Study of OSI-774 (Tarceva) in Previously Untreated Elderl... | NCT00137800

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

NCT00137800

Sponsor

Dana-Farber Cancer Institute

Status

Completed

Last Update Posted

Apr 3, 2020Actual

Enrollment

82Actual

Phase

Phase 2

Conditions

Non-Small-Cell Lung Carcinoma

Interventions

OSI-774 (Tarceva)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003Actual

Primary Completion Date

May 2005Actual

Completion Date

Mar 2007Actual

First Submitted Date

Aug 29, 2005

First Submission Date that Met QC Criteria

Aug 29, 2005

First Posted Date

Aug 30, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2020

Last Update Posted Date

Apr 3, 2020Actual

Name	Class
Massachusetts General Hospital	OTHER
Brigham and Women's Hospital	OTHER
Genentech, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tarceva	Experimental	Chemotherapy Single Agent Systemic	Drug: OSI-774 (Tarceva)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OSI-774 (Tarceva)	Drug	Once daily without interruption as long as there is no disease progression or serious side effects experienced.	Tarceva

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine how well non-small cell lung cancer cells in the body respond to OSI-774		2 years
To determine the survival rate of patients treated with OSI-774

Secondary Outcomes

Measure	Description	Time Frame
To determine the safety of OSI-774 in people 70 years of age or older		2 years
To see how OSI-774 affects overall quality of life		2 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pasi A Janne, MD, PhD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States
Dana-Farber Cancer Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16014882	Background	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.
15310767

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds