Tarceva Surgery for Resectable Stage IIIA(N2) and IIIB (T4 N2) Non-Small-Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Tarceva (OSI-774); Paclitaxel; Carboplatin
Intervention description: 150 mg/day, starting day 1 and stopping night prior to surgery.; Planned dose of 200 mg/m^2 continuous IV infusion over 3 hours on Day 1 of each 21-day cycle.; Dose of AUC = 6 mg/ml × min began within 60 minutes following completion of paclitaxel infusion, infused over 15-30 minutes on Day 1 of Cycle 1 of each 21-day cycle, and then on Day 1 of each subsequent cycle according to institutional standards.
Intervention MeSH terms: Paclitaxel; Carboplatin; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; Lung Cancer; OSI-774; Tarceva; Carboplatin; Paclitaxel; NSCLC

Summary:

      The goal of this clinical research study is to learn about the safety and effectiveness of
      OSI-774 when combined with standard chemotherapy (carboplatin and paclitaxel) before surgery
      in the treatment of non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must have signed consent for LAB03-0383

          2. Pathologic documentation of NSCLC

          3. Stage IIIA and IIIB (T4 satellite nodules or invasion into T4 structures but no
             malignant effusion) with all patients requiring mediastinoscopy positive N2,
             potentially resectable disease. N3 disease is excluded.

          4. Measurable disease

          5. Zubrod performance status of 0 or 1

          6. Calculated post-resectional FEV1 of > 40%

          7. WBC>4000/l, ANC>1500/l, platelets > 100,000/l

          8. Serum creatinine < 1.5 ULN or calculated creatinine > 50 cc/min

          9. Total serum bilirubin <1.5 x ULN or SGPT or SGOT < 2 X ULN

         10. The following must be completed within 28 days of registration: CT scan of the chest
             and upper abdomen to include the adrenals. Mediastinoscopy to document ipsilateral
             nodal involvement and exclude N3 disease Blood tests, and pulmonary function tests The
             following must be completed within 2 months of registration: Pet scan If a CT PET is
             done more than 28 days, only the CT needs to be repeated and a bone scan to rule out
             bone metastases

        Exclusion Criteria:

          1. No prior chemotherapy or radiation for NSCLC

          2. No prior malignancy is allowed except for adequately treated basal cell or squamous
             cell skin cancer, in situ cervical cancer, or other cancer from which the patient has
             been disease-free for at least five years. If patient is suspected or known to have
             basal or squamous skin cancer, this maybe treated after induction chemotherapy is
             completed at the time of thoracotomy.

          3. No post-obstructive pneumonia or other serious infection or other serious underlying
             medical condition that would impair ability of patient to receive protocol treatment,
             including prior allergic reactions to drugs containing cremophor.

          4. Pregnant or nursing women may not participate