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

NCT ID: NCT00075517

Last Updated: 2008-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30

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.

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.

Conditions

Lung Cancer

Keywords

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

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: lead

Principal Investigators

Philippe Terrioux, MD

Role:

Clinique de Docteur Terrioux

Locations

Hopital Avicenne

Bobigny, , France

Centre Jean Bernard

Le Mans, , France

Hopital Perpetuel Secours

Levallois-Perret, , France

Centre de Radiotherapie et Oncologie Saint-Faron

Mareuil-lès-Meaux, , France

Clinique de Docteur Terrioux

Meaux, , France

American Hospital of Paris

Neuilly-sur-Seine, , France

Hopital Tenon

Paris, , France

Clinique les Bleuets

Reims, , France

Polyclinique De Courlancy

Reims, , France

Centre Rene Huguenin

Saint-Cloud, , France

Clinique Francois

Saint-Dizier, , France

Hopital Paul Brousse

Villejuif, , France

Countries

France

Other Identifiers

FRE-GERCOR-DOCEGEM-B00-2

Identifier Type: -

Identifier Source: secondary_id

EU-20331

Identifier Type: -

Identifier Source: secondary_id

CDR0000346806

Identifier Type: -

Identifier Source: org_study_id