NCT00268151

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

March 5, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

December 20, 2005

Last Update Submit

March 1, 2018

Conditions

Carcinoma, Non-Small Cell Lung

Keywords

non-small cell lung canceroxaliplatincapecitabineXELOX-RT

Interventions

OxaliplatinDRUG
CapecitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

OxaliplatinCapecitabine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Goetz H Kloecker, MD, MSPH

    James Graham Brown Cancer Center/ University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 22, 2005

Study Start

February 1, 2005

Primary Completion

February 1, 2007

Last Updated

March 5, 2018

Record last verified: 2018-03

Locations

US(1)