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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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	The same event may appear as both an AE and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.

Frequency Threshold

Threshold above which other adverse events are reported	5%

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

Other Adverse Events

	Interferon Alfa	Temsirolimus	Interferon Alfa and Temsirolimus
Total, other (not including serious) adverse events
# participants affected / at risk	197/200	208/208	205/208
Blood and lymphatic system disorders
ANEMIA ^{* 1 [3]}
# participants affected / at risk	78/200 (39.00%)	90/208 (43.27%)	123/208 (59.13%)
THROMBOCYTOPENIA ^{* 1}
# participants affected / at risk	16/200 (8.00%)	28/208 (13.46%)	77/208 (37.02%)
NEUTROPENIA ^{* 1}
# participants affected / at risk	26/200 (13.00%)	15/208 (7.21%)	57/208 (27.40%)
LEUKOPENIA ^{* 1}
# participants affected / at risk	34/200 (17.00%)	13/208 (6.25%)	65/208 (31.25%)
LYMPHOPENIA ^{* 1}
# participants affected / at risk	17/200 (8.50%)	11/208 (5.29%)	28/208 (13.46%)
Cardiac disorders
HYPERTENSION ^{* 1 [4]}
# participants affected / at risk	7/200 (3.50%)	12/208 (5.77%)	12/208 (5.77%)
HYPOTENSION ^{* 1}
# participants affected / at risk	11/200 (5.50%)	10/208 (4.81%)	7/208 (3.37%)
TACHYCARDIA ^{* 1}
# participants affected / at risk	11/200 (5.50%)	9/208 (4.33%)	17/208 (8.17%)
VASODILATATION ^{* 1}
# participants affected / at risk	5/200 (2.50%)	5/208 (2.40%)	12/208 (5.77%)
Gastrointestinal disorders
NAUSEA ^{* 1 [5]}
# participants affected / at risk	82/200 (41.00%)	76/208 (36.54%)	84/208 (40.38%)
ANOREXIA ^{* 1}
# participants affected / at risk	86/200 (43.00%)	66/208 (31.73%)	79/208 (37.98%)
DIARRHEA ^{* 1}
# participants affected / at risk	39/200 (19.50%)	57/208 (27.40%)	56/208 (26.92%)
CONSTIPATION ^{* 1}
# participants affected / at risk	35/200 (17.50%)	42/208 (20.19%)	39/208 (18.75%)
STOMATITIS ^{* 1}
# participants affected / at risk	7/200 (3.50%)	41/208 (19.71%)	42/208 (20.19%)
MUCOSITIS ^{* 1}
# participants affected / at risk	10/200 (5.00%)	39/208 (18.75%)	46/208 (22.12%)
VOMITING ^{* 1}
# participants affected / at risk	57/200 (28.50%)	39/208 (18.75%)	60/208 (28.85%)
DRY MOUTH ^{* 1}
# participants affected / at risk	16/200 (8.00%)	13/208 (6.25%)	12/208 (5.77%)
MOUTH ULCERATION ^{* 1}
# participants affected / at risk	5/200 (2.50%)	6/208 (2.88%)	15/208 (7.21%)
ORAL MONILIASIS ^{* 1}
# participants affected / at risk	4/200 (2.00%)	5/208 (2.40%)	15/208 (7.21%)
General disorders
ASTHENIA ^{* 1 [6]}
# participants affected / at risk	126/200 (63.00%)	105/208 (50.48%)	127/208 (61.06%)
PAIN ^{* 1}
# participants affected / at risk	30/200 (15.00%)	56/208 (26.92%)	41/208 (19.71%)
FEVER ^{* 1}
# participants affected / at risk	98/200 (49.00%)	49/208 (23.56%)	126/208 (60.58%)
ABDOMINAL PAIN ^{* 1}
# participants affected / at risk	34/200 (17.00%)	42/208 (20.19%)	34/208 (16.35%)
BACK PAIN ^{* 1}
# participants affected / at risk	28/200 (14.00%)	41/208 (19.71%)	31/208 (14.90%)
CHEST PAIN ^{* 1}
# participants affected / at risk	18/200 (9.00%)	35/208 (16.83%)	23/208 (11.06%)
HEADACHE ^{* 1}
# participants affected / at risk	30/200 (15.00%)	32/208 (15.38%)	47/208 (22.60%)
INFECTION ^{* 1}
# participants affected / at risk	11/200 (5.50%)	29/208 (13.94%)	32/208 (15.38%)
ALLERGIC REACTION ^{* 1}
# participants affected / at risk	1/200 (0.50%)	18/208 (8.65%)	11/208 (5.29%)
CHILLS ^{* 1}
# participants affected / at risk	58/200 (29.00%)	17/208 (8.17%)	72/208 (34.62%)
FACE EDEMA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	15/208 (7.21%)	10/208 (4.81%)
ACCIDENTAL INJURY ^{* 1}
# participants affected / at risk	8/200 (4.00%)	13/208 (6.25%)	12/208 (5.77%)
FLU SYNDROME ^{* 1}
# participants affected / at risk	23/200 (11.50%)	8/208 (3.85%)	28/208 (13.46%)
LAB TEST ABNORMAL ^{* 1}
# participants affected / at risk	5/200 (2.50%)	8/208 (3.85%)	13/208 (6.25%)
TASTE PERVERSION ^{* 1 [7]}
# participants affected / at risk	13/200 (6.50%)	31/208 (14.90%)	18/208 (8.65%)
TASTE LOSS ^{* 1 [7]}
# participants affected / at risk	4/200 (2.00%)	11/208 (5.29%)	5/208 (2.40%)
Metabolism and nutrition disorders
HYPERLIPEMIA ^{* 1 [8]}
# participants affected / at risk	29/200 (14.50%)	57/208 (27.40%)	80/208 (38.46%)
PERIPHERAL EDEMA ^{* 1}
# participants affected / at risk	15/200 (7.50%)	54/208 (25.96%)	36/208 (17.31%)
HYPERCHOLESTEREMIA ^{* 1}
# participants affected / at risk	9/200 (4.50%)	51/208 (24.52%)	55/208 (26.44%)
HYPERGLYCEMIA ^{* 1}
# participants affected / at risk	22/200 (11.00%)	49/208 (23.56%)	36/208 (17.31%)
WEIGHT LOSS ^{* 1}
# participants affected / at risk	49/200 (24.50%)	40/208 (19.23%)	65/208 (31.25%)
CREATININE INCREASED ^{* 1}
# participants affected / at risk	21/200 (10.50%)	28/208 (13.46%)	42/208 (20.19%)
ALKALINE PHOSPHATASE INCREASED ^{* 1}
# participants affected / at risk	15/200 (7.50%)	20/208 (9.62%)	31/208 (14.90%)
HYPOKALEMIA ^{* 1}
# participants affected / at risk	7/200 (3.50%)	20/208 (9.62%)	14/208 (6.73%)
EDEMA ^{* 1}
# participants affected / at risk	8/200 (4.00%)	19/208 (9.13%)	8/208 (3.85%)
HYPOPHOSPHATEMIA ^{* 1}
# participants affected / at risk	4/200 (2.00%)	17/208 (8.17%)	21/208 (10.10%)
SGOT INCREASED ^{* 1}
# participants affected / at risk	29/200 (14.50%)	16/208 (7.69%)	43/208 (20.67%)
HYPOPROTEINEMIA ^{* 1}
# participants affected / at risk	18/200 (9.00%)	13/208 (6.25%)	21/208 (10.10%)
LACTIC DEHYDROGENASE INCREASED ^{* 1}
# participants affected / at risk	7/200 (3.50%)	12/208 (5.77%)	19/208 (9.13%)
SGPT INCREASED ^{* 1}
# participants affected / at risk	14/200 (7.00%)	12/208 (5.77%)	15/208 (7.21%)
HYPOCALCEMIA ^{* 1}
# participants affected / at risk	21/200 (10.50%)	11/208 (5.29%)	32/208 (15.38%)
HYPERCALCEMIA ^{* 1}
# participants affected / at risk	11/200 (5.50%)	8/208 (3.85%)	8/208 (3.85%)
HYPERKALEMIA ^{* 1}
# participants affected / at risk	18/200 (9.00%)	8/208 (3.85%)	11/208 (5.29%)
DEHYDRATION ^{* 1}
# participants affected / at risk	15/200 (7.50%)	7/208 (3.37%)	22/208 (10.58%)
HYPONATREMIA ^{* 1}
# participants affected / at risk	7/200 (3.50%)	6/208 (2.88%)	15/208 (7.21%)
BUN INCREASED ^{* 1}
# participants affected / at risk	5/200 (2.50%)	3/208 (1.44%)	11/208 (5.29%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^{* 1 [9]}
# participants affected / at risk	29/200 (14.50%)	38/208 (18.27%)	27/208 (12.98%)
MYALGIA ^{* 1}
# participants affected / at risk	30/200 (15.00%)	16/208 (7.69%)	22/208 (10.58%)
BONE PAIN ^{* 1}
# participants affected / at risk	11/200 (5.50%)	8/208 (3.85%)	7/208 (3.37%)
Nervous system disorders
INSOMNIA ^{* 1 [10]}
# participants affected / at risk	29/200 (14.50%)	25/208 (12.02%)	36/208 (17.31%)
DIZZINESS ^{* 1}
# participants affected / at risk	25/200 (12.50%)	18/208 (8.65%)	27/208 (12.98%)
ANXIETY ^{* 1}
# participants affected / at risk	12/200 (6.00%)	16/208 (7.69%)	24/208 (11.54%)
PARESTHESIA ^{* 1}
# participants affected / at risk	10/200 (5.00%)	14/208 (6.73%)	13/208 (6.25%)
SOMNOLENCE ^{* 1}
# participants affected / at risk	21/200 (10.50%)	14/208 (6.73%)	14/208 (6.73%)
DEPRESSION ^{* 1}
# participants affected / at risk	26/200 (13.00%)	9/208 (4.33%)	25/208 (12.02%)
CONFUSION ^{* 1}
# participants affected / at risk	17/200 (8.50%)	6/208 (2.88%)	10/208 (4.81%)
Renal and urinary disorders
URINARY TRACT INFECTION ^{* 1 [11]}
# participants affected / at risk	10/200 (5.00%)	16/208 (7.69%)	23/208 (11.06%)
Respiratory, thoracic and mediastinal disorders
DYSPNEA ^{* 1 [12]}
# participants affected / at risk	42/200 (21.00%)	59/208 (28.37%)	51/208 (24.52%)
COUGH INCREASED ^{* 1}
# participants affected / at risk	29/200 (14.50%)	55/208 (26.44%)	49/208 (23.56%)
EPISTAXIS ^{* 1}
# participants affected / at risk	7/200 (3.50%)	27/208 (12.98%)	27/208 (12.98%)
PHARYNGITIS ^{* 1}
# participants affected / at risk	3/200 (1.50%)	24/208 (11.54%)	27/208 (12.98%)
RHINITIS ^{* 1}
# participants affected / at risk	4/200 (2.00%)	20/208 (9.62%)	10/208 (4.81%)
UPPER RESPIRATORY INFECTION ^{* 1}
# participants affected / at risk	1/200 (0.50%)	14/208 (6.73%)	7/208 (3.37%)
Skin and subcutaneous tissue disorders
RASH ^{* 1 [13]}
# participants affected / at risk	11/200 (5.50%)	76/208 (36.54%)	34/208 (16.35%)
PRURITUS ^{* 1}
# participants affected / at risk	16/200 (8.00%)	40/208 (19.23%)	24/208 (11.54%)
NAIL DISORDER ^{* 1}
# participants affected / at risk	1/200 (0.50%)	28/208 (13.46%)	5/208 (2.40%)
DRY SKIN ^{* 1}
# participants affected / at risk	14/200 (7.00%)	22/208 (10.58%)	13/208 (6.25%)
ACNE ^{* 1}
# participants affected / at risk	2/200 (1.00%)	21/208 (10.10%)	7/208 (3.37%)
EXFOLIATIVE DERMATITIS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	16/208 (7.69%)	6/208 (2.88%)
PRURITIC RASH ^{* 1}
# participants affected / at risk	1/200 (0.50%)	11/208 (5.29%)	3/208 (1.44%)
SKIN DISORDER ^{* 1}
# participants affected / at risk	1/200 (0.50%)	11/208 (5.29%)	6/208 (2.88%)
SWEATING ^{* 1}
# participants affected / at risk	14/200 (7.00%)	5/208 (2.40%)	15/208 (7.21%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, COSTART
[3]	Hemic and Lymphatic system
[4]	Cardiovascular system
[5]	Digestive system
[6]	Body as a whole
[7]	Special Senses
[8]	Metabolic and Nutritional
[9]	Musculoskeletal system
[10]	Nervous system
[11]	Urogenital system
[12]	Respiratory system
[13]	Skin and Appendages

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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