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

TerminatedPhase 1

Sponsor: University of Louisville

Conditions: Carcinoma, Non-Small Cell Lung

Interventions: Oxaliplatin, Capecitabine

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Louisville, Kentucky, United States