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Molecular and Genetic Changes in Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Cisplatin and Alimta - Phase II Study

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Molecular and Genetic Changes in Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Cisplatin and Alimta - Phase II Study



- 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.


- 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.


- 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

- 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

- 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.

Inclusion Criteria


- 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)

- Effusions visible only by CT scan and not large enough for safe thoracentesis

- 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



- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified


- WBC ≥ 3,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL


- Bilirubin ≤ 1.5 mg/dL

- SGOT or SGPT ≤ 1.5 times upper limit of normal


- Creatinine clearance ≥ 45 mL/min


- 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


Biologic therapy

- Not specified


- No prior chemotherapy for lung cancer

Endocrine therapy

- Not specified


- No prior radiotherapy for lung cancer


- No prior surgery for lung cancer

- At least 12 weeks since prior major surgery to the chest and abdomen


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologically complete response

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Grace K. Dy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage I non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263