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Status:

UNKNOWN

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

Lead Sponsor:

GERCOR - Multidisciplinary Oncology Cooperative Group

Conditions:

Lung Cancer

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

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 tumo...

Detailed Description

OBJECTIVES: Primary * Determine the response rate in patients with inoperable stage IIIB or IV non-small cell lung cancer treated with gemcitabine and docetaxel. Secondary * Determine the progress...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 to 75
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Platelet count at least 100,000/mm\^3
  • Absolute neutrophil count at least 2,000/mm\^3
  • Hemoglobin at least 10 g/dL
  • Hepatic
  • Bilirubin no greater than normal
  • Transaminases no greater than 1.5 times normal
  • Alkaline phosphatase no greater than 2.5 times normal
  • Renal
  • Creatinine no greater than 2.3 mg/dL
  • Cardiovascular
  • No uncontrolled cardiac insufficiency
  • Other
  • 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
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • No prior chemotherapy, including taxanes or gemcitabine
  • No other concurrent chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • 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
  • Surgery
  • No prior surgery for lung cancer
  • Other
  • More than 30 days since prior clinical trial participation

Exclusion

    Key Trial Info

    Start Date :

    September 1 2003

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00075517

    Start Date

    September 1 2003

    Last Update

    July 24 2008

    Active Locations (12)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (12 locations)

    1

    Hopital Avicenne

    Bobigny, France, 93009

    2

    Centre Jean Bernard

    Le Mans, France, 72000

    3

    Hopital Perpetuel Secours

    Levallois-Perret, France, 92300

    4

    Centre de Radiotherapie et Oncologie Saint-Faron

    Mareuil-lès-Meaux, France, 77100