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

NCT ID: NCT00238849

Last Updated: 2005-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Previously Treated Metastatic Non-Small Cell Lung Cancer

Keywords

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Non-small cell lung cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Oxaliplatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Integrated Community Oncology Network

OTHER

Sponsor Role lead

Principal Investigators

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Thomas A Marsland, MD

Role: PRINCIPAL_INVESTIGATOR

Integrated Community Oncology Network

Locations

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Integrated Community Oncology Network

Jacksonville, Florida, United States

Site Status

Integrated Community Oncology Network

Orange Park, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Diane L Edwards, RN,OCN, CCRP

Role: CONTACT

Phone: 904-363-7471

Email: [email protected]

Gloria Perez, RN, BSN, CCRP

Role: CONTACT

Phone: 904-739-7779

Email: [email protected]

Facility Contacts

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Diane Edwards, RN,OCN,CCRP

Role: primary

Gloria Perez, RN,BSN,OCN

Role: backup

Carla Malott, RN

Role: primary

Joan Ollie, BSN, RN

Role: backup

Other Identifiers

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ELVIS II

Identifier Type: -

Identifier Source: secondary_id

OX-03-087

Identifier Type: -

Identifier Source: org_study_id