Phase II Trial of Induction Gemcitabine and Carboplatin Followed by Paclitaxel and Carboplatin With Concurrent Thoracic Radiation for Patients With Unresectable Stage IIIA/IIIB Non-Small Cell Lung Cancer

Inclusion Criteria

Eligibility Criteria:

- Histologically confirmed unresectable non-small cell carcinoma of the lung
(adenocarcinoma, squamous cell carcinoma or anaplastic large cell carcinoma). See
below for TNM eligibility. Mediastinoscopy or thoracoscopy in patients with
mediastinal lymph node enlargement of < 2 cm on CT scans of suspicious on PET scan to
confirm suspected involvement. These staging procedures are not mandatory for
patients with obvious nodal involvement (2.0 cm or greater). Staging system: The
New International Staging System for lung cancer (Clifton F. Mountain, 1997) will be
followed. The following stages will be eligible:

- Patients with stage IIIa disease will be eligible if it is felt that they are not
candidates for possible resection following neo-adjuvant therapy (unresectable T3N1
or T1-3 primary tumors with metastasis limited to single station ipsilateral
mediastinal lymph nodes). Patients with stage IIIb disease without significant*
pleural effusion will be eligible. This includes patients with metastases to
contralateral mediastinal or supraclavicular nodes.

- Patients without significant pleural effusion will constitute those in whom 1) it is
seen on CT scan only or 2) does not reaccumulate after one thoracentesis and is
cytologically negative.

- No evidence of distant metastasis.

- Patients must have measurable disease by the Recist Evaluation Criteria in Solid
Tumors (RECIST) criteria. Baseline measurements/evaluations must be obtained within 4
weeks prior to registration.

- Patients must not have small cell carcinoma as part of the histological specimen
(World Health Organization [WHO] classification 22.40)

- Performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1 at time of
registration.

- Patients with preexisting clinically significant peripheral neuropathy are
ineligible.

- Weight loss of ≤ 5% in the preceding three months

- No prior systemic chemotherapy or thoracic radiotherapy.

- Patients must have adequate bone marrow reserve as determined by the following
laboratory values: Obtained within 14 days prior to registration.

- White blood cell count 4000/ul or greater and granulocyte count of 1500/ul or greater

- Platelet count of 100,000/ul or greater

- Hemoglobin of 10 gms/dl or greater.

- Adequate renal and liver function as determined by the following laboratory values:
Obtained within 14 days prior to registration.

- Serum creatinine < 1.5 mg/dl or creatinine clearance greater than 50 cc/min

- Bilirubin less than 1.5 mg/dl

- SGOT less than 1.5 times normal

- No history of a prior or concomitant malignancy in the past five years except for
surgically cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.

- No concomitant life threatening or uncontrolled serious medical illness such as
cardiac arrhythmia, end stage congestive heart failure, liver disease with
significant hepatic insufficiency, organic brain syndrome.

- Women of childbearing potential and sexually active males are strongly advised to use
an accepted and effective method of contraception.

- Age greater than or equal to 18 years

- Written, informed consent must be obtained prior to registration.