Carboplatin, Paclitaxel and TLK286 (Telcyta) 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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Bay Area Cancer Research Group, Concord, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TLK286

Drug

Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²

carboplatin

Drug

AUC 6 mg/mL/min Once every 3 weeks

paclitaxel

Drug

200 mg/m² Once every 3 weeks

Primary outcomes

Study Objectives

Time frame: Every 6 Weeks
- To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
- To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
- To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin

Sponsors and collaborators

Lead sponsor

Telik

Industry

Registry information

Official study 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

Important dates

Study start: 2004
Primary completion: 2009
Study completion: 2009
First posted: Jul 30, 2004
Registry last updated: May 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed