Lometrexol Plus Folic Acid in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00033722|
Recruitment Status : Unknown
Verified November 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 6, 2003
Last Update Posted : January 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Dietary Supplement: folic acid Drug: lometrexol||Phase 2|
- 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.
PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||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|
|Study Start Date :||February 2002|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033722
|United States, California|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94143-0128|
|United States, Florida|
|Cancer Centers of Florida (U.S. Oncology)|
|Orlando, Florida, United States, 32806|
|United States, Louisiana|
|Louisiana State University School of Medicine|
|New Orleans, Louisiana, United States, 70112-2822|
|United States, New York|
|US Oncology - Albany Regional Cancer Center|
|Albany, New York, United States, 12208|
|United States, Texas|
|U.S. Oncology Research Inc.|
|Houston, Texas, United States, 77060|
|Tyler Cancer Center|
|Tyler, Texas, United States, 75702|
|United States, Washington|
|Cancer Care Northwest|
|Spokane, Washington, United States, 99202|
|Study Chair:||David Tesarowski||Tularik|