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



Status:Terminated
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:February 2005

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Phase I Study of Oxaliplatin (Eloxatin) and Capecitabine (Xeloda) and Concurrent Radiation Therapy (XELOX-RT) in Non-Small Cell Lung Cancer

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.

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.

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
We found this trial at
1
site
529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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