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

NCT00840125 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2012-10-30

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

erlotinib

150mg tablet daily

DRUG

docetaxel

30 mg/m2 days 1,8 of 22 days cycles, up to 6 cycles

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Principal Investigators

  • Maya Gottfried, MD · Meir Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-12-31
Completion
2011-08-31

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

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 NCT00840125 on ClinicalTrials.gov