RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one chemotherapy drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium together with radiation therapy followed by docetaxel works in treating patients with stage III non-small cell lung cancer.
OBJECTIVES: Primary * Assess 1-year survival of stage III non-small cell lung cancer (NSCLC) patients treated with cisplatin, pemetrexed disodium, and concurrent thoracic radiotherapy followed by consolidation therapy with docetaxel. Secondary * Assess the progression-free survival and overall survival. * Assess the toxicity of this regimen. OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over 60 minute on day 1. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients also receive concurrent thoracic radiotherapy in weeks 1-7. Between 3-8 weeks after completion of chemoradiotherapy, patients with no progressive disease receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for 3 courses. After completion of study therapy, patients are followed at 1 month and periodically thereafter. PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
Probability of Overall Survival at One Year
Overall Survival at one year using Kaplan-Meier product-limit analysis
Time frame: at 1 year
Progression-free Survival
Progression-free survival using Kaplan-Meier estimates
Time frame: Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.
Overall Survival
Overall survival using Kaplan-Meier estimates
Time frame: Date of registration to the date of death
Safety Outcomes
Toxicity: total number of SAEs and other AEs
Time frame: 72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year
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