Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Brief 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.
Detailed 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.
Interventions
DRUGcarboplatin
DRUGpaclitaxel
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) as assessed by dose-limiting toxicity within 1 month after completion of study treatment (phase I) | Up to 1 month |
| Survival at 2 years (phase II) | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Survival time | Up to 5 years |
| Toxicity | Up to 5 years |
| Time to progression | Up to 5 years |
| Time to local progression | Up to 5 years |
Countries
United States
Outcome results
None listed