Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma (ARCC)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00065468

First received: July 24, 2003

Last updated: September 24, 2012

Last verified: September 2012

History of Changes

Results First Received: March 22, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Carcinoma, Renal Cell Kidney Neoplasms
Interventions:	Drug: Interferon Alfa Drug: CCI-779 Drug: Interferon Alfa and CCI-779

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
No text entered.

Reporting Groups

	Description
Interferon Alfa	Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
Temsirolimus	Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
Interferon Alfa and Temsirolimus	Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal

Participant Flow: Overall Study

	Interferon Alfa	Temsirolimus	Interferon Alfa and Temsirolimus
STARTED	207	209	210
Received Treatment	200	208	208
COMPLETED	0	0	0
NOT COMPLETED	207	209	210
Death	172	169	171
Withdrawal by Subject	3	4	5
Lost to Follow-up	5	3	2
Discontinuation of study by Sponsor	13	9	13
Disease progression	0	0	1
Unspecified	14	24	18

Baseline Characteristics

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Reporting Groups

	Description
Interferon Alfa	Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
Temsirolimus	Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
Interferon Alfa and Temsirolimus	Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
Total	Total of all reporting groups

Baseline Measures

	Interferon Alfa	Temsirolimus	Interferon Alfa and Temsirolimus	Total
Number of Participants [units: participants]	207	209	210	626
Age [units: years] Mean ± Standard Deviation	59.2 ± 10.4	58.7 ± 10.0	59.3 ± 9.8	59.1 ± 10.1
Gender [units: participants]
Female	59	70	65	194
Male	148	139	145	432

Outcome Measures

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1. Primary:

Overall Survival (OS) [ Time Frame: Baseline up to Month 80 ]

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2. Secondary:

Progression-Free Survival (PFS) [ Time Frame: Baseline, monthly until tumor progression or death (up to Month 80) ]

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3. Secondary:

Percentage of Participants With Objective Response [ Time Frame: Baseline, every 2 months until tumor progression or death (up to Month 80) ]

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4. Secondary:

Percentage of Participants With Clinical Benefit [ Time Frame: Baseline, every 2 months until tumor progression or death (up to Month 80) ]

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5. Secondary:

Duration of Response (DR) [ Time Frame: Baseline, every month until tumor progression or death (up to Month 80) ]

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6. Secondary:

Time to Treatment Failure (TTF) [ Time Frame: Baseline, every month until tumor progression or death (up to Month 80) ]

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7. Secondary:

Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) [ Time Frame: Baseline to Month 80 ]

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8. Secondary:

European Quality of Life Health Questionnaire (EQ-5D) - Index Score [ Time Frame: Baseline ]

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Measure Type	Secondary
Measure Title	European Quality of Life Health Questionnaire (EQ-5D) - Index Score
Measure Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state.
Time Frame	Baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT;(N)=participants with evaluable data. Week 12 and 32 data collected for individual participants but not summarized.

Reporting Groups

	Description
Interferon Alfa	Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
Temsirolimus	Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
Interferon Alfa and Temsirolimus	Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal

Measured Values

	Interferon Alfa	Temsirolimus	Interferon Alfa and Temsirolimus
Number of Participants Analyzed [units: participants]	197	204	197
European Quality of Life Health Questionnaire (EQ-5D) - Index Score [units: units on a scale] Median ( Full Range )	0.656 ( -0.319 to 1.000 )	0.689 ( -0.181 to 1.000 )	0.689 ( -0.239 to 1.000 )

No statistical analysis provided for European Quality of Life Health Questionnaire (EQ-5D) - Index Score

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: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
Efficacy data was not collected or analyzed after the primary analysis was completed.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided by Pfizer

Publications automatically indexed to this study:

Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I, Kovacevic Z, Lesovoy V, Schmidt-Wolf IG, Barbarash O, Gokmen E, O'Toole T, Lustgarten S, Moore L, Motzer RJ; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007 May 31;356(22):2271-81.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00065468 History of Changes
Obsolete Identifiers:	NCT00070330
Other Study ID Numbers:	3066K1-304
Study First Received:	July 24, 2003
Results First Received:	March 22, 2012
Last Updated:	September 24, 2012
Health Authority:	United States: Food and Drug Administration

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