Phase I Study of Oxaliplatin (Eloxatin) and Capecitabine (Xeloda) and Concurrent Radiation Therapy (XELOX-RT) in Non-Small Cell Lung Cancer

University of Louisville1 site in 1 country24 target enrollmentFebruary 2005

ConditionsCarcinoma, Non-Small Cell Lung

DrugsOxaliplatin Capecitabine

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Carcinoma, Non-Small Cell Lung
Sponsor: University of Louisville
Enrollment: 24
Locations: 1
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the most suitable dose of Oxaliplatin that can be safely given in combination with a low fixed dose of Capecitabine and a limited volume of radiation in patients with non-small cell lung cancer.

Detailed Description

The purpose of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of Oxaliplatin in combination with Capecitabine and radiation in subjects with non-small cell lung cancer.

Registry

clinicaltrials.gov

Start Date

February 2005

End Date

February 2007

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Louisville

Responsible Party

Principal Investigator

Goetz Kloecker

Associate Professor

University of Louisville

Eligibility Criteria

Inclusion Criteria

•histologically proven non-small cell lung cancer
•inoperable Stage III A or B NSCLC
•must have measurable disease by RECIST criteria
•no more than one prior chemotherapy for advanced disease
•ECOG Performance Status of 0, 1, or 2
•must be able to swallow pills or have a working gastric feeding tube and no evidence of malabsorption
•negative serum beta-HCG test and under active contraception (for females of childbearing potential)
•no known allergies to any of the study drugs
•willingness to sign an informed consent

Exclusion Criteria

•women who are pregnant or breastfeeding
•ANC of less than 1500/mm3
•platelet count of less than 100,000/mm3
•estimated creatinine clearance of less than 50 cc/min (as measured by the Cockcroft-Gault equation)
•bilirubin of less than 2mg/dl
•SGPT of greater than 2x nl
•peripheral neuropathy of Grade 2 or higher
•more than one previous chemotherapy and previous radiation therapy to the chest
•a history of CHF/MI or other significant cardiac history within the last six months