Clinical Trials /

OSI-774 (Erlotinib, Tarceva) in Elderly Patients

NCT00200395

Description:

The purpose of this research study is to determine if OSI-774 (Tarceva) is effective in the treatment of non-small cell lung cancer and to further study its side effects. The investigators would also like to estimate disease-related symptom improvement rates using a questionnaire.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT00200395

Trial Eligibility

Document

Title

  • Brief Title: OSI-774 (Erlotinib, Tarceva) in Elderly Patients
  • Official Title: Phase II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients With Advanced Stage or Inoperable Non Small Cell Lung Cancer (NSCLC)

Clinical Trial IDs

  • ORG STUDY ID: 03-01-019
  • NCT ID: NCT00200395

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
TarcevaOSI-774, ErlotinibOSI-774 (Tarceva)

Purpose

The purpose of this research study is to determine if OSI-774 (Tarceva) is effective in the treatment of non-small cell lung cancer and to further study its side effects. The investigators would also like to estimate disease-related symptom improvement rates using a questionnaire.

Detailed Description

      In recent years, it has been shown that the degree of improvement achievable with
      chemotherapy has plateaued with the use of chemotherapy doublets. The presence of co-morbid
      conditions and poor performance status may preclude the use of chemotherapy in many elderly
      patients, which even in the medically fit, has modest benefits. The advent of targeted cancer
      therapy with the discovery of tyrosine kinases as mediators of tumor growth, with its limited
      toxicity profile, offers a promising approach to the treatment of NSCLC, in particular to the
      elderly subset of patients. The encouraging results from the other trials provide a strong
      rationale to evaluate an oral EGFR-tyrosine kinase inhibitor OSI-774 in patients with
      advanced and inoperable NSCLC over the age of 70. In vitro and clinical data suggest a dose-
      dependent response with Tarceva (Genentech, data on file).

Trial Arms

NameTypeDescriptionInterventions
OSI-774 (Tarceva)ExperimentalOral treatment with OSI-774 (Tarceva) will be given as a 150 mg tablets daily for 14 days. On day 15 and if there are no adverse effects the dose will be increased to 200 mg.
  • Tarceva

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have confirmed non-small cell lung cancer. Age > 65 years Patients must
             have adequate organ and marrow function

        Exclusion Criteria:

          -  Patients who have had prior chemotherapy will be excluded. Patients may not be
             receiving any other investigational agents.
Maximum Eligible Age:N/A
Minimum Eligible Age:65 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Rate of Response
Time Frame:1-3 years
Safety Issue:
Description:The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date the recurrent or progressive disease is documented.

Secondary Outcome Measures

Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v2.0
Time Frame:1-3 years
Safety Issue:
Description:
Measure:Changes in Quality of Life (QOL): questionnaire
Time Frame:through study completion, an average of 3 years
Safety Issue:
Description:This will involve participant response to a seven-item lung cancer subscale of Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire.
Measure:Rate of Progression free survival
Time Frame:1-3 years
Safety Issue:
Description:Progression free survival is defined as the duration of time from start of treatment to time of progression.
Measure:Duration of stable disease
Time Frame:1-3 years
Safety Issue:
Description:Stable disease is measured from the start of the treatment until the criteris for progression are met., taking as reference the smallest measurements recorded since the treatment started.
Measure:Overall Rate of Survival
Time Frame:Up to 5 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Montefiore Medical Center

Last Updated

December 30, 2019