Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

May 30, 2012 updated by: Telik

Phase 1-2a Dose-Ranging Study of the Triplet Combination of Carboplatin, Paclitaxel and TLK286 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 1

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
      • Concord, California, United States, 94520
        • Bay Area Cancer Research Group
      • Concord, California, United States, 94520
        • East Bay Medical Oncology/Hematology Associates
      • Escondido, California, United States, 92025
        • Southwest Cancer Care
      • Hayward, California, United States, 94545
        • Kaiser Permanente Medical Center
      • Murrieta, California, United States, 92562
        • Southwest Cancer Care
      • Oakland, California, United States, 94611
        • Kaiser Permanente Medical Center
      • Poway, California, United States, 92064
        • Southwest Cancer Care
      • Sacramento, California, United States, 95825
        • Kaiser Permanente Medical Center
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Medical Center
      • San Jose, California, United States, 95119
        • Kaiser Permanente Medical Center
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center
      • So. San Francisco, California, United States, 94080
        • Kaiser Permanente Medical Center
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente Medical Center
      • Walnut Creek, California, United States, 94520
        • Diablo Valley Oncology & Hematology Medical Group
    • Florida
      • Crystal River, Florida, United States, 34429
        • Citrus Hematology and Oncology
      • Inverness, Florida, United States, 34452
        • Citrus Hematology and Oncology Center
      • Inverness, Florida, United States, 34452
        • Florida Wellcare Alliance, LC
    • Kansas
      • Kansas City, Kansas, United States, 66112
        • Kansas City Cancer Center
      • Lenexa, Kansas, United States, 66214
        • Kansas City Cancer Center - Central Research Dept. Data Office & Drug Discovery Location
      • Overland Park, Kansas, United States, 66210
        • Kansas City Cancer Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center
      • Shreveport, Louisiana, United States, 71101
        • Department of Veterns Affairs - Overton Brooks VA Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore University of Maryland Medical System-Greenebaum Cancer Center
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders, P. C.
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Cancer Center
      • Kansas City, Missouri, United States, 64111
        • Kansas City Cancer Center
      • Kansas City, Missouri, United States, 64154
        • Kansas City Cancer Center
      • Lee's Summit, Missouri, United States, 64064
        • Kansas City Cancer Center
      • St. Louis, Missouri, United States, 63141
        • St. John's Mercy Medical Center
      • Washington, Missouri, United States, 63090
        • St. John's Mercy Hospital
    • Nebraska
      • Scottsbluff, Nebraska, United States, 69361
        • Clinical Research Service
      • Scottsbluff, Nebraska, United States, 69361
        • Horizons West Medical Group
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Odyssey Research
      • Fargo, North Dakota, United States, 58103
        • Dakota Cancer Institute
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
        • Tennessee Oncology, PLLC
      • Franklin, Tennessee, United States, 37067
        • Tennessee Oncology, PLLC
      • Hermitage, Tennessee, United States, 37076
        • Tennessee Oncology, PLLC
      • Lebanon, Tennessee, United States, 37087
        • Tennessee Oncology, PLLC
      • Murfreesboro, Tennessee, United States, 37130
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37205
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37207
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37211
        • Tennessee Oncology, PLLC
      • Smyrna, Tennessee, United States, 37167
        • Tennessee Oncology, PLLC
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Cancer Associates
      • Plano, Texas, United States, 75093
        • Texas Cancer Associates
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Hematology & Oncology, Inc.

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:

  • 18 years of age or older
  • Histologically confirmed non-small cell lung cancer (NSCLC)
  • Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation)
  • Measurable disease by RECIST
  • ECOG status of 0-1
  • Adequate liver and renal function
  • Adequate bone marrow reserves

Exclusion Criteria:

  • Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC
  • Up to one prior adjuvant or neoadjuvant chemotherapy is allowed
  • History of bone marrow transplantation or stem cell support
  • Pregnant or lactating women

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Triplet Combination of TLK286 Carboplatin & Paclitaxel
Experimental
Drug: TLK286
Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²
Drug: carboplatin
AUC 6 mg/mL/min Once every 3 weeks
Drug: paclitaxel
200 mg/m² Once every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Objectives
Time Frame: Every 6 Weeks
  1. To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
  2. To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
  3. To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
Every 6 Weeks

Collaborators and Investigators

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

Sponsor

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

August 1, 2004

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

July 29, 2004

First Submitted That Met QC Criteria

July 29, 2004

First Posted (Estimate)

July 30, 2004

Study Record Updates

Last Update Posted (Estimate)

May 31, 2012

Last Update Submitted That Met QC Criteria

May 30, 2012

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLK286.2023

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.

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