Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258739
• Other study ID #: TAX_ES1_209
• Status: Completed
• Phase: Phase 2
• First received: November 23, 2005
• Last updated: December 4, 2009
• Start date: October 2001

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

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.

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).

Locations

Country	Name	City	State
Spain	Sanofi-Aventis	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate in each arm measured according to RECIST criteria		Throughout the whole study	No
Secondary	Percentage of local-regional control within a year		Throughout the first year	No
Secondary	Time to progression defined as the period of time elapsed between the randomization date and the progression or death date		Throughout the whole study	No
Secondary	Toxicity measured by CALGB criteria and RTOG/EORTC criteria		Throughout the whole study	Yes
Secondary	Global surveillance measured as the period of time elapsed between randomization and death date.		Throughout the whole study duration	Yes