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

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Oxaliplatin

Capecitabine

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small Cell Lung focused on measuring non-small cell lung cancer, oxaliplatin, capecitabine, XELOX-RT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

James Graham Brown Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00268151

First Posted

December 20, 2005

Last Updated

March 1, 2018

Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center, Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00268151

Brief Title

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

Official Title

Phase I Study of Oxaliplatin (Eloxatin) and Capecitabine (Xeloda) and Concurrent Radiation Therapy (XELOX-RT) in Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Terminated

Why Stopped

Study was terminated due to lack of funding.

Study Start Date

February 2005 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center, Sanofi

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small Cell Lung

Keywords

non-small cell lung cancer, oxaliplatin, capecitabine, XELOX-RT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Type

Drug

Intervention Name(s)

Capecitabine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Goetz H Kloecker, MD, MSPH

Organizational Affiliation

James Graham Brown Cancer Center/ University of Louisville

Official's Role

Principal Investigator

Facility Information:

Facility Name

James Graham Brown Cancer Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.browncancercenter.org

Description

James Graham Brown Cancer Center

Carcinoma, Non-Small Cell Lung

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial