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. )

First Received: December 20, 2005 Last Updated: April 3, 2007 History of Changes

Sponsors and Collaborators:	James Graham Brown Cancer Center University of Louisville Sanofi-Aventis
Information provided by:	James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:	NCT00268151

Purpose

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	Intervention	Phase
Carcinoma, Non-Small Cell Lung	Drug: Oxaliplatin Drug: Capecitabine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase I Study of Oxaliplatin (Eloxatin) and Capecitabine (Xeloda) and Concurrent Radiation Therapy (XELOX-RT) in Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy

Drug Information available for: Oxaliplatin Capecitabine

U.S. FDA Resources

Further study details as provided by James Graham Brown Cancer Center:

Estimated Enrollment:	24
Study Start Date:	February 2005

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268151

Locations

United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

James Graham Brown Cancer Center

University of Louisville

Sanofi-Aventis

Investigators

Principal Investigator:

Goetz H Kloecker, MD, MSPH

James Graham Brown Cancer Center/ University of Louisville

More Information

Additional Information:

James Graham Brown Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	562.04, OX-03-156
Study First Received:	December 20, 2005
Last Updated:	April 3, 2007
ClinicalTrials.gov Identifier:	NCT00268151 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by James Graham Brown Cancer Center:

non-small cell lung cancer
oxaliplatin
capecitabine
XELOX-RT

Study placed in the following topic categories:

Antimetabolites
Thoracic Neoplasms
Oxaliplatin
Capecitabine
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Thoracic Neoplasms
Respiratory Tract Neoplasms
Capecitabine
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pharmacologic Actions
Carcinoma

Neoplasms
Oxaliplatin
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009