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

March 1, 2018 updated by: Goetz Kloecker, University of Louisville

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

Sanofi
James Graham Brown Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

December 20, 2005

First Submitted That Met QC Criteria

December 20, 2005

First Posted (Estimate)

December 22, 2005

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 562.04
  • OX-03-156

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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