Study of Erlotinib With Docetaxel in Selected Non Small Cell Lung Cancer Patients in First Line Treatment

Sponsor
Meir Medical Center
Study ID
NCT00840125
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • erlotinib — DRUG
    150mg tablet daily
  • docetaxel — DRUG
    30 mg/m2 days 1,8 of 22 days cycles, up to 6 cycles

Study Details

Study Rationale: There is increasing evidence that erlotinib improves overall survival in selected patients with stage IIIB-IV NSCLC. Furthermore, pre-clinical and phase II studies have shown a potential for synergism between erlotinib and docetaxel. This study will further evaluate the effects of combination treatment on overall survival in selected NSCLC patient population. Based on recent published data, the treatment cycle in this study will be 22 days with two infusions (Day 1 and Day 8 of each cycle). This is different from the standard therapy care of 28-day cycle (three infusions on Days 1, 8 and 15). The shorter 22-day cycle was shown to be just as effective as the 28-day cycle and is expected to increase subject compliance and decrease chemotherapy-induced toxicity. Study Objectives: The primary objective is to demonstrate superiority in progression-free-survival, when erlotinib is added to docetaxel. The secondary objectives are to determine: * Overall survival (defined as the time period from the start of first-line therapy to death) * Time to treatment failure or disease progression (defined as the time period from the start of first-line therapy to investigator assessed disease progression) * Tumor response rate and duration * Safety profile * Quality of Life improvement * microRNA profile (assessed from human lung biopsy and/or cytology samples) at screening for prognostic purposes

Key Dates

First listed
Feb 10, 2009
Start date
Feb 28, 2009
Status verified
Oct 2012
Primary completion
Dec 31, 2010
Completion
Aug 31, 2011

Study Design

Enrollment
4 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    docetaxel + erlotinib

Primary Outcome Measure

all cause mortality [ Time Frame: 1 year ]

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