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Sponsored by: |
Tularik |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033722 |
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 | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: folic acid Drug: lometrexol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC)
Stage IIIB or IV
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 | |
Tyler Cancer Center | |
Tyler, Texas, United States, 75702 | |
U.S. Oncology Research Inc. | |
Houston, Texas, United States, 77060 | |
United States, Washington | |
Cancer Care Northwest | |
Spokane, Washington, United States, 99202 |
Study Chair: | David Tesarowski | Tularik |
Study ID Numbers: | CDR0000069316, TULA-T064031, USO-01103 |
Study First Received: | April 9, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00033722 |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer squamous cell lung cancer large cell lung cancer stage IIIB non-small cell lung cancer |
stage IV non-small cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer |
Thoracic Neoplasms Lometrexol Non-small cell lung cancer Recurrence Carcinoma Folic Acid Adenocarcinoma of lung |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Vitamin B Complex Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematinics Growth Substances Physiological Effects of Drugs |
Hematologic Agents Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Neoplasms Neoplasms by Site Vitamins Therapeutic Uses Micronutrients |