A RANDOMIZED PHASE I/II STUDY OF NAB-PACLITAXEL, OR PACLITAXEL, PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY FOLLOWED BY CONSOLIDATION IN PATIENTS WITH FAVORABLE PROGNOSIS INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)
- Clements University Hospital
We propose this phase i/ii study to use weekly nab-Paclitaxel (abraxane) and carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no published human studies combining nab-Paclitaxel (abraxane) with radiation. We will first confirm the tolerated dose (TD) of concurrent nab-Paclitaxel (abraxane) at 50mg/m2, and then will begin enrolling patients into the phase ii component using either nab-Paclitaxel (abraxane) at the TD with carboplatin concurrent with daily radiation or paclitaxel with with carboplatin concurrent with daily radiation.
3.1.1 Histologically or cytologically documented NSCLC, including squamous cell carcinoma, adenocarcinoma (including bronchioloalveolar carcinoma), and large cell anaplastic carcinoma (including giant and clear cell carcinomas) and poorly differentiated (not otherwise specified, NOS) non-small cell lung cancer; totally resected tumors are excluded.
* Patients must be M0;
* Patients with T1 or T2 disease with N2 or T3N1-2 disease (Stage IIIA) are eligible.
* Patients with T4 with any N or any T with N3 disease are eligible (Stage IIIB).
* Measurable disease is required. See Section 10.4 for RECIST definitions of measurable disease.
3.1.2 Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. The boost volume must be limited to < 50% of the ipsilateral lung volume.
3.1.3 Patients must be [CUBED]18 years of age
3.1.4 Patients with Zubrod performance status 0-1 (See Appendix A)
3.1.5 Adequate hematologic function defined as: ANC [CUBED] 1,000/mm3, platelets [CUBED] 100,000/mm3, and hemoglobin [CUBED] 9 g/dL (prior to transfusions); adequate hepatic function defined as: total bilirubin <= 1.5 x upper limit of normal (ULN), AST/SGOT and ALT/SGPT <= 2.5 x ULN, adequate renal function defined as Creatinine clearance > 30 mL/minute (calculated by Cockcroft-Gault formula), a serum creatinine level <= 1.5 mg/dL alkaline phosphatase <= 2.5 x ULN, glucose <= 2 x ULN
3.1.6 FEV1 with >= 1200 cc or >= 50% predicted
3.1.7 Patients with weight loss <= 10% over the past 3 months
3.1.8 Patients with a pleural effusion that is a transudate, cytologically negative and non-bloody are eligible if the radiation oncologists feel the tumor can still be encompassed within a reasonable field of radiotherapy (See Sections 6.4 and 6.5). If a pleural effusion can be seen on the chest CT but is too small to tap, the patient is eligible.
3.1.9 Patients who have recovered from exploratory thoracotomy
3.1.10 Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to registration
3.1.11 Pretreatment evaluations required for eligibility include:
* A medical history, physical examination, assessment of Zubrod performance status within 4 weeks prior to study entry;
* CBC with differential and platelet count, and laboratory profile must be completed within 4 weeks prior to study entry;
* FEV1, CT scan or MRI of the chest, a bone scan (or PET or PET/CT), and a CT scan or MRI of the brain (to rule out brain metastasis) within 6 weeks prior to study entry;
* For women of childbearing potential, a serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) must be performed within 7days prior to the start of protocol treatment;
* Medical Oncology and Radiation Oncology consults and approval.
3.1.12 Patients must sign a study-specific consent form prior to study entry.