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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small Cell Lung

Thank you

Trial Information

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 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Goetz H Kloecker, MD, MSPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center/ University of Louisville

Authority:

United States: Food and Drug Administration

Study ID:

562.04

NCT ID:

NCT00268151

Start Date:

February 2005

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • non-small cell lung cancer
  • oxaliplatin
  • capecitabine
  • XELOX-RT
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

James Graham Brown Cancer CenterLouisville, Kentucky  40202