Lung Cancer Clinical Trial
Pemetrexed Disodium and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Summary
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin 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) and giving them before and after surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin before and after surgery works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
Full Description
OBJECTIVES:
Primary
Determine the pathologic complete response in patients with stage IB-IIIB non-small cell lung cancer treated with neoadjuvant chemotherapy comprising pemetrexed disodium and cisplatin followed by surgery and adjuvant pemetrexed disodium and cisplatin.
Secondary
Determine the adverse events of this regimen in these patients.
Determine the overall and disease-free survival of patients treated with this regimen.
Correlate response with the presence or absence of ERCC1 and DHFR, thymidylate synthase, DPD, and GARFT in patients treated with this regimen.
Correlate the fragile site on chromosome 12 within the SMRT gene with metastasis after definitive treatment with this regimen in these patients.
OUTLINE:
Neoadjuvant chemotherapy: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses. Patients are then evaluated for disease resectability. Patients with no evidence of disease progression proceed to thoracotomy within the next 28-48 days.
Thoracotomy: Patients found to have unresectable disease during thoracotomy receive further treatment off study. Patients with resectable disease undergo complete surgical resection of the tumor. Forty to eighty days later, patients proceed to adjuvant chemotherapy.
Adjuvant chemotherapy: Patients receive pemetrexed disodium and cisplatin as before for 2 courses.
Patients with progressive disease after completion of neoadjuvant chemotherapy are followed every 6 months. All other patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study over 6.5 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Microscopically confirmed non-small cell lung cancer
Stage IB (T2, N0, M0), IIA (T1, N1, M0), IIB (T2, N1, M0 or T3, N0, M0), or IIIA (T1-3, N1-2, M0) disease
Satellite lesions in one lobe (T4) (stage IIIB) allowed
Meets 1 of the following criteria:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 10 mm in the longest diameter
Evaluable disease, defined as lesions on chest CT scan that are not measurable (e.g., ill-defined masses or mediastinal or hilar adenopathy)
No metastatic disease except peribronchial/hilar lymph nodes (N1) or ipsilateral/subcarinal mediastinal lymph nodes (N2)
No N3 lymph nodes (e.g., contralateral mediastinal/hilar or supraclavicular/scalene) by CT scan or positron emission tomography (PET) scan AND mediastinoscopy
No T4 primary tumor (e.g., mediastinal invasion)
No malignant pleural effusion
Nonmalignant effusions (i.e., negative cytology, non-bloody, and transudate) allowed
Effusions visible only by CT scan and not large enough for safe thoracentesis allowed
No exudative effusion, defined by 1 of the following criteria:
Pleural fluid protein:serum protein ratio > 0.5
Pleural fluid lactic dehydrogenase (LDH):serum LDH ratio ≥ 0.6
Pleural fluid LDH > 200 IU/L
No more than 1 area of fludeoxyglucose (FDG) uptake outside the area of the primary lung tumor OR evidence of malignant pleural disease as evidenced by pleural nodules by PET scan
Single areas of FDG uptake will be further evaluated (e.g., by biopsy) for metastatic disease
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-1
Life expectancy
Not specified
Hematopoietic
WBC ≥ 3,000/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9 g/dL
Hepatic
Bilirubin ≤ 1.5 mg/dL
SGOT or SGPT ≤ 1.5 times upper limit of normal
Renal
Creatinine clearance ≥ 45 mL/min
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
No other active malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No psychological, familial, sociological, or geographical situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
No prior chemotherapy for lung cancer
Endocrine therapy
Not specified
Radiotherapy
No prior radiotherapy for lung cancer
Surgery
No prior surgery for lung cancer
At least 12 weeks since prior major surgery to the chest and abdomen
Other
No concurrent aspirin or other nonsteroidal anti-inflammatory drugs for ≥ 2 days before (5 days for drugs with a long half-life [e.g., naproxen, piraoxicam, difunisal, nabumetone, rofecoxib, or celecoxib] or 8 days for long acting agents), during, and for 2 days after completion of each pemetrexed disodium administration
No concurrent participation in another study involving chemotherapy or radiotherapy
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There is 1 Location for this study
Buffalo New York, 14263, United States
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