Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00075517
Recruitment Status : Unknown
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2004
Last Update Posted : July 24, 2008
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: docetaxel Drug: gemcitabine hydrochloride Phase 2

Detailed Description:



  • Determine the response rate in patients with inoperable stage IIIB or IV non-small cell lung cancer treated with gemcitabine and docetaxel.


  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the tolerance profile of this regimen in these patients.
  • Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive docetaxel IV over 1 hour and gemcitabine IV over 2 hours on day 1. Treatment repeats every 15 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, after courses 6 and 12, and then every 3 months thereafter.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer
Study Start Date : September 2003

Primary Outcome Measures :
  1. Response rate

Secondary Outcome Measures :
  1. Progression-free survival
  2. Overall survival
  3. Tolerability
  4. Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed non-small cell lung cancer of 1 of the following histologic subtypes:

    • Epidermoid carcinoma
    • Large cell carcinoma
    • Adenocarcinoma
  • Stage IIIB (T4, any N, M0 OR any T, N3, M0) OR Stage IV disease
  • Inoperable disease
  • Measurable disease

    • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No symptomatic brain metastases



  • 18 to 75

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil count at least 2,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin no greater than normal
  • Transaminases no greater than 1.5 times normal
  • Alkaline phosphatase no greater than 2.5 times normal


  • Creatinine no greater than 2.3 mg/dL


  • No uncontrolled cardiac insufficiency


  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after study therapy
  • No uncontrolled infection
  • No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
  • No grade 3 or 4 brain disorder
  • No intolerance to polysorbate 80 or cortisones


Biologic therapy

  • Not specified


  • No prior chemotherapy, including taxanes or gemcitabine
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy to more than 20% of the bone marrow
  • No prior radiotherapy for lung cancer
  • At least 4 weeks since other prior radiotherapy and recovered


  • No prior surgery for lung cancer


  • More than 30 days since prior clinical trial participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00075517

Hopital Avicenne
Bobigny, France, 93009
Centre Jean Bernard
Le Mans, France, 72000
Hopital Perpetuel Secours
Levallois-Perret, France, 92300
Centre de Radiotherapie et Oncologie Saint-Faron
Mareuil Les Meaux, France, 77100
Clinique de Docteur Terrioux
Meaux, France, 77100
American Hospital of Paris
Neuilly Sur Seine, France, F-92202
Hopital Tenon
Paris, France, 75970
Clinique les Bleuets
Reims, France, 51100
Polyclinique De Courlancy
Reims, France, F-51100
Centre Rene Huguenin
Saint Cloud, France, 92211
Clinique Francois
Saint-Dizier, France, 52100
Hopital Paul Brousse
Villejuif, France, 94804
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
OverallOfficial: Philippe Terrioux, MD Clinique de Docteur Terrioux Identifier: NCT00075517     History of Changes
Other Study ID Numbers: CDR0000346806
First Posted: January 12, 2004    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: July 2007

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung
large cell lung cancer
squamous cell lung cancer

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