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
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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

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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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.

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

Serious Adverse Events

	Interferon Alfa	Temsirolimus	Interferon Alfa and Temsirolimus
Total, serious adverse events
# participants affected / at risk	99/200 (49.50%)	82/208 (39.42%)	122/208 (58.65%)
Blood and lymphatic system disorders
ANEMIA ^{* 1 [3]}
# participants affected / at risk	12/200 (6.00%)	11/208 (5.29%)	20/208 (9.62%)
THROMBOCYTOPENIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	4/208 (1.92%)
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
DISSEMINATED INTRAVASCULAR COAGULATION ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
FIBRINOGEN INCREASED ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
THROMBIN TIME PROLONGED ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
Cardiac disorders
ATRIAL FIBRILLATION ^{* 1 [4]}
# participants affected / at risk	2/200 (1.00%)	2/208 (0.96%)	1/208 (0.48%)
CONGESTIVE HEART FAILURE ^{* 1}
# participants affected / at risk	1/200 (0.50%)	2/208 (0.96%)	0/208 (0.00%)
DEEP VEIN THROMBOSIS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	2/208 (0.96%)	0/208 (0.00%)
HYPERTENSION ^{* 1}
# participants affected / at risk	1/200 (0.50%)	2/208 (0.96%)	2/208 (0.96%)
MYOCARDIAL INFARCT ^{* 1}
# participants affected / at risk	2/200 (1.00%)	2/208 (0.96%)	1/208 (0.48%)
PULMONARY EMBOLUS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	2/208 (0.96%)	3/208 (1.44%)
CEREBROVASCULAR ACCIDENT ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	1/208 (0.48%)
HEART FAILURE ^{* 1}
# participants affected / at risk	1/200 (0.50%)	1/208 (0.48%)	2/208 (0.96%)
INTRACRANIAL HEMORRHAGE 0 ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
PERICARDIAL EFFUSION ^{* 1}
# participants affected / at risk	1/200 (0.50%)	1/208 (0.48%)	0/208 (0.00%)
PERIPHERAL GANGRENE ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
SYNCOPE ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
TACHYCARDIA SINUS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
ANGINA PECTORIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
CARDIOMYOPATHY ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
CEREBRAL HEMORRHAGE ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
CEREBRAL ISCHEMIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
CEREBROVASCULAR DISORDER ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
HEART ARREST ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
HEMORRHAGE ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	2/208 (0.96%)
HYPOTENSION ^{* 1}
# participants affected / at risk	2/200 (1.00%)	0/208 (0.00%)	2/208 (0.96%)
HYPOVOLEMIA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
POSTURAL HYPOTENSION 1 ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
SHOCK ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
THROMBOSIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
VASCULAR DISORDER ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
Endocrine disorders
DIABETES MELLITUS ^{* 1 [5]}
# participants affected / at risk	0/200 (0.00%)	2/208 (0.96%)	0/208 (0.00%)
THYROID CARCINOMA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
Eye disorders
CATARACT SPECIFIED ^{* 1 [6]}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	2/208 (0.96%)
DIPLOPIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
Gastrointestinal disorders
STOMATITIS ^{* 1 [7]}
# participants affected / at risk	0/200 (0.00%)	3/208 (1.44%)	4/208 (1.92%)
GASTROINTESTINAL HEMORRHAGE ^{* 1}
# participants affected / at risk	0/200 (0.00%)	2/208 (0.96%)	0/208 (0.00%)
NAUSEA ^{* 1}
# participants affected / at risk	3/200 (1.50%)	2/208 (0.96%)	2/208 (0.96%)
VOMITING ^{* 1}
# participants affected / at risk	3/200 (1.50%)	2/208 (0.96%)	1/208 (0.48%)
DIARRHEA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	1/208 (0.48%)	6/208 (2.88%)
GASTROINTESTINAL DISORDER ^{* 1}
# participants affected / at risk	1/200 (0.50%)	1/208 (0.48%)	0/208 (0.00%)
ILEUS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	1/208 (0.48%)
INTESTINAL PERFORATION ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
MUCOSITIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	2/208 (0.96%)
ANOREXIA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	3/208 (1.44%)
COLITIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
CONSTIPATION ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	1/208 (0.48%)
GASTROENTERITIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
HEMATEMESIS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
HEMORRHAGIC GASTRITIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
HEPATIC FAILURE ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
HEPATITIS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
INTESTINAL OBSTRUCTION ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	1/208 (0.48%)
LIVER FATTY DEPOSIT ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
MELENA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
PROCTITIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
RECTAL HEMORRHAGE ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
General disorders
ABDOMINAL PAIN ^{* 1 [8]}
# participants affected / at risk	1/200 (0.50%)	5/208 (2.40%)	4/208 (1.92%)
BACK PAIN ^{* 1}
# participants affected / at risk	2/200 (1.00%)	4/208 (1.92%)	1/208 (0.48%)
CARCINOMA ^{* 1}
# participants affected / at risk	9/200 (4.50%)	4/208 (1.92%)	13/208 (6.25%)
ASTHENIA ^{* 1}
# participants affected / at risk	7/200 (3.50%)	3/208 (1.44%)	10/208 (4.81%)
FEVER ^{* 1}
# participants affected / at risk	3/200 (1.50%)	3/208 (1.44%)	8/208 (3.85%)
ASCITES ^{* 1}
# participants affected / at risk	1/200 (0.50%)	2/208 (0.96%)	0/208 (0.00%)
GENERAL PHYSICAL HEALTH DETERIORATION ^{* 1}
# participants affected / at risk	0/200 (0.00%)	2/208 (0.96%)	1/208 (0.48%)
PAIN ^{* 1}
# participants affected / at risk	0/200 (0.00%)	2/208 (0.96%)	3/208 (1.44%)
ABSCESS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	1/208 (0.48%)	0/208 (0.00%)
ACCIDENTAL INJURY ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	3/208 (1.44%)
CHEST PAIN ^{* 1}
# participants affected / at risk	1/200 (0.50%)	1/208 (0.48%)	1/208 (0.48%)
HERNIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
INFECTION ^{* 1}
# participants affected / at risk	1/200 (0.50%)	1/208 (0.48%)	1/208 (0.48%)
INFLAMMATION ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
MALAISE ^{* 1}
# participants affected / at risk	1/200 (0.50%)	1/208 (0.48%)	0/208 (0.00%)
MEDICATION ERROR ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
NEOPLASM ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
OVERDOSE ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	2/208 (0.96%)
PELVIC PAIN ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
SEPSIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	3/208 (1.44%)
ABDOMINAL SYNDROME ACUTE ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
ACCIDENTAL OVERDOSE ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
ALLERGIC REACTION ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	1/208 (0.48%)
CELLULITIS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	3/208 (1.44%)
CHILLS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
FLU SYNDROME ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
GENERALIZED EDEMA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
NECK PAIN ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	2/208 (0.96%)
TUMOR LYSIS SYNDROME ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
DEVICE MALFUNCTION ^{* 1 [9]}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	2/208 (0.96%)
Metabolism and nutrition disorders
HYPERGLYCEMIA ^{* 1 [10]}
# participants affected / at risk	0/200 (0.00%)	6/208 (2.88%)	0/208 (0.00%)
DEHYDRATION ^{* 1}
# participants affected / at risk	7/200 (3.50%)	5/208 (2.40%)	10/208 (4.81%)
CREATININE INCREASED ^{* 1}
# participants affected / at risk	0/200 (0.00%)	3/208 (1.44%)	1/208 (0.48%)
HYPERCALCEMIA ^{* 1}
# participants affected / at risk	2/200 (1.00%)	3/208 (1.44%)	4/208 (1.92%)
HYPERKALEMIA ^{* 1}
# participants affected / at risk	2/200 (1.00%)	2/208 (0.96%)	2/208 (0.96%)
ALKALINE PHOSPHATASE INCREASED ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
BUN INCREASED ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
HYPERLIPEMIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	3/208 (1.44%)
HYPOCALCEMIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	2/208 (0.96%)
HYPOKALEMIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
HYPONATREMIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	1/208 (0.48%)
PERIPHERAL EDEMA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	1/208 (0.48%)	1/208 (0.48%)
SGOT INCREASED ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
BILIRUBINEMIA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
CACHEXIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	2/208 (0.96%)
FAILURE TO THRIVE ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	1/208 (0.48%)
HYPOGLYCEMIAHYPOGLYCEMIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
HYPOPROTEINEMIA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
KETOSIS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
WEIGHT LOSS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	1/208 (0.48%)
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE ^{* 1 [11]}
# participants affected / at risk	0/200 (0.00%)	2/208 (0.96%)	1/208 (0.48%)
BONE PAIN ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	1/208 (0.48%)
MYALGIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
SPINAL FRACTURE ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
ARTHRALGIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
BONE DISORDER ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
OSTEOPOROSIS FRACTURE ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
Nervous system disorders
CONFUSION ^{* 1 [12]}
# participants affected / at risk	3/200 (1.50%)	3/208 (1.44%)	0/208 (0.00%)
DIZZINESS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	1/208 (0.48%)
HYPOTONIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
PARESIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	1/208 (0.48%)
SPINAL CORD COMPRESSION ^{* 1}
# participants affected / at risk	1/200 (0.50%)	1/208 (0.48%)	0/208 (0.00%)
AGITATION ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
AMNESIA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
APHASIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
CNS DEPRESSION ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
CNS NEOPLASIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
COMA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
CONVULSION ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	1/208 (0.48%)
DELIRIUM ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
DEPRESSION ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
DYSTONIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
EXTRAPYRAMIDAL SYNDROME ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
GRAND MAL CONVULSION ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
HYPESTHESIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
INSOMNIA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
MENTAL STATUS CHANGES ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
NEUROPATHY ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
PARALYSIS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
PARKINSON'S DISEASE ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
PSYCHOSIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
SOMNOLENCE ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	1/208 (0.48%)
SUICIDAL IDEATION ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
Renal and urinary disorders
ACUTE KIDNEY FAILURE ^{* 1 [13]}
# participants affected / at risk	6/200 (3.00%)	3/208 (1.44%)	4/208 (1.92%)
GLOMERULITIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
KIDNEY FAILURE ^{* 1}
# participants affected / at risk	1/200 (0.50%)	1/208 (0.48%)	3/208 (1.44%)
UREMIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
URINARY TRACT INFECTION ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
HEMATURIA ^{* 1}
# participants affected / at risk	3/200 (1.50%)	0/208 (0.00%)	0/208 (0.00%)
KIDNEY FUNCTION ABNORMAL ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	3/208 (1.44%)
OLIGURIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
URINARY INCONTINENCE ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	2/208 (0.96%)
URINARY RETENTION ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
URINARY TRACT DISORDER ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ^{* 1 [14]}
# participants affected / at risk	3/200 (1.50%)	10/208 (4.81%)	11/208 (5.29%)
PLEURAL EFFUSION ^{* 1}
# participants affected / at risk	4/200 (2.00%)	6/208 (2.88%)	4/208 (1.92%)
DYSPNEA ^{* 1}
# participants affected / at risk	9/200 (4.50%)	2/208 (0.96%)	15/208 (7.21%)
PNEUMONITIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	2/208 (0.96%)	0/208 (0.00%)
RESPIRATORY FAILURE ^{* 1}
# participants affected / at risk	3/200 (1.50%)	2/208 (0.96%)	3/208 (1.44%)
ASTHMA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	1/208 (0.48%)
BRONCHITIS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	1/208 (0.48%)	2/208 (0.96%)
CARCINOMA OF LUNG ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
HEMOTHORAX ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
PHARYNGITIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	1/208 (0.48%)
PNEUMOTHORAX ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/208 (0.48%)	0/208 (0.00%)
ASPIRATION ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
BRONCHIOLITIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
COUGH INCREASED ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
EPISTAXIS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
HEMOPTYSIS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
HYPOXIA ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
LUNG EDEMA ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
LUNG FIBROSIS ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	0/208 (0.00%)
LUNG INFILTRATION NOS ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
RESPIRATORY DISORDER ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)
RESPIRATORY DISTRESS SYNDROME ^{* 1}
# participants affected / at risk	1/200 (0.50%)	0/208 (0.00%)	1/208 (0.48%)
Skin and subcutaneous tissue disorders
SKIN CARCINOMA ^{* 1 [15]}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	2/208 (0.96%)
SKIN ULCER ^{* 1}
# participants affected / at risk	0/200 (0.00%)	0/208 (0.00%)	1/208 (0.48%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, COSTART
[3]	Hemic and Lymphatic system
[4]	Cardiovascular system
[5]	Endocrine system
[6]	Special senses
[7]	Digestive System
[8]	Body as a whole
[9]	Adverse event associated with miscellaneous factors
[10]	Metabolic and Nutritional
[11]	Musculoskeletal system
[12]	Nervous system
[13]	Urogenital system
[14]	Respiratory system
[15]	Skin and Appendages

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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