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TERMINATEDPHASE1

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

NCT00268151•University of Louisville

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Key Dates

Start Date

February 1, 2005

Primary Completion Date

February 1, 2007

Last Updated

March 5, 2018

Enrollment

Estimated participants

Conditions

Carcinoma, Non-Small Cell Lung

Interventions

Oxaliplatin

DRUG

Capecitabine

DRUG

A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors

NCT06549816

Carcinoma, Non-Small Cell LungSquamous Cell Carcinoma of Head and Neck+4 more

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WITHDRAWNPHASE1/PHASE2

A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy

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Carcinoma, Non-small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors

A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy

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