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

Phase II Study of Oxaliplatin in Combination With Navelbine for the Second-Line Treatment of Advanced and Metastatic Non-Small Cell Lung Cancer

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00238849
Enrollment
40
Registered
2005-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2005-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously Treated Metastatic Non-Small Cell Lung Cancer

Keywords

Non-small cell lung cancer

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.

Interventions

DRUGOxaliplatin

Sponsors

Sanofi
CollaboratorINDUSTRY
Integrated Community Oncology Network
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Efficacy

Secondary

MeasureTime frame
Time to progression
Duration of response
Survival
Toxicity profile

Countries

United States

Contacts

Primary ContactDiane L Edwards, RN,OCN, CCRP
diane.edwards@foa.cc904-363-7471
Backup ContactGloria Perez, RN, BSN, CCRP
gloria.perez@foa.cc904-739-7779

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026