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CompletedNCT00137800Updated Apr 3, 2020

Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients

A Phase 2 interventional study of OSI-774 (Tarceva) in Non-Small-Cell Lung Carcinoma, sponsored by Dana-Farber Cancer Institute. Completed at 2 sites in United States. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-03.

Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Feb 2003, registered Aug 2005).
Phase
Phase 2
Study type
Interventional
Enrollment
82
Allocation
Not applicable
Ages
70 Years and older
Sex
All
01

Study summary

The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and potentially as good as or better than standard chemotherapy drugs, when given to subjects with non-small cell lung cancer, who are 70 years of age or older.

Read the detailed description

Patients will receive OSI-774 once daily without interruption. There are no pre-determined number of cycles or planned dose interruptions. For the purposes of evaluation, toxicity and efficacy, a four week (28 day period) will be considered 1 cycle.

Patients will continue to receive OSI-774 until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study.

Patients will have radiographic evaluations after every two cycles of therapy. After cycle 2, patients will also be evaluated by FDG-PET scanning.

Patients will also be asked to fill out a Lung Cancer Symptom Scale (LCSS) on the first day of each cycle.

Bloodwork will also be performed on day 1 of each cycle as well as at the end of the study.

02

Conditions studied

  • Non-Small-Cell Lung Carcinoma

Keywords

  • Non-Small Cell Lung Cancer
  • Elderly Cancer Patients
  • Tarceva
  • Erlotinib
  • OSI-774
  • Stage IIIB or IV Non-Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 82 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age: 70 years of age or older
  • Stage IV or IIIB non-small cell lung cancer (NSCLC)
  • Measurable tumor(s)
  • Three or more weeks since prior radiation therapy
  • Three or more weeks since prior major surgery
  • Must at least be able to walk and capable of taking care of oneself although unable to carry out work activities.
  • Must be up and about more than 50% of waking hours.
  • Life expectancy of 8 weeks or more
  • Blood tests that show kidneys, liver and bone marrow to be working adequately
  • Completely healed from previous oncologic or other major surgery

Exclusion criteria

Exclusion Criteria:

  • Prior chemotherapy regimen for non-small cell lung cancer
  • Prior exposure to OSI-774 or similar treatments such as trastuzumab, ZD1839, C225, etc.
  • Uncontrolled central nervous system metastases
  • Concurrent active cancer
  • Malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
  • Prior chemotherapy for any malignant disease
  • Difficulty swallowing
  • A disease or disorder that interferes with ability to digest and absorb food
  • A medical condition that could make it unsafe for patient to participate in this study
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Tarceva

    Chemotherapy Single Agent Systemic

    Drug: OSI-774 (Tarceva)

Interventions

  • DrugOSI-774 (Tarceva)

    Once daily without interruption as long as there is no disease progression or serious side effects experienced.

06

What researchers measure

Primary outcomes

  1. To determine how well non-small cell lung cancer cells in the body respond to OSI-774

    Time frame: 2 years

  2. To determine the survival rate of patients treated with OSI-774

Secondary outcomes

  1. To determine the safety of OSI-774 in people 70 years of age or older

    Time frame: 2 years

  2. To see how OSI-774 affects overall quality of life

    Time frame: 2 years

07

Study locations

2 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
08

References and documents

Publications

  • Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753. PubMed 16014882 ↗
  • Perez-Soler R, Chachoua A, Hammond LA, Rowinsky EK, Huberman M, Karp D, Rigas J, Clark GM, Santabarbara P, Bonomi P. Determinants of tumor response and survival with erlotinib in patients with non--small-cell lung cancer. J Clin Oncol. 2004 Aug 15;22(16):3238-47. doi: 10.1200/JCO.2004.11.057. PubMed 15310767 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00137800
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Brigham and Women's Hospital, Genentech, Inc.
Responsible party
Pasi A. Janne, MD, PhD (Associate Professor, Medicine, Dana-Farber Cancer Institute) — Principal investigator
First posted
Aug 30, 2005
Start date
Feb 2003
Primary completion
May 2005
Completion
Mar 2007
Last update
Apr 3, 2020

Study contacts

Pasi A Janne, MD, PhD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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