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

Phase 1

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: TLK286; Drug: carboplatin; Drug: paclitaxel

• Registration Number: NCT00088556
• Lead Sponsor: Telik

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-07-29
• Study First Submitted QC: 2004-07-29
• Study First Posted: 2004-07-30
• Study Start: 2004-08
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2011-06
• Last Update Submitted: 2012-05-30
• Last Update Posted: 2012-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triplet Combination of TLK286 Carboplatin & Paclitaxel	TLK286	Experimental
Triplet Combination of TLK286 Carboplatin & Paclitaxel	paclitaxel	Experimental
Triplet Combination of TLK286 Carboplatin & Paclitaxel	carboplatin	Experimental

Primary Outcome Measures

Name	Time	Method
Study Objectives	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

Trial Locations

Locations (27)

Bay Area Cancer Research Group; 🇺🇸 Concord, California, United States

East Bay Medical Oncology/Hematology Associates; 🇺🇸 Concord, California, United States

Southwest Cancer Care; 🇺🇸 Poway, California, United States

Kaiser Permanente Medical Center; 🇺🇸 Walnut Creek, California, United States

Diablo Valley Oncology & Hematology Medical Group; 🇺🇸 Walnut Creek, California, United States

Citrus Hematology and Oncology; 🇺🇸 Crystal River, Florida, United States

Citrus Hematology and Oncology Center; 🇺🇸 Inverness, Florida, United States

Florida Wellcare Alliance, LC; 🇺🇸 Inverness, Florida, United States

Kansas City Cancer Center; 🇺🇸 Lee's Summit, Missouri, United States

Kansas City Cancer Center - Central Research Dept. Data Office & Drug Discovery Location; 🇺🇸 Lenexa, Kansas, United States

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