NCT00238849

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

October 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
Last Updated

October 14, 2005

Status Verified

October 1, 2005

First QC Date

October 12, 2005

Last Update Submit

October 13, 2005

Conditions

Previously Treated Metastatic Non-Small Cell Lung Cancer

Keywords

Non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Efficacy

Secondary Outcomes (4)

  • Time to progression

  • Duration of response

  • Survival

  • Toxicity profile

Interventions

OxaliplatinDRUG

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • Previously treated with Oxaliplatin or Navelbine
  • Symptomatic CNS metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Integrated Community Oncology Network

Jacksonville, Florida, 32256, United States

Location

Integrated Community Oncology Network

Orange Park, Florida, 32073, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Thomas A Marsland, MD

    Integrated Community Oncology Network

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane L Edwards, RN,OCN, CCRP

CONTACT

904-363-7471diane.edwards@foa.cc

Gloria Perez, RN, BSN, CCRP

CONTACT

904-739-7779gloria.perez@foa.cc

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 14, 2005

Last Updated

October 14, 2005

Record last verified: 2005-10

Locations

US(2)