search
Back to results

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

Primary Purpose

Non-small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ezatiostat hydrochloride (Telintra®)
Sponsored by
Telik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-small Cell Lung Cancer focused on measuring NSCLC, Chemotherapy induced neutropenia, CIN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Hematology Oncology Medical Group
  • Pacific Cancer Medical Center, Inc.
  • Providence St. Joseph Medical Center
  • St. Jude Heritage Healthcare
  • Wilshire Oncology Medical Group
  • UCLA Medical Center
  • Clinical Trials and Research Associates, Inc.
  • North Valley Hematology/Oncology Medical Group
  • Ventura County Hematology-Oncology Specialists
  • Samsum Clinic
  • Santa Barbara Hematology Oncology Medical Group, Inc.
  • Central Coast Medical Oncology Corporation
  • Broward Oncology Associates
  • Nature Coast Clinical Research
  • Lakeland Regional Cancer Center
  • Florida Hospital Cancer Institute
  • Suburban Hematology-Oncology Associates, PC
  • Medical & Surgical Specialists
  • Joliet Oncology/Hematology Associates, Ltd.
  • Comprehensive Cancer Centers of Nevada
  • Montefiore Medical Center
  • Case Medical Center-University Hospitals
  • The University of Oklahoma Health Sciences Center
  • Coastal Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ezatiostat hydrochloride (Telintra®)

No Intervention

Arm Description

Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery

Chemotherapy with docetaxel and carboplatin alone

Outcomes

Primary Outcome Measures

Duration of chemotherapy induced neutropenia

Secondary Outcome Measures

Duration of chemotherapy induced severe neutropenia
Time to ANC recovery from ANC nadir
Incidence of febrile neutropenia
Incidence of G-CSF administration
FACT-N quality of life assessment
safety assessments

Full Information

First Posted
June 18, 2008
Last Updated
November 25, 2013
Sponsor
Telik
search

1. Study Identification

Unique Protocol Identification Number
NCT00701870
Brief Title
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

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Study TLK199.2102 was terminated for lack of enrollment.
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telik

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
NSCLC, Chemotherapy induced neutropenia, CIN

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ezatiostat hydrochloride (Telintra®)
Arm Type
Experimental
Arm Description
Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Chemotherapy with docetaxel and carboplatin alone
Intervention Type
Drug
Intervention Name(s)
ezatiostat hydrochloride (Telintra®)
Other Intervention Name(s)
Telintra tablets, ezatiostat tablets
Intervention Description
4500 mg orally per day in two divided doses
Primary Outcome Measure Information:
Title
Duration of chemotherapy induced neutropenia
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Duration of chemotherapy induced severe neutropenia
Time Frame
6 weeks
Title
Time to ANC recovery from ANC nadir
Time Frame
6 weeks
Title
Incidence of febrile neutropenia
Time Frame
6 weeks
Title
Incidence of G-CSF administration
Time Frame
6 weeks
Title
FACT-N quality of life assessment
Time Frame
6 weeks
Title
safety assessments
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Brown, MD
Organizational Affiliation
Telik
Official's Role
Study Director
Facility Information:
Facility Name
Central Hematology Oncology Medical Group
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
Pacific Cancer Medical Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Providence St. Joseph Medical Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
St. Jude Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Wilshire Oncology Medical Group
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Clinical Trials and Research Associates, Inc.
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
North Valley Hematology/Oncology Medical Group
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Ventura County Hematology-Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Samsum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Santa Barbara Hematology Oncology Medical Group, Inc.
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Central Coast Medical Oncology Corporation
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Broward Oncology Associates
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Ormand Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Suburban Hematology-Oncology Associates, PC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Medical & Surgical Specialists
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Joliet Oncology/Hematology Associates, Ltd.
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Case Medical Center-University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Coastal Cancer Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572-4128
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs