Docetaxel in Non Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00258739

Purpose

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.

Condition	Intervention	Phase
Lung Neoplasms	Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine Other: Docetaxel + gemcitabine + carboplatin + radiotherapy	Phase II

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy

Drug Information available for: Carboplatin Gemcitabine Docetaxel Gemcitabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Response rate in each arm measured according to RECIST criteria [ Time Frame: Throughout the whole study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of local-regional control within a year [ Time Frame: Throughout the first year ] [ Designated as safety issue: No ]
Time to progression defined as the period of time elapsed between the randomization date and the progression or death date [ Time Frame: Throughout the whole study ] [ Designated as safety issue: No ]
Toxicity measured by CALGB criteria and RTOG/EORTC criteria [ Time Frame: Throughout the whole study ] [ Designated as safety issue: Yes ]
Global surveillance measured as the period of time elapsed between randomization and death date. [ Time Frame: Throughout the whole study duration ] [ Designated as safety issue: Yes ]

Enrollment:	140
Study Start Date:	October 2001
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258739

Locations

Spain
Sanofi-Aventis
Barcelona, Spain

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

José Mª Taboada

Sanofi-Aventis

More Information

Additional Information:

CSR synopsis This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	TAX_ES1_209
Study First Received:	November 23, 2005
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00258739
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carboplatin
Gemcitabine
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2009