Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00701870
- Lead Sponsor
- Telik
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- Histologically confirmed NSCLC
- Stage IIIb-Stage IV NSCLC
- ECOG performance status of 0-2
- Adequate liver and renal function
- Adequate bone marrow reserve
- Treatment with neoadjuvant or adjuvant chemotherapy within 1 year
- Histologically confirmed mixed tumors containing small cell elements
- Treatment with radiotherapy (except limited in nature) within 3 weeks of randomization
- History of bone marrow transplantation or stem cell support
- Known history of CNS metastasis unless the patient has had treatment with surgery or radiotherapy, is neurologically stable and does not require oral or IV steroids or anticonvulsants
- History of HIV
- Grade 3 or 4 peripheral neuropathy
- Weightloss greater than 5% within 6 months
- Uncontrolled pleural effusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ezatiostat hydrochloride (Telintra®) ezatiostat hydrochloride (Telintra®) Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery
- Primary Outcome Measures
Name Time Method Duration of chemotherapy induced neutropenia 6 weeks
- Secondary Outcome Measures
Name Time Method Time to ANC recovery from ANC nadir 6 weeks Incidence of febrile neutropenia 6 weeks Incidence of G-CSF administration 6 weeks safety assessments 6 weeks Duration of chemotherapy induced severe neutropenia 6 weeks FACT-N quality of life assessment 6 weeks
Trial Locations
- Locations (24)
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
Case Medical Center-University Hospitals
🇺🇸Cleveland, Ohio, United States
Lakeland Regional Cancer Center
🇺🇸Lakeland, Florida, United States
Suburban Hematology-Oncology Associates, PC
🇺🇸Lawrenceville, Georgia, United States
St. Jude Heritage Healthcare
🇺🇸Fullerton, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Clinical Trials and Research Associates, Inc.
🇺🇸Montebello, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
🇺🇸Santa Barbara, California, United States
Wilshire Oncology Medical Group
🇺🇸La Verne, 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
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Broward Oncology Associates
🇺🇸Ft. Lauderdale, Florida, United States
Central Coast Medical Oncology Corporation
🇺🇸Santa Maria, California, United States
Medical & Surgical Specialists
🇺🇸Galesburg, Illinois, United States
Florida Hospital Cancer Institute
🇺🇸Ormand Beach, Florida, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Henderson, Nevada, United States
Joliet Oncology/Hematology Associates, Ltd.
🇺🇸Joliet, Illinois, United States
Coastal Cancer Center
🇺🇸Myrtle Beach, South Carolina, United States
The University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States