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Individualized Therapy Based of Tumoral mRNA Levels of ERCC1, RRM1 and BRCA1 in Advanced Non-Small-Cell Lung Cancer

NCT00705549 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2013-02-13

No results posted yet for this study

Summary

This is a prospective pilot phase II trial, in patients with wet stage IIIb and IV NSCLC using chemotherapy regimens which will be defined according to the pharmacogenomic profile (tumoral expression of ERCC1, BRCA1 and RRM1) of the tumor cells.

Conditions

  • Non-Small-Cell Lung Cancer

Interventions

DRUG

Gemcitabine

Gemcitabine I.V at the dose of 1000mg/m2 on Day 1 and Day 8

DRUG

Cisplatin

Cisplatin I.V at the dose of 75mg/m2 on Day 1

DRUG

Docetaxel

Docetaxel I.V at the dose of 75mg/m2 on Day 1

DRUG

Cisplatin

Cisplatin I.V at the dose of 80mg/m2 on Day 1

DRUG

Vinorelbine

Vinorelbine per os 50mg every Monday, Wednesday and Friday

DRUG

Pemetrexate

Pemetrexate I.V 500mg/m2 on Day 1

Sponsors & Collaborators

  • University Hospital of Crete

    collaborator OTHER

  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

  • John Souglakos, MD · University Hospital of Crete, Dep of Medical Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Greece

Study Locations

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Entities

Drugs

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 NCT00705549 on ClinicalTrials.gov