Docetaxel Intermittent-Erlotinib (Tarceva®) In Metastatic Non Small Cell Lung Cancer (NSCLC)

Sponsor
Hellenic Cooperative Oncology Group
Study ID
NCT00783471
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib, Docetaxel — DRUG
    Drug: Erlotinib 150 mg po daily, days 1-12 Drug: Docetaxel 75 mg/m2 IV over 30 min on day 15 Treatment will be repeated every 21 days
  • Docetaxel, Erlotinib — DRUG
    Drug: Docetaxel 75 mg/m2 IV over 30 min on day 1 Drug: Erlotinib 150 mg po daily, days 4-15 Treatment will be repeated every 21 days

Study Details

To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced Non-Small-Lung-Cancer

Key Dates

First listed
Oct 31, 2008
Start date
Nov 30, 2008
Status verified
Jun 2010
Primary completion
May 31, 2010
Completion
Jun 30, 2010

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Erlotinib followed by Docetaxel
  • Experimental: 2
    Docetaxel followed by Erlotinib

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: Assessment every 6 weeks ]

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