Oxaliplatin in Combination With Capecitabine and Concurrent Radiation Therapy in Non-Small Cell Lung Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00268151
(Study was terminated due to lack of funding.)
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.
Condition or disease
Carcinoma, Non-Small Cell Lung
Drug: OxaliplatinDrug: Capecitabine
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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