Status:
COMPLETED
Pemetrexed Disodium and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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...
Detailed 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 ci...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 8 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2017
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00248495
Start Date
June 8 2005
End Date
April 5 2017
Last Update
July 12 2017
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001