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
  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 1

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


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

Estimated Enrollment: 24
Study Start Date: February 2005
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Goetz H Kloecker, MD, MSPH James Graham Brown Cancer Center/ University of Louisville
  More Information

Additional Information:
No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00268151     History of Changes
Other Study ID Numbers: 562.04, OX-03-156
Study First Received: December 20, 2005
Last Updated: May 2, 2013
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Capecitabine
Fluorouracil
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014