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Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non‑Small Cell Lung Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Telik
ClinicalTrials.gov Identifier:
NCT00701870
First received: June 18, 2008
Last updated: August 24, 2010
Last verified: June 2008
History of Changes
  Purpose

This is a multicenter Phase 2 randomized parallel-group study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with Stage IIIB or IV NSCLC receiving first‑line therapy with carboplatin and docetaxel. Patients will be randomized (2:1 allocation) to receive chemotherapy followed by Telintra or chemotherapy alone.


Condition Intervention Phase
Non-small Cell Lung Cancer
 Drug: Ezatiostat Hydrochloride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Telik:

Primary Outcome Measures:
  • Duration of chemotherapy induced neutropenia [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of chemotherapy induced severe neutropenia [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Time to ANC recovery from ANC nadir [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Incidence of febrile neutropenia [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Incidence of G-CSF administration [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • FACT-N quality of life assessment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • safety assessments [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: May 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery
 Drug: Ezatiostat Hydrochloride
4500 mg orally per day in two divided doses
Other Names:
  • Telintra tablets
  • ezatiostat tablets
No Intervention: 2
Chemotherapy with docetaxel and carboplatin alone
 Drug: Ezatiostat Hydrochloride
4500 mg orally per day in two divided doses
Other Names:
  • Telintra tablets
  • ezatiostat tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed NSCLC
  • Stage IIIb-Stage IV NSCLC
  • ECOG performance status of 0-2
  • Adequate liver and renal function
  • Adequate bone marrow reserve

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701870

Locations
United States, California
Central Hematology Oncology Medical Group
Alhambra, California, United States, 91801
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
Providence St. Joseph Medical Center
Burbank, California, United States, 91505
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
Wilshire Oncology Medical Group
La Verne, California, United States, 91750
UCLA Medical Center
Los Angeles, California, United States, 90095
Clinical Trials and Research Associates, Inc.
Montebello, California, United States, 90640
North Valley Hematology/Oncology Medical Group
Northridge, California, United States, 91325
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States, 93030
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, United States, 93105
Samsum Clinic
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Florida
Broward Oncology Associates
Ft. Lauderdale, Florida, United States, 33308
Nature Coast Clinical Research
Inverness, Florida, United States, 34452
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
Florida Hospital Cancer Institute
Ormand Beach, Florida, United States, 32174
United States, Georgia
Suburban Hematology-Oncology Associates, PC
Lawrenceville, Georgia, United States, 30045
United States, Illinois
Medical & Surgical Specialists
Galesburg, Illinois, United States, 61401
Joliet Oncology/Hematology Associates, Ltd.
Joliet, Illinois, United States, 60435
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, Ohio
Case Medical Center-University Hospitals
Cleveland, Ohio, United States, 44106
United States, Oklahoma
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Coastal Cancer Center
Myrtle Beach, South Carolina, United States, 29572-4128
Sponsors and Collaborators
Telik
Investigators
Study Director: Gail Brown, MD Telik
  More Information

No publications provided

Responsible Party: Gail Brown, MD Chief Medical Officer, Telik, Inc.
ClinicalTrials.gov Identifier: NCT00701870     History of Changes
Other Study ID Numbers: TLK199.2102
Study First Received: June 18, 2008
Last Updated: August 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Telik:
NSCLC
Chemotherapy induced neutropenia
CIN

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neutropenia
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013