Oxaliplatin in Combination With Capecitabine and Concurrent Radiation Therapy in Non-Small Cell Lung Cancer

University of Louisville (UOFL)

Status and phase

Terminated

Phase 1

Conditions

Carcinoma, Non-Small Cell Lung

Treatments

Drug: Capecitabine

Drug: Oxaliplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00268151

562.04

OX-03-156

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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