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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James Graham Brown Cancer Center; University of Louisville
• Collaborators: James Graham Brown Cancer Center; Sanofi; University of Louisville
• Treatments: Capecitabine; Oxaliplatin

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