Docetaxel in Non Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00258739
First received: November 23, 2005
Last updated: December 4, 2009
Last verified: December 2009
  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 2

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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
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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Spain
Sanofi-Aventis
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
Study Director: José Mª Taboada Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00258739     History of Changes
Other Study ID Numbers: TAX_ES1_209
Study First Received: November 23, 2005
Last Updated: December 4, 2009
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Docetaxel
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014