Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma

Sponsor
Spanish Lung Cancer Group
Study ID
NCT00883480
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Docetaxel — DRUG
    Docetaxel 75 mg/day 1 x 4 cycles
  • Cisplatin — DRUG
    Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles
  • Gemcitabine — DRUG
    Cisplatin 75 mg/ day 1 x 4 cycles Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles
  • Erlotinib — DRUG
    Erlotinib 150 mg/day x 21 days

Study Details

This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.

Key Dates

First listed
Apr 17, 2009
Start date
Jun 30, 2005
Status verified
Jun 2022
Primary completion
Jan 31, 2008
Completion
Nov 30, 2008

Study Design

Enrollment
153 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: 2
    The rest of the patients who do not carry the Factor Receptor mutation of Epidermal Growth will receive chemotherapy treatment individualized based on BRCA 1 m RNA levels. Function of these levels, three different subgroups of treatment: Subgroup A with low BRCA1 mRNA levels will receive treatment with gemcitabine / cisplatin Subgroup B with intermediate levels of BRCA1 mRNA: will receive treatment with docetaxel / cisplatin Subgroup C with high levels of BRCA1 mRNA: will receive treatment with docetaxel
  • Experimental: 1
    The group of patients carrying EGFR mutation will receive treatment with Erlotinib, a selective oral Receptor tyrosine kinase inhibitor Epidermal Growth Factor

Primary Outcome Measure

Tumoral Response (RECIST criteria) [ Time Frame: From date of end of experimental treatment until the date of last follow up, assessed up to 24 months] ]

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