Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

This study has been completed.

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by (Responsible Party):

Sarah Cannon Research Institute

ClinicalTrials.gov Identifier:

NCT00193453

First received: September 12, 2005

Last updated: October 11, 2012

Last verified: October 2012

History of Changes

Results First Received: October 11, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Lung Cancer
Interventions:	Drug: Gemcitabine Drug: Docetaxel Drug: Cetuximab

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Intervention	Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).

Participant Flow: Overall Study

	Intervention
STARTED	69
COMPLETED	21
NOT COMPLETED	48

Baseline Characteristics

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Reporting Groups

	Description
Intervention	Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).

Baseline Measures

	Intervention
Number of Participants [units: participants]	69
Age [units: participants]
<=18 years	0
Between 18 and 65 years	18
>=65 years	51
Age [units: years] Mean ± Standard Deviation	68 ± 8.7
Gender [units: participants]
Female	21
Male	48
Region of Enrollment [units: participants]
United States	69

Outcome Measures

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1. Primary:

Overall Clinical Response Rate [ Time Frame: 18 months ]

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2. Secondary:

Progression Free Survival (PFS) [ Time Frame: 18 months ]

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3. Secondary:

Response Duration [ Time Frame: 18 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.

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
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Results Point of Contact:

Name/Title: John Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: askSarah@scresearch.net

Publications of Results:

Spigel DR, Greco FA, Thompson DS, Webb C, Rubinsak J, Inhorn RC, Reeves J Jr, Vazquez ER, Lane CM, Burris HA 3rd, Hainsworth JD. Phase II study of cetuximab, docetaxel, and gemcitabine in patients with previously untreated advanced non-small-cell lung cancer. Clin Lung Cancer. 2010 May;11(3):198-203.

Responsible Party:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193453 History of Changes
Other Study ID Numbers:	SCRI LUN 92
Study First Received:	September 12, 2005
Results First Received:	October 11, 2012
Last Updated:	October 11, 2012
Health Authority:	United States: Food and Drug Administration

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