Lung Cancer Clinical Trial
Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer
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.
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.
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.
Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria:
Stage IIIA disease, meeting all of the following criteria:
Mediastinal lymph node involvement
Greater than one mediastinal lymph node enlarged on CT scan, confirmed by positron emission tomography (PET) scan
Paralyzed left vocal cord with separate lung primary distinct from the aorto-pulmonary lymph nodes on the CT scan
Stage IIIB disease, meeting all of the following criteria:
N3 lymph node involvement
Enlarged N3 lymph nodes on CT scan confirmed by PET scan
Lymph node involvement may not extend to cervical lymph nodes other than supraclavicular lymph nodes
Right-sided primary tumor with left vocal cord paralysis
Evidence of tumor extension into the mediastinum and/or mediastinal structures by mediastinoscopy, bronchoscopy, or CT scan
No evidence of malignant pleural effusion unless effusion is only evident on CT scan
No more than 1 parenchymal lesions on the same or opposite sides of the lung
No brain metastases by CT scan or MRI
SWOG performance status 0 or 1
Platelet count ≥ 100,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Creatinine clearance ≥ 45 mL/min
Transaminases (SGOT and/or SGPT) ≤ 1.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN
Total lung volume (i.e., right and left lung minus the gross tumor volume) receiving greater than 20 Gy of radiation ≤ 40%
FEV_1 ≥ 70% of predicted
DLCO ≥ 50 mL/min
No other concurrent malignancy
Prior malignancy allowed provided it is in clinical control and is not likely to impact clinical outcome in the opinion of the treating physician
No peripheral neuropathy ≥ grade 2
No serious medical illness, including, but not limited to, any of the following:
Uncontrolled congestive heart failure
Cerebrovascular event within the past 6 months
History of chronic active hepatitis
History of HIV infection
Active bacterial infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Must be willing and able to take folic acid, cyanocobalamin (vitamin B12), or dexamethasone
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiotherapy for NSCLC
No concurrent participation in another therapeutic investigational study
Concurrent ibuprofen (400 mg four times daily) allowed during pemetrexed disodium administration provided the patient has normal renal function
No concurrent aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs) 2 days before, during, and for 2 days after pemetrexed disodium administration
Patients on long-acting NSAIDs (e.g. naproxen sodium, diflunisal, nabumetone, or celecoxib) must be willing or able to discontinue usage 5 days prior to, during, and for 2 days after pemetrexed disodium administration
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There is 1 Location for this study
Detroit Michigan, 48201, United States
Detroit Michigan, 48201, United States
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