Tarceva Surgery for Resectable Stage IIIA(N2) and IIIB (T4 N2) Non-Small-Cell Lung Cancer

This study has been terminated.

( Low accrual rate )

Study NCT00063258 Information provided by M.D. Anderson Cancer Center

First Received on June 24, 2003. Last Updated on May 5, 2011 History of Changes

Results First Received: August 25, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Lung Cancer
Interventions:	Drug: Tarceva (OSI-774) Drug: Paclitaxel Drug: Carboplatin

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 10/13/2003 to 03/18/2008; All patients recruited at University of Texas M.D. Anderson Cancer Center

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study terminated due to low accrual; No evaluable patients were assigned to Chemotherapy Alone group (anticipated randomization to have been 10 of 40 patients treated with 3 courses of chemotherapy).

Reporting Groups

	Description
Chemotherapy + Tarceva	No text entered.
Chemotherapy Alone	No text entered.

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Chemotherapy + Tarceva	No text entered.
Chemotherapy Alone	No text entered.

Baseline Measures

	Chemotherapy + Tarceva	Chemotherapy Alone	Total
Number of Participants [units: participants]	5	0	5
Age [units: years] Median ( Full Range )	64 ( 56 to 71 )		64 ( 56 to 71 )
Gender [units: participants]
Female	1	0	1
Male	4	0	4
Region of Enrollment [units: participants]
United States	5	0	5

Outcome Measures

1. Primary:

Number of Patients With Response [ Time Frame: 5 Years to collect outcome information ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Despite active study recruitment and screening for this study, only 5 subjects were enrolled out of the planned 40 subjects. Of the 5 subjects enrolled, only 1 patient was evaluable for response assessment. The study was subsequently terminated.

Results Point of Contact:

Name/Title: Mellanie Price, B.S.
Organization: University of Texas M.D. Anderson Cancer Center
phone: 713-792-4392
e-mail: mejprice@mdanderson.org

No publications provided

Responsible Party:	Ralph Zinner, M.D./Assistant Professor, University of Texas M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00063258 History of Changes
Other Study ID Numbers:	ID02-327
Study First Received:	June 24, 2003
Results First Received:	August 25, 2010
Last Updated:	May 5, 2011
Health Authority:	United States: Food and Drug Administration