrointestinal:
- •No inflammatory bowel disease
- •No radiation enteritis
- •No malabsorption syndrome
- •No inability to absorb folic acid
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during study
- •No known untreated vitamin B12 deficiency
- •HIV negative
- •No drug abusers
- •No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No severe concurrent disease or major comorbidity that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 3 weeks since prior biologic therapy for NSCLC and recovered from acute side effects
- •Prior treatment with an experimental vaccine allowed
- •No concurrent routine or prophylactic filgrastim (G-CSF), sargramostim (GM- CSF), or epoetin alfa
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy for NSCLC (6 weeks for mitomycin or nitrosourea) and recovered from acute side effects
- •Prior adjuvant or neoadjuvant chemotherapy allowed
- •Endocrine therapy:
- •Not specified
- 另有 8 项未显示
排除标准
- 未提供
研究者
研究点 (14)
Loading locations...
相似试验
已完成
2 期
Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck CancerHead and Neck CancerNCT00503997Vanderbilt-Ingram Cancer Center42
终止
2 期
Pemetrexed Disodium, Gemcitabine, and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung CancerLung CancerNCT00438204Barbara Ann Karmanos Cancer Institute39
已完成
2 期
Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line ChemotherapyMalignant MesotheliomaNCT01085630Alliance for Clinical Trials in Oncology72
已完成
2 期
Pemetrexed, Cisplatin, and Vitamin B12 in Treating Patients With Mesothelioma of the Chest That Cannot Be Removed by SurgeryMalignant MesotheliomaNCT00541073Centre Oscar Lambret60
已完成
2 期
Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical CancerCervical CancerNCT00691301Gynecologic Oncology Group55