Overview

Tarceva Surgery for Resectable Stage IIIA(N2) and IIIB (T4 N2) Non-Small-Cell Lung Cancer

Status:
Terminated
Trial end date:
2008-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Erlotinib Hydrochloride
Paclitaxel
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