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

Carcinoma, Non-Small Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00268151
• Other study ID #: 562.04
• Secondary ID: OX-03-156
• Status: Terminated
• Phase: Phase 1
• First received: December 20, 2005
• Last updated: March 1, 2018
• Start date: February 2005

Study information

• Verified date: March 2018
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small Cell Lung
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• Oxaliplatin

• Capecitabine

Locations

Country	Name	City	State
United States	James Graham Brown Cancer Center	Louisville	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
University of Louisville	James Graham Brown Cancer Center, Sanofi

Country where clinical trial is conducted

United States, 

External Links

•   James Graham Brown Cancer Center