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

September 24, 2012 updated by: Pfizer

A Phase 3, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma.

The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 [Temsirolimus], administered intravenously [IV] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa [IFN alfa] subcutaneously [SC] three times per week [TIW], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.

Study Overview

Study Type

Interventional

Enrollment (Actual)

626

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1426ANZ
        • Pfizer Investigational Site
      • Cordoba, Argentina, 5000
        • Pfizer Investigational Site
      • Mendoza, Argentina
        • Pfizer Investigational Site
      • Quilmes, Argentina
        • Pfizer Investigational Site
    • Aires
      • Buenos, Aires, Argentina
        • Pfizer Investigational Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Pfizer Investigational Site
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Pfizer Investigational Site
      • Newcastle, New South Wales, Australia
        • Pfizer Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Pfizer Investigational Site
    • Victoria
      • Footscray, Victoria, Australia, 3012
        • Pfizer Investigational Site
      • Heidelberg, Victoria, Australia, 3084
        • Pfizer Investigational Site
      • Melbourne, Victoria, Australia, 3050
        • Pfizer Investigational Site
      • Hamilton, Ontario, Canada, L8N 4A6
        • Pfizer Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Pfizer Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Pfizer Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 3J5
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0C9
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 4L5
        • Pfizer Investigational Site
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Pfizer Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3T 1E2
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2X 3J4
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Pfizer Investigational Site
      • Quebec City, Quebec, Canada, G1R 2J6
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Pfizer Investigational Site
      • Brno, Czech Republic, 656 53
        • Pfizer Investigational Site
      • Prague 5, Czech Republic, 150 00
        • Pfizer Investigational Site
    • Novi Sad
      • Sremska Kamenica, Novi Sad, Former Serbia and Montenegro, 21204
        • Pfizer Investigational Site
    • NRW
      • Bonn, NRW, Germany, 53105
        • Pfizer Investigational Site
      • Essen, NRW, Germany, 45122
        • Pfizer Investigational Site
    • RP
      • Mainz, RP, Germany, D-55101
        • Pfizer Investigational Site
      • Patra, Greece
        • Pfizer Investigational Site
    • Creete
      • Heraklion, Creete, Greece
        • Pfizer Investigational Site
      • Budapest, Hungary, H-1122
        • Pfizer Investigational Site
      • Foggia, Italy, 71100
        • Pfizer Investigational Site
      • Milano, Italy, 20132
        • Pfizer Investigational Site
    • RM
      • Roma, RM, Italy, 00144
        • Pfizer Investigational Site
      • Daugavpils, Latvia
        • Pfizer Investigational Site
      • Riga, Latvia, 1079
        • Pfizer Investigational Site
      • Riga, Latvia, 1002
        • Pfizer Investigational Site
      • Vilnius, Lithuania, 2021
        • Pfizer Investigational Site
      • Leon Guanajuato, Mexico, 37000
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64000
        • Pfizer Investigational Site
      • Amsterdam, Netherlands, 1105 AZ
        • Pfizer Investigational Site
      • Enschede, Netherlands, 7511 JX
        • Pfizer Investigational Site
    • GA
      • Nijmegen, GA, Netherlands, 6525
        • Pfizer Investigational Site
      • Bytom, Poland, 41-902
        • Pfizer Investigational Site
      • Lodz, Poland, 93-509
        • Pfizer Investigational Site
      • Lublin, Poland, 20-090
        • Pfizer Investigational Site
      • Olsztyn, Poland, 10-228
        • Pfizer Investigational Site
      • Opole, Poland, 45-060
        • Pfizer Investigational Site
      • Poznan, Poland, 61-878
        • Pfizer Investigational Site
      • Siedlce, Poland, 08-110
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-781
        • Pfizer Investigational Site
      • Warszawa, Poland, 00-909
        • Pfizer Investigational Site
      • Barnaul, Russian Federation, 656052
        • Pfizer Investigational Site
      • Kemerovo, Russian Federation, 650003
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 115478
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 143423
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 125284
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 121356
        • Pfizer Investigational Site
      • Obninsk, Russian Federation, 249036
        • Pfizer Investigational Site
      • Saint Petersburg, Russian Federation, 188663
        • Pfizer Investigational Site
      • Saint Petersburg, Russian Federation, 194354
        • Pfizer Investigational Site
      • Saint Petersburg, Russian Federation, 197758
        • Pfizer Investigational Site
      • Saint Petersburg, Russian Federation
        • Pfizer Investigational Site
      • St Petersburg, Russian Federation, 197758
        • Pfizer Investigational Site
      • Ufa, Russian Federation, 450005
        • Pfizer Investigational Site
      • Ufa, Russian Federation
        • Pfizer Investigational Site
      • Belgrade, Serbia, 11000
        • Pfizer Investigational Site
      • Banska Bystrica, Slovakia, 974 01
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 833 10
        • Pfizer Investigational Site
      • Martin, Slovakia, 03659
        • Pfizer Investigational Site
      • Zlina, Slovakia, 012 07
        • Pfizer Investigational Site
      • Cape Town, South Africa, 7505
        • Pfizer Investigational Site
      • Gauteng, South Africa
        • Pfizer Investigational Site
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6006
        • Pfizer Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2197
        • Pfizer Investigational Site
      • Barcelona, Spain, 08025
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Pfizer Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Pfizer Investigational Site
      • Göteborg, Sweden, 41345
        • Pfizer Investigational Site
      • Stockholm, Sweden, 171 76
        • Pfizer Investigational Site
      • Uppsala, Sweden, 751 85
        • Pfizer Investigational Site
      • Taichung, Taiwan
        • Pfizer Investigational Site
      • Taipei, Taiwan, 104
        • Pfizer Investigational Site
      • Taoyuan, Taiwan, 333
        • Pfizer Investigational Site
    • ROC
      • Taipei, ROC, Taiwan, 112
        • Pfizer Investigational Site
      • Istanbul, Turkey
        • Pfizer Investigational Site
      • Izmir, Turkey, 35100
        • Pfizer Investigational Site
      • Dnietropetrovsk, Ukraine
        • Pfizer Investigational Site
      • Donetsk, Ukraine, 83 092
        • Pfizer Investigational Site
      • Kharkov, Ukraine, 61 037
        • Pfizer Investigational Site
      • Kiev, Ukraine, 03 142
        • Pfizer Investigational Site
      • Lviv, Ukraine, 79031
        • Pfizer Investigational Site
      • Zaporozhye, Ukraine, 69103
        • Pfizer Investigational Site
      • Nottingham, United Kingdom, NG5 1PB
        • Pfizer Investigational Site
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M20 4BX
        • Pfizer Investigational Site
    • Strathclyde
      • Glasgow, Strathclyde, United Kingdom, G11 6NT
        • Pfizer Investigational Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • La Verne, California, United States, 91750
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90024-2828
        • Pfizer Investigational Site
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612-3824
        • Pfizer Investigational Site
      • Urbana, Illinois, United States, 61801
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46303
        • Pfizer Investigational Site
      • South Bend, Indiana, United States, 46601
        • Pfizer Investigational Site
      • Terre Haute, Indiana, United States, 47802
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160-7136
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21231-1000
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0942
        • Pfizer Investigational Site
      • Detroit, Michigan, United States, 48202
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Pfizer Investigational Site
      • Great Falls, Montana, United States, 59405
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Pfizer Investigational Site
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • Pfizer Investigational Site
      • Morristown, New Jersey, United States, 07960
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, United States, 10466
        • Pfizer Investigational Site
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14642
        • Pfizer Investigational Site
      • Valhalla, New York, United States, 10595
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Pfizer Investigational Site
      • Hickory, North Carolina, United States, 28602
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97213-2933
        • Pfizer Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19111
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37232-6310
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98101
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have not received prior systemic therapy for their disease,

Exclusion Criteria:

  • Subjects with central nervous system (CNS) metastases
  • Prior anticancer therapy for RCC
  • Prior investigational therapy/agents within 4 weeks of randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Interferon alfa (Roferon) 3 MU given Sub Cutaneously three time /week for the first week, 9 MU given Sub Cutaneously three time /week for the second week, 18 MU given Sub Cutaneously three time /week thereafter.
Experimental: B
25 mg of CCI-779 given Intra Venously once per week
Experimental: C
15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Baseline up to Month 80
Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.
Baseline up to Month 80

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Baseline, monthly until tumor progression or death (up to Month 80)
PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.
Baseline, monthly until tumor progression or death (up to Month 80)
Percentage of Participants With Objective Response
Time Frame: Baseline, every 2 months until tumor progression or death (up to Month 80)
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Baseline, every 2 months until tumor progression or death (up to Month 80)
Percentage of Participants With Clinical Benefit
Time Frame: Baseline, every 2 months until tumor progression or death (up to Month 80)
Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Baseline, every 2 months until tumor progression or death (up to Month 80)
Duration of Response (DR)
Time Frame: Baseline, every month until tumor progression or death (up to Month 80)
DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization.
Baseline, every month until tumor progression or death (up to Month 80)
Time to Treatment Failure (TTF)
Time Frame: Baseline, every month until tumor progression or death (up to Month 80)
TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase.
Baseline, every month until tumor progression or death (up to Month 80)
Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)
Time Frame: Baseline to Month 80
The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the "dispersion" of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed.
Baseline to Month 80
European Quality of Life Health Questionnaire (EQ-5D) - Index Score
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

July 24, 2003

First Submitted That Met QC Criteria

July 24, 2003

First Posted (Estimate)

July 25, 2003

Study Record Updates

Last Update Posted (Estimate)

October 25, 2012

Last Update Submitted That Met QC Criteria

September 24, 2012

Last Verified

September 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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