Ph I/II Nab-Paclitaxel & Carboplatin w/Concurrent Radiation Therapy for Unresectable Stg III NSCLC

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) may make tumor cells more sensitive to radiation therapy. Giving nab-paclitaxel together with radiation therapy and carboplatin may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving nab-paclitaxel together with carboplatin and radiation therapy and to see how well it works in treating patients with stage III non-small-cell lung cancer that cannot be removed by surgery.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria for Phase I and Phase II Patients:

• Patients must voluntarily sign and date an informed consent before the initiation of any study procedures

• Patients must have non-metastatic, inoperable, Stage IIIA or IIIB histologically or cytologically documented NSCLC without evidence of malignant pleural effusion

• Patients must not have received any prior systemic chemotherapy, thoracic radiotherapy or surgical resection for treatment of NSCLC

• Patients must have at least one site of unidirectionally measurable disease as defined by Response Evaluation in Solid Tumors (RECIST) criteria

• Patients must be ≥ 3 weeks from a formal exploratory thoracotomy

• Patients must have a Radiation Oncology and Medical Oncology consult and approval prior to study entry

• Patients must be ≥ 18 years of age

• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Women of childbearing potential must have a negative baseline serum pregnancy or a negative urine pregnancy test within 7 days prior to Week 1, Day 1 and must not be breast feeding.

• Women of childbearing potential and men with a sexual partner of child bearing potential must use an effective method of contraception beginning prior to study entry, for the duration of the study participation and for a minimum of 3 months after the last dose of chemotherapy.

• Patients must have adequate hepatic, renal, lung and bone marrow function as defined below:

• Absolute neutrophil count (ANC) ≥1,500/mm3

• Hemoglobin ≥ 9.0 gm/dL

• Serum Creatinine ≤1.5mg/dl

• Platelets > 100,000/mm3

• Total bilirubin ≤ upper limit of normal

• AST and ALT < 2.5 X upper limit of normal

• Alkaline phosphatase < 2.5 X upper limit of normal

• Calculated CrCl > 45 ml/min (via Cockroft-Gault formula)

• Forced expiratory volume in 1 second (FEV 1) > 800 ml

Exclusion Criteria for Phase I and Phase II Patients:

• Known hypersensitivity to carboplatin or nab-paclitaxel

• Peripheral neuropathy Grade ≥ 2

• Wet stage IIIB (documented malignant pleural effusion) or stage IV NSCLC

• Previous chemotherapy or radiation therapy to the chest

• Any concomitant malignancy or brain metastasis

• Any uncontrolled, clinically significant medical or psychiatric disorder

• Pregnant or nursing women

• A greater than or equal to 10% weight loss over the past 3 months