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

This study has been terminated.
(Study was terminated due to lack of funding.)
Sponsor:
Collaborators:
University of Louisville
Sanofi
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00268151
First received: December 20, 2005
Last updated: May 2, 2013
Last verified: May 2013
History of Changes

December 20, 2005
May 2, 2013
February 2005
February 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00268151 on ClinicalTrials.gov Archive Site
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Oxaliplatin in Combination With Capecitabine and Concurrent Radiation Therapy in Non-Small Cell Lung Cancer
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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small Cell Lung
  • Drug: Oxaliplatin
  • Drug: Capecitabine
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
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February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00268151
562.04, OX-03-156
Not Provided
James Graham Brown Cancer Center
James Graham Brown Cancer Center
  • University of Louisville
  • Sanofi
Principal Investigator: Goetz H Kloecker, MD, MSPH James Graham Brown Cancer Center/ University of Louisville
James Graham Brown Cancer Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP