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

First Received on January 9, 2004. Last Updated on July 23, 2008 History of Changes

Sponsor:	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075517

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 II

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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Gemcitabine Docetaxel Gemcitabine hydrochloride

U.S. FDA Resources

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

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
Polyclinique De Courlancy
Reims, France, F-51100
Clinique les Bleuets
Reims, France, 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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Docetaxel
Antimetabolites, Antineoplastic

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 09, 2012