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Gemcitabine Plus Oxaliplatin in Advanced Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

NCT00453115 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2010-10-25

No results posted yet for this study

Summary

Oxaliplatin is a diaminocyclohexane platinum compound, with a mechanism of action similar to that of cisplatin. Oxaliplatin has a more manageable toxicity profile than cisplatin, with no renal toxicity and a lower incidence of hematological and gastrointestinal toxicities. Gemcitabine and oxaliplatin are both active in NSCLC with no overlapping toxicity. Preclinical studies show a synergistic effect of the gemcitabine-oxaliplatin combination. The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index.

Conditions

Interventions

DRUG

Oxaliplatin

oxaliplatin 85mg/m2 iv on D1 and 15, every 4 weeks until disease progression

DRUG

Gemcitabine

gemcitabine 1250mg/m2 iv on day 1 and 15, every 4 weeks until disease progression

Sponsors & Collaborators

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Heung Tae Kim, M.D. · National Cancer Center, Korea

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-05-31
Completion
2011-05-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00453115 on ClinicalTrials.gov