Phase II Study of Oxaliplatin and Navelbine for Second-Li... | NCT00238849

Studies
Phase II Study of Oxaliplatin and Navelbine for Second-Line Treatment of Advanced NSCLC.

NCT00238849

Sponsor

Integrated Community Oncology Network

Status

Unknown status

Last Update Posted

Oct 14, 2005Estimated

Enrollment

Phase

Phase 2

Conditions

Previously Treated Metastatic Non-Small Cell Lung Cancer

Interventions

Oxaliplatin

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
ELVIS II

Status Module

Record Verification Date

Oct 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 12, 2005

First Submission Date that Met QC Criteria

Oct 13, 2005

First Posted Date

Oct 14, 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

Oct 13, 2005

Last Update Posted Date

Oct 14, 2005Estimated

Name	Class
Sanofi	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to determine the response rate to treatment with oxaliplatin and Navelbine in patients with previously treated NSCLC. Oxaliplatin and Navelbine have not been clinically evaluated yet. However, Navelbine has been safely administered with other platinum compounds.

Detailed Description

This is a non-randomized trial for patients with previously treated Non-small cell lung cancer. Each patient will receive 6 cycles of chemotherapy consisting of Oxaliplatin and Navelbine. Oxaliplatin is given intravenously every 21 days and Navelbine is administered Intravenously on day 1 and day 8 every 21 days.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Oxaliplatin	Drug

Measure	Description	Time Frame
Efficacy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Locally advanced or metastatic non-small cell lung cancer that has recurred, progressed, or failed to respond to previous systemic chemo.
Measurable disease
Good performance status (ECOG 0,1 or 2)

Exclusion Criteria:

Previously treated with Oxaliplatin or Navelbine
Symptomatic CNS metastases

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

Name	Role	Phone	Extension	Email
Diane L Edwards, RN,OCN, CCRP	Contact	904-363-7471		diane.edwards@foa.cc
Gloria Perez, RN, BSN, CCRP	Contact	904-739-7779		gloria.perez@foa.cc

Overall Officials

Name	Affiliation	Role
Thomas A Marsland, MD	Integrated Community Oncology Network	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Integrated Community Oncology Network		Jacksonville	Florida	32256	United States

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

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided