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

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00705549
Phase
PHASE2
Status
Terminated

Conditions

  • Non-Small-Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Gemcitabine I.V at the dose of 1000mg/m2 on Day 1 and Day 8
  • Cisplatin — DRUG
    Cisplatin I.V at the dose of 75mg/m2 on Day 1
  • Docetaxel — DRUG
    Docetaxel I.V at the dose of 75mg/m2 on Day 1
  • Cisplatin — DRUG
    Cisplatin I.V at the dose of 80mg/m2 on Day 1
  • Vinorelbine — DRUG
    Vinorelbine per os 50mg every Monday, Wednesday and Friday
  • Pemetrexate — DRUG
    Pemetrexate I.V 500mg/m2 on Day 1

Study Details

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.

Key Dates

Start date
Feb 29, 2008
Status verified
Feb 2013
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
88 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Gemzar/Cisplatin
  • Experimental: 2
    Taxotere/Cisplatin
  • Experimental: 3
    Cisplatin/Navelbine metronomic
  • Experimental: 4
    Taxotere/Gemzar
  • Experimental: 5
    Gemzar
  • Experimental: 6
    Taxotere
  • Experimental: 7
    Navelbine metronomic
  • Experimental: 8
    Alimta/Cisplatin
  • Experimental: 9
    Alimta/Gemzar
  • Experimental: 10
    Taxotere
  • Experimental: 11
    Alimta

Primary Outcome Measure

Objective Response Rate (ORR) based on the pharmacogenomic profile of the ERCC1, RRM1 and BRCA1 expression [ Time Frame: Objective responses confirmed by CT or MRI ]

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