Lung Cancer Clinical Trial
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given with combination chemotherapy and to see how well they work in treating patients with non-small cell lung cancer that cannot be surgically removed.
Full Description
OBJECTIVES:
Determine the maximum tolerated dose of radiotherapy in combination with carboplatin and paclitaxel in patients with unresectable non-small cell lung cancer.
Determine the 2-year survival of patients treated with this regimen.
Determine the progression-free local control rate in patients treated this regimen.
Determine the tolerability of this regimen in these patients.
Assess the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of radiotherapy.
Patients undergo radiotherapy* once daily 5 days a week for 7 weeks and 2 days (a total of 37 fractions). Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once weekly for 7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
NOTE: *No prophylactic nodal radiotherapy is administered
Cohorts of 3-6 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are treated at that dose level in the phase II portion of the study.
Beginning 3 weeks after completion of radiotherapy, patients receive paclitaxel and carboplatin as above. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, once during the last week of radiotherapy, and then every 3 months for 2 years.
Patients are followed at 3 weeks, every 3 months for 21 months, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Stage I, II, or III NSCLC that is unresectable due to tumor extent or other medical reasons
Measurable disease
Tumor must not exceed volume that would require radiation volumes greater than those allowed on this study
No more than blunting of the costophrenic angle on chest x-ray due to pleural effusions
No more than small effusions seen on chest CT scan only
No supraclavicular adenopathy
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0-1
Life expectancy:
At least 12 weeks
Hematopoietic:
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
Direct bilirubin no greater than 1.5 times ULN
AST no greater than 3 times ULN
Renal:
Creatinine clearance at least 40 mL/min
Cardiovascular:
No New York Heart Association class III or IV heart disease
Pulmonary:
FEV_1 at least 1 L or 35% of predicted
Other:
No grade 2 or greater peripheral neuropathy
No weight loss of 10% or more within the past 3 months
No uncontrolled infection
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma (carcinoma in situ), or localized prostate cancer
No other severe underlying disease that would preclude study participation
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic:
No prior biologic therapy for NSCLC
No concurrent biologic therapy
No concurrent prophylactic filgrastim (G-CSF)
Chemotherapy:
No prior chemotherapy for NSCLC
No other concurrent chemotherapy
Endocrine therapy:
No prior endocrine therapy for NSCLC
Radiotherapy:
No prior radiotherapy for NSCLC
Surgery:
No prior surgery for NSCLC
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There are 39 Locations for this study
Scottsdale Arizona, 85259, United States
Jacksonville Florida, 32224, United States
Ames Iowa, 50010, United States
Des Moines Iowa, 50307, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
Adrian Michigan, 49221, United States
Lambertville Michigan, 48144, United States
Monroe Michigan, 48162, United States
Monroe Michigan, 48162, United States
Bemidji Minnesota, 56601, United States
Rochester Minnesota, 55905, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68124, United States
Omaha Nebraska, 68131, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58502, United States
Fargo North Dakota, 58122, United States
Fargo North Dakota, 58122, United States
Bowling Green Ohio, 43402, United States
Fremont Ohio, 43420, United States
Lima Ohio, 45804, United States
Maumee Ohio, 43537, United States
Maumee Ohio, 43537, United States
Oregon Ohio, 43616, United States
Oregon Ohio, 43616, United States
Sandusky Ohio, 44870, United States
Sandusky Ohio, 44870, United States
Sylvania Ohio, 43560, United States
Tiffin Ohio, 44883, United States
Toledo Ohio, 43606, United States
Toledo Ohio, 43608, United States
Toledo Ohio, 43614, United States
Toledo Ohio, 43617, United States
Toledo Ohio, 43623, United States
Wauseon Ohio, 43567, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Fredericksburg Virginia, 22401, United States
La Crosse Wisconsin, 54601, United States
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