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

November 25, 2013 updated by: Telik

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ezatiostat hydrochloride (Telintra®)
Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery
Drug: ezatiostat hydrochloride (Telintra®)
4500 mg orally per day in two divided doses
Other Names:
  • ezatiostat tablets
  • Telintra tablets
No Intervention: No Intervention
Chemotherapy with docetaxel and carboplatin alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of chemotherapy induced neutropenia
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of chemotherapy induced severe neutropenia
Time Frame: 6 weeks
6 weeks
Time to ANC recovery from ANC nadir
Time Frame: 6 weeks
6 weeks
Incidence of febrile neutropenia
Time Frame: 6 weeks
6 weeks
Incidence of G-CSF administration
Time Frame: 6 weeks
6 weeks
FACT-N quality of life assessment
Time Frame: 6 weeks
6 weeks
safety assessments
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telik

Investigators

  • Study Director: Gail Brown, MD, Telik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLK199.2102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe