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Phase II Trial of Pemetrexed in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with stage III or stage IV non-small cell lung cancer.
OBJECTIVES: Primary * Assess overall survival of patients with selected stage IIIB or IV bronchoalveolar carcinoma treated with pemetrexed disodium. Secondary * Evaluate the progression-free survival of patients treated with this drug. * Evaluate the response rate (confirmed and unconfirmed, partial and complete) in the subset of patients with measurable disease treated with this drug using standard RECIST criteria and computer assisted image analysis. * Evaluate frequency and severity of toxicities in patients treated with this drug. * Perform molecular correlative studies on patient tissue to investigate potential predictors of efficacy. (This will not be completed as this study was closed due to poor accrual.) OUTLINE: Patients are stratified according to prior treatment with gefitinib or erlotinib (yes vs no). Patients receive pemetrexed disodium intravenous (IV) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 3 years. PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States
NEA Medical Center - Stadium Boulevard
Jonesboro, Arkansas, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States
Start Date
July 1, 2006
Primary Completion Date
July 1, 2011
Completion Date
July 1, 2011
Last Updated
November 1, 2012
27
ACTUAL participants
pemetrexed
DRUG
Lead Sponsor
SWOG Cancer Research Network
Collaborators
NCT07336732
NCT07485114
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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