Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Determination of genetic changes in patients with non-small cell lung cancer may help predict the outcome of treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study genetic changes and the effectiveness of combining vinorelbine with gemcitabine before surgery in treating patients who have stage IB, stage II, or stage III non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: Gemcitabine; Vinblastine; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell carcinoma of the lung

• May be confirmed at the initial bronchoscopy and mediastinoscopy

• Stage IB (T2, N0, M0)

• Stage IIA (T1, N1, M0)

• Stage IIB (T2-3, N0-1, M0)

• Stage IIIA (T1-3, N1-2, M0)

• stage IIIB (2 lesions in 1 lobe [T4])

• No N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scaline) OR T4 primary tumor (malignant pleural effusion or mediastinal invasion) by clinical staging criteria (seen on CT or PET scan and proven by mediastinoscopy)

• No metastatic disease (except N1 or N2 disease) or malignant pleural effusion* detected on preoperative evaluation

• No exudative effusions (even if cytologically negative)

• Pleural fluid is considered exudative if the following apply:

• Ratio of pleural fluid protein to serum protein is greater than 0.5

• Ratio of pleural fluid lactic dehydrogenase (LDH) to serum LDH is at least 0.6

• Pleural fluid LDH is greater than 200 IU/L

• No multiple areas of fluorodeoxyglucose (FDG) uptake** outside the area of the primary tumor in the lung NOTE: *Effusions visible only on CT scan and not large enough for safe thoracentesis are allowed

NOTE: **If only 1 area shows an increase in FDG uptake, the area of concern requires further evaluation (e.g., biopsy) to exclude metastatic disease

• Bidimensionally measurable or evaluable disease* NOTE: *Lesions apparent on chest CT scan (e.g., ill-defined masses associated with post obstructive changes and mediastinal or hilar adenopathy measurable in 1 dimension) are considered evaluable

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9 g/dL

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• AST or ALT no greater than 1.5 times upper limit of normal

Renal

• Creatinine no greater than 1.5 mg/dL

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Deemed medically fit for surgical resection

• No other active malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No psychological, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Concurrent participation in the RPCI vaccine study (postoperative vaccination with autologous tumor-associated antigen-pulsed dendritic cells) is allowed

Chemotherapy

• No prior chemotherapy for lung cancer

• No concurrent participation in another study involving other chemotherapy agents

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for lung cancer

• No concurrent participation in another study involving radiotherapy

Surgery

• No prior surgery for lung cancer

• More than 3 months since other prior major surgery (e.g., coronary artery bypass graft)

Other

• No other prior therapy for lung cancer

• No other concurrent antineoplastic agents

• Concurrent participation in observational studies requiring bloodwork, radiographs, pulmonary function tests, or quality of life studies is allowed