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

Lung Cancer Clinical Trial

Official title:

Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00075517
• Other study ID #: CDR0000346806
• Secondary ID: FRE-GERCOR-DOCEG
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 9, 2004
• Last updated: July 23, 2008
• Start date: September 2003

Study information

• Verified date: July 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• docetaxel

• gemcitabine hydrochloride

Locations

Country	Name	City	State
France	Hopital Avicenne	Bobigny
France	Centre Jean Bernard	Le Mans
France	Hopital Perpetuel Secours	Levallois-Perret
France	Centre de Radiotherapie et Oncologie Saint-Faron	Mareuil Les 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

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Secondary	Progression-free survival			No
Secondary	Overall survival			No
Secondary	Tolerability			Yes
Secondary	Quality of life			No