NCT00449657

Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

Phase II Trial of Pulsed Paclitaxel With Concurrent Radiotherapy,and Adjuvant Chemotherapy in Stage III Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Leo W. Jenkins Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer

Detailed description

OBJECTIVES Primary 1. Overall survival 2. Tumor response using RECIST criteria Secondary 1. Determine the toxicity of the proposed treatment in this patient population. 2. Progression free survival 3. Locoregional control 4. Distant failure STUDY DESIGN Description of the Study Phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer. Rationale for Study Design The proposed doses of gemcitabine, carboplatin, paclitaxel, and thoracic radiation therapy have been previously studied and deemed safe. The design of this study is not to find the maximum tolerated dose (MTD) of these agents, but to study the toxicity and overall survival from this combination. Outcome Measures Primary Outcome Measures 1. Overall survival 2. Tumor response using RECIST criteria Secondary Outcome Measures 1. Locoregional control 2. Distant Failure 3. Progression free survival

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Taxol (paclitaxel)	paclitaxel 15mg/m2 Q am on Mon/Wed/Fri
PROCEDURE	Radiotherapy	Off cord thoracic radiotherapy 200cGy (total dose 1000cGy). Mon/Wed/Fri: radiotherapy is delivered at least 6 hrs after chemotherapy. Tue/Thurs: radiotherapy is delivered 24 hrs or less from the paclitaxel dose the day before. Off-cord and off-esophagus concomitant boost radiotherapy 100 cGy (total dose 500 cGy)Mon/Wed/Fri of week 5
DRUG	Carboplatin	Carboplatin AUC 5mg/min/ml, prior to Gemcitabine on Wed of weeks 8 \& 9
DRUG	Gemcitabine	Gemcitabine 1000 mg/m2 at a fixed dose rate of 10mg/m2/min on Wed during week 8 \& 9

Timeline

• Start date: 2007-02-01
• Primary completion: 2017-08-22
• Completion: 2017-08-22
• First posted: 2007-03-20
• Last updated: 2018-03-14

Locations

1 site across 1 country: United States