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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075517
First received: January 9, 2004
Last updated: July 23, 2008
Last verified: July 2007
  Purpose

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 Intervention Phase
Lung Cancer
Drug: docetaxel
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]

Study Start Date: September 2003
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00075517

Locations
France
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
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Investigator: Philippe Terrioux, MD Clinique de Docteur Terrioux
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00075517     History of Changes
Other Study ID Numbers: CDR0000346806, FRE-GERCOR-DOCEGEM-B00-2, EU-20331
Study First Received: January 9, 2004
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

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:
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
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 November 27, 2014