Lung Cancer Clinical Trial
Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for treating non-small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have non-small cell lung cancer.
Full Description
OBJECTIVES:
Compare overall survival, response rate, and time to progression of patients with non-small cell lung cancer treated with paclitaxel and carboplatin versus gemcitabine and cisplatin.
Compare the toxicities of each of these 2 regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss in the past 6 months (less than 5% vs at least 5%) and disease stage (stage IIIB with pleural or pericardial effusion or pleural implants vs stage IV/recurrent). Patients are randomized to one of two treatment arms.
Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1.
Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 only.
Treatment continues in both arms every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 40-90 patients (20-45 per arm) will be accrued for this study within 12 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung carcinoma of any of the following subtypes:
Squamous cell
Adenocarcinoma
Large cell anaplastic
Bronchioalveolar
Non-small cell carcinoma not otherwise specified
No small cell anaplastic elements allowed
Must have:
Recurrent disease after prior radiotherapy or surgery OR
Stage IV disease with distant metastases OR
Stage IIIB disease presenting with pleural or pericardial effusion on CT or chest x-ray or pleural implants documented pathologically or on CT or chest x-ray
Bidimensionally measurable or evaluable disease
Brain metastases allowed provided clinically stable after treatment with surgery and/or radiotherapy
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 2
Life expectancy:
Not specified
Hematopoietic:
Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hepatic:
Bilirubin no greater than 1.5 mg/dL
SGOT no greater than 5 times upper limit of normal
Renal:
Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min
Cardiovascular:
No uncontrolled high blood pressure, unstable angina, or congestive heart failure
No myocardial infarction within the past 6 months
No serious ventricular arrhythmias requiring medication
Other:
Not pregnant or nursing
Fertile patients must use effective contraception
No other active malignancies requiring ongoing treatment
No uncontrolled serious active infections
No suspected hypersensitivity to agents that utilize Cremophor
No evidence of neuropathy grade 2 or greater by history or physical examination
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
No prior chemotherapy for non-small cell lung cancer
Endocrine therapy:
Not specified
Radiotherapy:
See Disease Characteristics
No prior radiotherapy to only site of measurable or evaluable disease unless subsequent progression documented by physical exam, radiograph, or pathology
Recovered from prior radiotherapy
No concurrent radiotherapy except for whole brain radiation for developing brain metastases
Surgery:
See Disease Characteristics
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There are 16 Locations for this study
Atlanta Georgia, 30322, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Papillion Nebraska, 68128, United States
Hackensack New Jersey, 07601, United States
New Brunswick New Jersey, 08903, United States
Albuquerque New Mexico, 87131, United States
Rochester New York, 14642, United States
Tulsa Oklahoma, 74136, United States
Hershey Pennsylvania, 17033, United States
Temple Texas, 76508, United States
Green Bay Wisconsin, 54307, United States
Westmead New South Wales, 2145, Australia
Lima , 34, Peru
San Juan , 00936, Puerto Rico
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