Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small Cell Lung Cancer Patients (Study P05146AM4)

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00632203

First received: February 29, 2008

Last updated: February 23, 2012

Last verified: February 2012

History of Changes

Results First Received: December 22, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Carcinoma, Non-Small-Cell Lung Adenocarcinoma Carcinoma, Large Cell Carcinoma, Squamous Cell
Intervention:	Drug: Temozolomide

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
Temozolomide Treatment	Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
Observation	Observation

Participant Flow: Overall Study

	Temozolomide Treatment	Observation
STARTED	26	27
COMPLETED	25	27
NOT COMPLETED	1	0
Did not start study treatment	1	0

Baseline Characteristics

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Reporting Groups

	Description
Temozolomide Treatment	Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
Observation	Observation
Total	Total of all reporting groups

Baseline Measures

	Temozolomide Treatment	Observation	Total
Number of Participants [units: participants]	26	27	53
Age [units: years] Mean ± Standard Deviation	64.8 ± 9.4	65.1 ± 10.8	65.0 ± 10.0
Gender [units: participants]
Female	12	11	23
Male	14	16	30

Outcome Measures

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1. Primary:

Number of Participants Who Had Brain Metastases [ Time Frame: Up to 12 months (as measured from day 1 of cycle 1 of standard first-line systemic chemotherapy) ]

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2. Secondary:

Time to Radiological Central Nervous System (CNS) Progression [ Time Frame: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to radiological progression or the last known CNS progression-free date ]

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3. Secondary:

Time to Progression [ Time Frame: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to progression or up to 6 cycles (168 days) of study treatment ]

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4. Secondary:

Overall Survival [ Time Frame: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up ]

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5. Secondary:

Number of Participants With Brain Metastases at First Progression [ Time Frame: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment) ]

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6. Secondary:

Cancer-related Quality of Life (QoL) as Assessed by The European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire C30 Version 3.0 (QLQ-C30), and the EORTC Lung Cancer Module (QLQ-LC13) [ Time Frame: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment) ]

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7. Secondary:

Tolerability of Maintenance Temozolomide [ Time Frame: from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment) ]

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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 principal investigator (PI) agrees not to publish/publicly present any interim results of the study without prior written consent from the Sponsor. The PI further agrees to provide 45 days written notice to the Sponsor prior to submission, to permit the Sponsor to review copies of abstracts/manuscripts for publication, which report any results of the study. The Sponsor shall have the right to review and comment on any presentation.

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
The interpretation of the study results should be taken with caution because of the small sample size due to early termination.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00632203 History of Changes
Other Study ID Numbers:	P05146
Study First Received:	February 29, 2008
Results First Received:	December 22, 2011
Last Updated:	February 23, 2012
Health Authority:	United States: Food and Drug Administration

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