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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00701870
• Other study ID #: TLK199.2102
• Status: Terminated
• Phase: Phase 2
• First received: June 18, 2008
• Last updated: November 25, 2013
• Start date: October 2008
• Est. completion date: November 2008

Study information

• Verified date: November 2013
• Source: Telik
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neutropenia
• Non-small Cell Lung Cancer

Intervention

Drug:
• ezatiostat hydrochloride (Telintra®)
4500 mg orally per day in two divided doses

Locations

Country	Name	City	State
United States	Central Hematology Oncology Medical Group	Alhambra	California
United States	Pacific Cancer Medical Center, Inc.	Anaheim	California
United States	Montefiore Medical Center	Bronx	New York
United States	Providence St. Joseph Medical Center	Burbank	California
United States	Case Medical Center-University Hospitals	Cleveland	Ohio
United States	Broward Oncology Associates	Ft. Lauderdale	Florida
United States	St. Jude Heritage Healthcare	Fullerton	California
United States	Medical & Surgical Specialists	Galesburg	Illinois
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Joliet Oncology/Hematology Associates, Ltd.	Joliet	Illinois
United States	Wilshire Oncology Medical Group	La Verne	California
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	Suburban Hematology-Oncology Associates, PC	Lawrenceville	Georgia
United States	UCLA Medical Center	Los Angeles	California
United States	Clinical Trials and Research Associates, Inc.	Montebello	California
United States	Coastal Cancer Center	Myrtle Beach	South Carolina
United States	North Valley Hematology/Oncology Medical Group	Northridge	California
United States	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Florida Hospital Cancer Institute	Ormand Beach	Florida
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

Sponsors (1)

Lead Sponsor	Collaborator
Telik

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of chemotherapy induced neutropenia		6 weeks	No
Secondary	Duration of chemotherapy induced severe neutropenia		6 weeks	No
Secondary	Time to ANC recovery from ANC nadir		6 weeks	No
Secondary	Incidence of febrile neutropenia		6 weeks	No
Secondary	Incidence of G-CSF administration		6 weeks	No
Secondary	FACT-N quality of life assessment		6 weeks	No
Secondary	safety assessments		6 weeks	No