Erlotinib (Tarceva (Trademark), OSI-774) in Treating Pati... | NCT00072631

Studies
Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer

NCT00072631

Sponsor

OSI Pharmaceuticals

Status

Completed

Last Update Posted

Feb 8, 2018Actual

Enrollment

43Actual

Phase

Phase 2

Conditions

Advanced Non Small Cell Lung Cancer
Failed Prior Chemotherapy

Interventions

Tarceva (Trademark) (erlotinib HCl, OSI-774)

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

ID	Type	Description	Link
Dose to Rash

Status Module

Record Verification Date

Jun 2015

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

Nov 5, 2003Actual

Primary Completion Date

Mar 14, 2007Actual

Completion Date

Mar 14, 2007Actual

First Submitted Date

Nov 5, 2003

First Submission Date that Met QC Criteria

Nov 6, 2003

First Posted Date

Nov 7, 2003Estimated

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

Feb 6, 2018

Last Update Posted Date

Feb 8, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.

Detailed Description

Only patients with 0 to 1 performance status on the ECOG scale are eligible.

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

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 erlotinib	Experimental		Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tarceva (Trademark) (erlotinib HCl, OSI-774)	Drug	Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash	1 erlotinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate		3 years

Secondary Outcomes

Measure	Description	Time Frame
Feasibility of correlating objective response rate and duration of response to grade of rash		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological).
Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer.
Measurable disease per RECIST criteria.
Adequate bone marrow, hepatic and renal function.

Exclusion Criteria:

Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years.
Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days.
Known hypersensitivity to minocycline.
History of serious cardiac disease that is not controlled.
Serious eye conditions.
Prior treatment with inhibitors of EGFR of any kind.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Drug Development Cancer Therapy and Research Center		San Antonio	Texas	78229	United States

Label	URL
Link to results on Astellas Clinical Study Results website	View source

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069347	Erlotinib Hydrochloride
D010330	Patents as Topic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided