Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 to 75	Other	FRE-GERCOR-DOCEGEM-B00-2 EU-20331, NCT00075517

Objectives

Primary

1. Determine the response rate in patients with inoperable stage IIIB or IV non-small cell lung cancer treated with gemcitabine and docetaxel.

Secondary

1. Determine the progression-free and overall survival of patients treated with this regimen.
2. Determine the tolerance profile of this regimen in these patients.
3. Determine the quality of life of patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age

• 18 to 75

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Platelet count at least 100,000/mm³
• Absolute neutrophil count at least 2,000/mm³
• 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

Expected Enrollment

A total of 42 patients will be accrued for this study within 18 months.

Outcomes

Response rate

Progression-free survival
Overall survival
Tolerability
Quality of life

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.

Trial Contact Information

Trial Lead Organizations

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

Philippe Terrioux, MD, Study coordinator		Ph: 33-1-6024-7081 Email: ph.terrioux@wanadoo.fr

Registry Information
Official Title		Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer
Trial Start Date		2003-09-01
Registered in ClinicalTrials.gov		NCT00075517
Date Submitted to PDQ		2003-11-20
Information Last Verified		2007-07-31

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