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

Stopped early · Phase 1

Conditions studied: Carcinoma, Non-Small Cell Lung

In brief

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.

Key facts

Study ID

NCT00268151

Run by

University of Louisville

People needed

24

Starts

2005-02-01

Last updated by the study team

2018-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• James Graham Brown Cancer Center — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.