Docetaxel in Non Small Cell Lung Cancer (NSCLC)

A Phase II, Randomized Study With Docetaxel-gemcitabine Followed by Radiotherapy vs Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) Followed by Docetaxel-gemcitabine Versus Docetaxel-gemcitabine Followed by Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) in Stage III NSCLC

Primary objective:

• To classify the 2 study groups, according to the tumoral response.

Secondary objectives:

• To evaluate the percentage of focused control per year.
• To calculate the time until progression.
• To evaluate the safety profile.

Study Overview

• Status: Completed
• Conditions: Lung Neoplasms
• Intervention / Treatment: Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine; Other: Docetaxel + gemcitabine + carboplatin + radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non small cell lung cancer confirmed by histology or by cytology.
• IIIB stage, except if existing pleural discharge, upper cava vein syndrome or supraclavicular affectation
• General stage 0-1 at the ECOG scale
• Loss of weight less than 5% in the 3 previous months from diagnose.
• Pulmonary function and gasometry results: FEV1 > 30% or 1 l, DLCO (diffusing capacity of the lung for carbon monoxide) > 30%, PCO2 < 45 mmHg and PO2 > 60 mmHg.
• Normal medullar function (hemoglobin > 11 g/dl, total WBC > 1,5 x 10^9/l, platelets > 100 x 10^9/l)
• Appropriate renal and hepatic functions
• CTScan
• Anticonceptive method
• Available laboratory test (maximum 1 month before)

Exclusion criteria:

• Pleural discharge, upper cava vein syndrome or supraclavicular affectation.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Concomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine	Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine; Docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy. Further on, 2 Docetaxel cycles and gemcitabine according to arm 2.
Experimental: 2; docetaxel-gemcitabine followed by concomitant radiotherapy with carboplatin-docetaxel	Other: Docetaxel + gemcitabine + carboplatin + radiotherapy; Docetaxel 40 mg/ m² days 1, 8, 21 and 28 with gemcitabine 1200 mg/ m² days 1, 8, 21 and 28 followed by concomitant treatment with docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy (2 Gy/day, 5 days per week and for 6 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate in each arm measured according to RECIST criteria	Throughout the whole study

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of local-regional control within a year	Throughout the first year
Time to progression defined as the period of time elapsed between the randomization date and the progression or death date	Throughout the whole study
Toxicity measured by CALGB criteria and RTOG/EORTC criteria	Throughout the whole study
Global surveillance measured as the period of time elapsed between randomization and death date.	Throughout the whole study duration

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: JOSÉ Mª TABOADA, Sanofi

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): September 1, 2007
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: November 23, 2005
• First Submitted That Met QC Criteria: November 23, 2005
• First Posted (Estimate): November 28, 2005

Study Record Updates

• Last Update Posted (Estimate): December 7, 2009
• Last Update Submitted That Met QC Criteria: December 4, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gemcitabine; Docetaxel; Carboplatin
• Other Study ID Numbers: TAX_ES1_209

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No