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

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ClinicalTrials.gov Identifier: NCT00088556
Recruitment Status : Completed
First Posted : July 30, 2004
Last Update Posted : May 31, 2012
Sponsor:
Information provided by (Responsible Party):
Telik

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: TLK286 Drug: carboplatin Drug: paclitaxel Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2004
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088556


  Show 52 Study Locations
Sponsors and Collaborators
Telik
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT00088556     History of Changes
Other Study ID Numbers: TLK286.2023
First Posted: July 30, 2004    Key Record Dates
Last Update Posted: May 31, 2012
Last Verified: June 2011

Keywords provided by Telik:
Non-small cell lung cancer

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