Clinical trial NCT00701870: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
Chemotherapy induced neutropenia
CIN
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Duration of chemotherapy induced neutropenia
timeFrame: 6 weeks
Secondary outcomes:
measure: Duration of chemotherapy induced severe neutropenia
timeFrame: 6 weeks
measure: Time to ANC recovery from ANC nadir
timeFrame: 6 weeks
measure: Incidence of febrile neutropenia
timeFrame: 6 weeks
measure: Incidence of G-CSF administration
timeFrame: 6 weeks
measure: FACT-N quality of life assessment
timeFrame: 6 weeks
measure: safety assessments
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Alhambra
country: United States
facility: Central Hematology Oncology Medical Group
state: California
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc.
state: California
city: Burbank
country: United States
facility: Providence St. Joseph Medical Center
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Healthcare
state: California
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Montebello
country: United States
facility: Clinical Trials and Research Associates, Inc.
state: California
city: Northridge
country: United States
facility: North Valley Hematology/Oncology Medical Group
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology-Oncology Specialists
state: California
city: Santa Barbara
country: United States
facility: Samsum Clinic
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Hematology Oncology Medical Group, Inc.
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Ft. Lauderdale
country: United States
facility: Broward Oncology Associates
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Ormand Beach
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Lawrenceville
country: United States
facility: Suburban Hematology-Oncology Associates, PC
state: Georgia
city: Galesburg
country: United States
facility: Medical & Surgical Specialists
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology/Hematology Associates, Ltd.
state: Illinois
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Cleveland
country: United States
facility: Case Medical Center-University Hospitals
state: Ohio
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Myrtle Beach
country: United States
facility: Coastal Cancer Center
state: South Carolina
Study officials:
affiliation: Telik
name: Gail Brown, MD
role: STUDY_DIRECTOR
References: