Lung Cancer
Conditions
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, irinotecan, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and irinotecan together with radiation therapy followed by docetaxel works in treating patients with newly diagnosed stage III non-small cell lung cancer.
Detailed description
OBJECTIVES: Primary * Determine the objective response rate in patients with newly diagnosed stage IIIA or IIIB non-small cell lung cancer treated with concurrent carboplatin, irinotecan hydrochloride, and radiotherapy followed by consolidation docetaxel. Secondary * Evaluate the safety, toxicity, and complications of this regimen in these patients. * Evaluate the median survival, 1-year and 2-year survival, and time to tumor progression in these patients. OUTLINE: * Chemoradiotherapy: Patients receive carboplatin IV over 30 minutes followed by irinotecan hydrochloride IV over 90 minutes on day 1. Patients also undergo radiotherapy once daily on days 1-5. Treatment repeats weekly for up to 7 courses in the absence of disease progression or unacceptable toxicity. * Consolidation chemotherapy: Beginning 3-4 weeks after completion of chemoradiotherapy, patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 4 years and then annually thereafter. PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Interventions
DRUGCarboplatin
CARBOPLATIN (AUC=2) IV in 250 cc NS over 30 minutes, weekly for seven weeks (Days #1, #8, #15, #22, #29, #36 and #43) along with radiation.
DRUGDocetaxel
DOCETAXEL 75 mg/m2 IV over one hour every three weeks for 3 cycles.
DRUGirinotecan hydrochloride
IRINOTECAN 30 mg/m2 IV over 90 minutes weekly for seven weeks (Days #1, #8, #15, #22, #29, #36 and #43) along with radiation.
RADIATIONradiation therapy
Radiotherapy will start on the first day of scheduled chemotherapy. The daily administered dose will be 1.8 Gy, 5 days a week for 4.4 weeks, 22 fractions, ( 39.6 Gy) to the primary tumor and mediastinum (primary planning target volume: PPTV). After 39.6 Gy, the same targets will be treated by oblique fields at 1.8 GY for 3 fxs to a toal dose of 45 GY. Thereafter, the primary tumor and involved nodal metastasis (secondary planning target volume SPTV) will be boosted at 2 Gy per day to 18 Gy in 9 fractions. The total dose will be 63 Gy in 35 fractions over seven weeks.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIA or IIIB disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques or \> 10 mm by spiral CT scan * No clinically significant malignant pleural or pericardial effusion (i.e., stage IIIB wet disease) PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Absolute neutrophil count \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Hemoglobin ≥ 8.0 g/dL * Bilirubin normal * Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria: * AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN) * AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST or ALT normal * Creatinine \< 2.0 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment * No New York Heart Association class III-IV heart disease * No history of serious cardiac disease not adequately controlled * No documented myocardial infarction within the past 6 months * No congestive heart failure * No unstable angina * No clinically significant arrhythmia * No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 * No peripheral neuropathy \> grade 1 * No other malignancy within the past 5 years other than skin cancer PRIOR CONCURRENT THERAPY: * More than 3 weeks since prior major surgery * No prior systemic chemotherapy, thoracic radiotherapy, or surgical resection for NSCLC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response (complete response, partial response, overall response) as measured by RECIST criteria prior to course 1 and within 1 month after completion of course 3 of consolidation chemotherapy | 5.25 years |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity/safety profile as measured by NCI CTCAE v 3.0 | 5.25 years |
| Median survival | 5.25 years |
| 1-year survival | 5.25 years |
| 2-year survival | 5.25 years |
| Time to disease progression | 5.25 years |
Countries
United States
Outcome results
None listed