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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

OSI-774 (Tarceva)

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Carcinoma focused on measuring Non-Small Cell Lung Cancer, Elderly Cancer Patients, Tarceva, Erlotinib, OSI-774, Stage IIIB or IV Non-Small Cell Lung Cancer

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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: 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

Sites / Locations

Massachusetts General Hospital
Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tarceva

Arm Description

Chemotherapy Single Agent Systemic

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

To see how OSI-774 affects overall quality of life

Full Information

NCT ID

NCT00137800

First Posted

August 29, 2005

Last Updated

April 1, 2020

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital, Brigham and Women's Hospital, Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00137800

Brief Title

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

Official Title

A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

February 2003 (Actual)

Primary Completion Date

May 2005 (Actual)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital, Brigham and Women's Hospital, Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tarceva

Arm Type

Experimental

Arm Description

Chemotherapy Single Agent Systemic

Intervention Type

Drug

Intervention Name(s)

OSI-774 (Tarceva)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

2 years

Title

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

Secondary Outcome Measure Information:

Title

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

Time Frame

2 years

Title

To see how OSI-774 affects overall quality of life

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pasi A Janne, MD, PhD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16014882

Citation

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.

Results Reference

background

PubMed Identifier

15310767

Citation

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.

Results Reference

background

Links:

URL

https://www.dana-farber.org/thoracic-lung-cancer-treatment-center/

Description

Dana-Farber Cancer Institute Lowe Thoracic Oncology Program

Non-Small-Cell Lung Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial