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Brief Title: Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer
Official Title: Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Chemotherapy Induced Neutropenia in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Receiving First-Line Chemotherapy
Study ID: NCT00701870
Brief Summary: TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.
Detailed Description: TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel. After randomization, patients in Treatment Arm 1, chemotherapy with carboplatin and docetaxel will be administered on Day 1 of each cycle, followed by Telintra at a starting dose of 3000 mg total daily dose (1500 mg orally, twice daily) on Day 2 until the absolute neutrophil count improves as confirmed by two consecutive measurement at least 24 hours apart. In Treatment Arm 2 (control arm), chemotherapy alone consisting of carboplatin and docetaxel will be administered on Day 1 of each cycle.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Central Hematology Oncology Medical Group, Alhambra, California, United States
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
Providence St. Joseph Medical Center, Burbank, California, United States
St. Jude Heritage Healthcare, Fullerton, California, United States
Wilshire Oncology Medical Group, La Verne, California, United States
UCLA Medical Center, Los Angeles, California, United States
Clinical Trials and Research Associates, Inc., Montebello, California, United States
North Valley Hematology/Oncology Medical Group, Northridge, California, United States
Ventura County Hematology-Oncology Specialists, Oxnard, California, United States
Samsum Clinic, Santa Barbara, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
Broward Oncology Associates, Ft. Lauderdale, Florida, United States
Nature Coast Clinical Research, Inverness, Florida, United States
Lakeland Regional Cancer Center, Lakeland, Florida, United States
Florida Hospital Cancer Institute, Ormand Beach, Florida, United States
Suburban Hematology-Oncology Associates, PC, Lawrenceville, Georgia, United States
Medical & Surgical Specialists, Galesburg, Illinois, United States
Joliet Oncology/Hematology Associates, Ltd., Joliet, Illinois, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Montefiore Medical Center, Bronx, New York, United States
Case Medical Center-University Hospitals, Cleveland, Ohio, United States
The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Coastal Cancer Center, Myrtle Beach, South Carolina, United States
Name: Gail Brown, MD
Affiliation: Telik
Role: STUDY_DIRECTOR