This trial is active, not recruiting.

Condition lung cancer
Treatments docetaxel, gemcitabine hydrochloride
Phase phase 2
Sponsor Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Start date September 2003
Trial identifier NCT00075517, CDR0000346806, EU-20331, FRE-GERCOR-DOCEGEM-B00-2


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Response rate
time frame:

Secondary Outcomes

Progression-free survival
time frame:
Overall survival
time frame:
time frame:
Quality of life
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).