Status:
COMPLETED
Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
- PATIENT CHARACTERISTICS:
- 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
- Bilirubin normal
- 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
- Uncontrolled angina
- Myocardial infarction
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00301808
Start Date
November 1 2005
End Date
October 1 2012
Last Update
May 6 2023
Active Locations (2)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
2
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201