Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer
NCT ID: NCT00701870
Last Updated: 2013-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2008-10-31
2008-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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ezatiostat hydrochloride (Telintra®)
Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery
ezatiostat hydrochloride (Telintra®)
4500 mg orally per day in two divided doses
No Intervention
Chemotherapy with docetaxel and carboplatin alone
No interventions assigned to this group
Interventions
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ezatiostat hydrochloride (Telintra®)
4500 mg orally per day in two divided doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage IIIb-Stage IV NSCLC
* ECOG performance status of 0-2
* Adequate liver and renal function
* Adequate bone marrow reserve
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Telik
INDUSTRY
Responsible Party
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Principal Investigators
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Gail Brown, MD
Role: STUDY_DIRECTOR
Telik
Locations
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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
Fort 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
The 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
Countries
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Other Identifiers
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TLK199.2102
Identifier Type: -
Identifier Source: org_study_id