Oxaliplatin in Combination With Capecitabine and Concurre... | NCT00268151

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

NCT00268151

Sponsor

University of Louisville

Status

Terminated

Last Update Posted

Mar 5, 2018Actual

Enrollment

Phase

Phase 1

Conditions

Carcinoma, Non-Small Cell Lung

Interventions

Oxaliplatin
Capecitabine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
OX-03-156

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was terminated due to lack of funding.

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Feb 2007Actual

Completion Date

Not provided

First Submitted Date

Dec 20, 2005

First Submission Date that Met QC Criteria

Dec 20, 2005

First Posted Date

Dec 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2018

Last Update Posted Date

Mar 5, 2018Actual

Name	Class
James Graham Brown Cancer Center	OTHER
Sanofi	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Goetz H Kloecker, MD, MSPH	James Graham Brown Cancer Center/ University of Louisville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
James Graham Brown Cancer Center		Louisville	Kentucky	40202	United States

Label	URL
James Graham Brown Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077150	Oxaliplatin
D000069287	Capecitabine

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D003841	Deoxycytidine
D003562	Cytidine

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Oxaliplatin	Drug
Capecitabine	Drug