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Investigator(s):
Giuseppe Giaccone, M.D., Ph.D. Principal Investigator Phone: 301-496-4916 Fax: 301-402-0172 giacconeg@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-451-5433 ottenl@mail.nih.gov	Corrine Keen, R.N., M.S., O.C.N. Research Nurse Phone: 301-496-3778 ckeen@mail.nih.gov	Arlene Berman, R.N., M.S., O.C.N. Research Nurse Phone: 301-435-5609 arleneb@mail.nih.gov

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Primary Eligibility:

• Histologically or cytologically confirmed non-small cell lung cancer
• Stage IIIA (N2) disease (all patients will require a baseline mediastinoscopy to ensure histological proof of N2 disease)
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan
• No squamous cell cancer or mixed tumors with small cell elements
• No tumor of any histology in close proximity to a major vessel or cavitation
• No metastatic disease
• > 10 days since prior and no concurrent therapeutic anticoagulation or chronic daily treatment with aspirin (325 mg/day)
• Recovered from prior therapy
• No prior chemotherapy, radiotherapy, surgery, or biological therapy for lung cancer
• ECOG performance status (PS) 0–1 (Karnofsky PS 70–100%)
• Serum creatinine ≤ 1.5 mg/dL
• Hemoglobin ≥ 10 g/dL
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• AST and ALT ≤ 2.5 x upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 x ULN (≤ 2 x ULN in patients with evidence of Gilbert disease)
• LVEF > 40%
• INR ≤ 1.5
• Urine protein/creatinine ratio < 1
• PaO₂ > 65 mm Hg, paCO₂ < 45 mm Hg on room air arterial blood gases
• Anticipated post-op FEV₁ and DLCO ≥ 40% predicted
• If anticipated post-op FEV₁ or DLCO < 40% predicted, must have VO₂ > 15 mL/kg on oxygen consumption study
• Not pregnant or nursing; fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• HIV negative
• No active hepatitis B or C
• No history of uncontrolled or labile hypertension; hypertension controlled by medication allowed
• No history of a malignancy within the past 5 years, except carcinoma in situ of the cervix or nonmelanomatous skin cancer
• No history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or tracheoesophageal fistula
• No history of severe hypersensitivity reaction to compounds of similar chemical or biological composition to cisplatin, gemcitabine hydrochloride, bevacizumab, etoposide, or other agents used in the study
• No history of hemoptysis (≥ ½ teaspoon [≥ 2.5 mL] of bright red blood) unrelated to any diagnostic procedure
• No medical condition that would preclude study participation

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Study Outline:

This is a multicenter study.

Neoadjuvant therapy:

• Patients receive cisplatin IV over 1 hour on Day 1, gemcitabine hydrochloride IV over 1 hour on Days 1 and 8, and bevacizumab* IV over 60–90 minutes on Day 1
• Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity

[Note: *Treatment with bevacizumab repeats for Courses 1 and 2 only.]

Surgery:

• Beginning 4–6 weeks after completion of the last course of cisplatin and gemcitabine hydrochloride, patients undergo bronchoscopy and thoracotomy with lobectomy or pneumonectomy and mediastinal lymph node dissection

Adjuvant therapy:

• Beginning 4–8 weeks after surgery, patients receive cisplatin IV over 1 hour on Day 1 and etoposide IV over 1 hour on Days 1–3
• Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
• Blood and tumor samples are collected periodically
• After completion of study treatment, patients are followed at 1 month, every 3 months for 2 years, every 6 months for 3 years, and then yearly for 3 years

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/9/09
Updated: 8/21/09