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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Telik
ClinicalTrials.gov Identifier:
NCT00088556
First received: July 29, 2004
Last updated: May 30, 2012
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: TLK286
Drug: carboplatin
Drug: paclitaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Telik:

Primary Outcome Measures:
  • Study Objectives [ Time Frame: Every 6 Weeks ] [ Designated as safety issue: Yes ]
    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


Enrollment: 100
Study Start Date: August 2004
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088556

  Show 52 Study Locations
Sponsors and Collaborators
Telik
  More Information

No publications provided

Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT00088556     History of Changes
Other Study ID Numbers: TLK286.2023
Study First Received: July 29, 2004
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Telik:
Non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 30, 2014