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Carcinoma, Renal CellPhase 3ARCCNCT00065468

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

A Phase 3 study testing Interferon Alfa, CCI-779 and Interferon Alfa and CCI-779 in people with Carcinoma, Renal Cell and Kidney Neoplasms, run by Pfizer at 153 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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]… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell, Kidney Neoplasms
What is being tested?
Interferon Alfa, CCI-779 and Interferon Alfa and CCI-779
Could I receive a placebo?
No, everyone receives an active treatment
How many people
626 participants
Where
153 sitesin 26 countries
Study dates
Jul 2003to Mar 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,

Who cannot join

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

Trial locations and contacts

153 sites in 26 countries.

153 sites in 26 countries

United States48 sites

  • Pfizer Investigational Site

    Ann Arbor, Michigan, 48109-0942

  • Pfizer Investigational Site

    Baltimore, Maryland, 21231-1000

  • Pfizer Investigational Site

    Billings, Montana, 59101

  • Pfizer Investigational Site

    Boca Raton, Florida, 33428

  • Pfizer Investigational Site

    Boston, Massachusetts, 02215

  • Pfizer Investigational Site

    Charleston, South Carolina, 29414

  • Pfizer Investigational Site

    Chicago, Illinois, 60612-3824

  • Pfizer Investigational Site

    Cleveland, Ohio, 44195

  • Pfizer Investigational Site

    Detroit, Michigan, 48202

  • Pfizer Investigational Site

    Durham, North Carolina, 27710

  • Pfizer Investigational Site

    East Orange, New Jersey, 07018

  • Pfizer Investigational Site

    Great Falls, Montana, 59405

  • Pfizer Investigational Site

    Hershey, Pennsylvania, 17033-0850

  • Pfizer Investigational Site

    Hickory, North Carolina, 28602

  • Pfizer Investigational Site

    Houston, Texas, 77030

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46303

  • Pfizer Investigational Site

    Kansas City, Kansas, 66160-7136

  • Pfizer Investigational Site

    Kansas City, Missouri, 64131

  • Pfizer Investigational Site

    Knoxville, Tennessee, 37920

  • Pfizer Investigational Site

    La Verne, California, 91750

  • Pfizer Investigational Site

    Lebanon, New Hampshire, 03766

  • Pfizer Investigational Site

    Little Rock, Arkansas, 72205

  • Pfizer Investigational Site

    Los Angeles, California, 90024-2828

  • Pfizer Investigational Site

    Louisville, Kentucky, 40202

  • Pfizer Investigational Site

    Memphis, Tennessee, 38120

  • Pfizer Investigational Site

    Miami, Florida, 33136

  • Pfizer Investigational Site

    Morristown, New Jersey, 07960

  • Pfizer Investigational Site

    Nashville, Tennessee, 37232-6310

  • Pfizer Investigational Site

    New Orleans, Louisiana, 70121

  • Pfizer Investigational Site

    New York, New York, 10021

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73104

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19111

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • Pfizer Investigational Site

    Portland, Oregon, 97213-2933

  • Pfizer Investigational Site

    Richmond, Virginia, 23249

  • Pfizer Investigational Site

    Rochester, New York, 14642

  • Pfizer Investigational Site

    Salt Lake City, Utah, 84112

  • Pfizer Investigational Site

    San Diego, California, 92123

  • Pfizer Investigational Site

    San Francisco, California, 94115

  • Pfizer Investigational Site

    Seattle, Washington, 98101

  • Pfizer Investigational Site

    Seattle, Washington, 98109-1023

  • Pfizer Investigational Site

    South Bend, Indiana, 46601

  • Pfizer Investigational Site

    St Louis, Missouri, 63110

  • Pfizer Investigational Site

    Terre Haute, Indiana, 47802

  • Pfizer Investigational Site

    The Bronx, New York, 10466

  • Pfizer Investigational Site

    Urbana, Illinois, 61801

  • Pfizer Investigational Site

    Valhalla, New York, 10595

  • Pfizer Investigational Site

    Waterbury, Connecticut, 06708

Other trials in United States

Canada16 sites

  • Pfizer Investigational Site

    Edmonton, Alberta, T6G 1Z2

  • Pfizer Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • Pfizer Investigational Site

    Halifax, Nova Scotia, B3H 1V7

  • Pfizer Investigational Site

    Hamilton, Ontario, L8N 4A6

  • Pfizer Investigational Site

    Kelowna, British Columbia, V1Y 5L3

  • Pfizer Investigational Site

    London, Ontario, N6A 4L5

  • Pfizer Investigational Site

    Montreal, Quebec, H2L 4M1

  • Pfizer Investigational Site

    Montreal, Quebec, H2X 3J4

  • Pfizer Investigational Site

    Montreal, Quebec, H3T 1E2

  • Pfizer Investigational Site

    Newmarket, Ontario, L3Y 2P9

  • Pfizer Investigational Site

    Ottawa, Ontario, K1H 8L6

  • Pfizer Investigational Site

    Québec, Quebec, G1R 2J6

  • Pfizer Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • Pfizer Investigational Site

    Toronto, Ontario, M4N 3M5

  • Pfizer Investigational Site

    Vancouver, British Columbia, V5Z 3J5

  • Pfizer Investigational Site

    Winnipeg, Manitoba, R3E 0C9

Other trials in Canada

Russia13 sites

  • Pfizer Investigational Site

    Barnaul, 656052

  • Pfizer Investigational Site

    Kemerovo, 650003

  • Pfizer Investigational Site

    Moscow, 115478

  • Pfizer Investigational Site

    Moscow, 121356

  • Pfizer Investigational Site

    Moscow, 125284

  • Pfizer Investigational Site

    Moscow, 143423

  • Pfizer Investigational Site

    Obninsk, 249036

  • Pfizer Investigational Site

    Saint Petersburg, 188663

  • Pfizer Investigational Site

    Saint Petersburg, 194354

  • Pfizer Investigational Site

    Saint Petersburg, 197758

  • Pfizer Investigational Site

    Saint Petersburg

  • Pfizer Investigational Site

    Ufa, 450005

  • Pfizer Investigational Site

    Ufa

Other trials in Russia

Poland9 sites

  • Pfizer Investigational Site

    Bytom, 41-902

  • Pfizer Investigational Site

    Lodz, 93-509

  • Pfizer Investigational Site

    Lublin, 20-090

  • Pfizer Investigational Site

    Olsztyn, 10-228

  • Pfizer Investigational Site

    Opole, 45-060

  • Pfizer Investigational Site

    Poznan, 61-878

  • Pfizer Investigational Site

    Siedlce, 08-110

  • Pfizer Investigational Site

    Warsaw, 00-909

  • Pfizer Investigational Site

    Warsaw, 02-781

Other trials in Poland

Australia7 sites

  • Pfizer Investigational Site

    Adelaide, South Australia, 5000

  • Pfizer Investigational Site

    Footscray, Victoria, 3012

  • Pfizer Investigational Site

    Heidelberg, Victoria, 3084

  • Pfizer Investigational Site

    Kogarah, New South Wales, 2217

  • Pfizer Investigational Site

    Melbourne, Victoria, 3050

  • Pfizer Investigational Site

    Newcastle, New South Wales

  • Pfizer Investigational Site

    Westmead, New South Wales, 2145

Other trials in Australia

Argentina6 sites

  • Pfizer Investigational Site

    Buenos, Aires

  • Pfizer Investigational Site

    Buenos Aires, Buenos Aires, C1426ANZ

  • Pfizer Investigational Site

    Córdoba, Córdoba Province, 5000

  • Pfizer Investigational Site

    Mendoza

  • Pfizer Investigational Site

    Quilmes

  • Pfizer Investigational Site

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Ukraine6 sites

  • Pfizer Investigational Site

    Dnietropetrovsk

  • Pfizer Investigational Site

    Donetsk, 83 092

  • Pfizer Investigational Site

    Kharkiv, 61 037

  • Pfizer Investigational Site

    Kiev, 03 142

  • Pfizer Investigational Site

    Lviv, 79031

  • Pfizer Investigational Site

    Zaporizhzhya, 69103

Other trials in Ukraine

Slovakia4 sites

  • Pfizer Investigational Site

    Banská Bystrica, 974 01

  • Pfizer Investigational Site

    Bratislava, 833 10

  • Pfizer Investigational Site

    Martin, 03659

  • Pfizer Investigational Site

    Zlina, 012 07

Other trials in Slovakia

South Africa4 sites

  • Pfizer Investigational Site

    Cape Town, 7505

  • Pfizer Investigational Site

    Gauteng

  • Pfizer Investigational Site

    Johannesburg, Gauteng, 2197

  • Pfizer Investigational Site

    Port Elizabeth, Eastern Cape, 6006

Other trials in South Africa

Spain4 sites

  • Pfizer Investigational Site

    Badalona, Barcelona, 08916

  • Pfizer Investigational Site

    Barcelona, Barcelona, 08025

  • Pfizer Investigational Site

    Madrid, Madrid, 28040

  • Pfizer Investigational Site

    Oviedo, Principality of Asturias, 33006

Other trials in Spain

Taiwan4 sites

  • Pfizer Investigational Site

    Taichung

  • Pfizer Investigational Site

    Taipei, ROC, 112

  • Pfizer Investigational Site

    Taipei, 104

  • Pfizer Investigational Site

    Taoyuan, 333

Other trials in Taiwan

United Kingdom4 sites

  • Pfizer Investigational Site

    Glasgow, Strathclyde, G11 6NT

  • Pfizer Investigational Site

    Manchester, Lancashire, M20 4BX

  • Pfizer Investigational Site

    Nottingham, NG5 1PB

  • Pfizer Investigational Site

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Germany3 sites

  • Pfizer Investigational Site

    Bonn, North Rhine-Westphalia, 53105

  • Pfizer Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • Pfizer Investigational Site

    Mainz, Rhineland-Palatinate, D-55101

Other trials in Germany

Italy3 sites

  • Pfizer Investigational Site

    Foggia, 71100

  • Pfizer Investigational Site

    Milan, 20132

  • Pfizer Investigational Site

    Roma, RM, 00144

Other trials in Italy

Latvia3 sites

  • Pfizer Investigational Site

    Daugavpils

  • Pfizer Investigational Site

    Riga, 1002

  • Pfizer Investigational Site

    Riga, 1079

Other trials in Latvia

Netherlands3 sites

  • Pfizer Investigational Site

    Amsterdam, 1105 AZ

  • Pfizer Investigational Site

    Enschede, 7511 JX

  • Pfizer Investigational Site

    Nijmegen, GA, 6525

Other trials in Netherlands

Sweden3 sites

  • Pfizer Investigational Site

    Gothenburg, 41345

  • Pfizer Investigational Site

    Stockholm, Sweden, 171 76

  • Pfizer Investigational Site

    Uppsala, 751 85

Other trials in Sweden

Czechia2 sites

  • Pfizer Investigational Site

    Brno, 656 53

  • Pfizer Investigational Site

    Prague, 150 00

Other trials in Czechia

Greece2 sites

  • Pfizer Investigational Site

    Heraklion, Creete

  • Pfizer Investigational Site

    Pátrai

Other trials in Greece

Mexico2 sites

  • Pfizer Investigational Site

    León, 37000

  • Pfizer Investigational Site

    Monterrey, Nuevo León, 64000

Other trials in Mexico

Turkey (Türkiye)2 sites

  • Pfizer Investigational Site

    Istanbul

  • Pfizer Investigational Site

    Izmir, 35100

Other trials in Turkey (Türkiye)

Hungary1 site

  • Pfizer Investigational Site

    Budapest, H-1122

Other trials in Hungary

Lithuania1 site

  • Pfizer Investigational Site

    Vilnius, 2021

Other trials in Lithuania

Serbia and Montenegro1 site

  • Pfizer Investigational Site

    Sremska Kamenica, Novi Sad, 21204

Other trials in Serbia and Montenegro

Serbia1 site

  • Pfizer Investigational Site

    Belgrade, 11000

Other trials in Serbia

Location not given1 site

  • Pfizer Investigational Site

About this study

Official title: 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.

Being tested
Interferon Alfa, CCI-779, Interferon Alfa and CCI-779
Keywords
Advanced Renal Cell Carcinoma, Kidney Cancer
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interferon AlfaDrug

    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.

  • CCI-779Drug

    25 mg of CCI-779 given Intra Venously once per week

  • Interferon Alfa and CCI-779Drug

    15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week

Study groups in NCT00065468
Study groupRoleWhat they receive
AActive comparatorNot described
Receives: Drug: Interferon Alfa
BExperimentalNot described
Receives: Drug: CCI-779
CExperimentalNot described
Receives: Drug: Interferon Alfa and CCI-779

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.

    Measured: Baseline up to Month 80

Secondary outcomes (7)

  1. Progression-Free Survival (PFS)

    PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.

    Measured: Baseline, monthly until tumor progression or death (up to Month 80)

  2. Percentage of Participants With Objective Response

    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.

    Measured: Baseline, every 2 months until tumor progression or death (up to Month 80)

  3. Percentage of Participants With Clinical Benefit

    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.

    Measured: Baseline, every 2 months until tumor progression or death (up to Month 80)

  4. Duration of Response (DR)

    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.

    Measured: Baseline, every month until tumor progression or death (up to Month 80)

  5. Time to Treatment Failure (TTF)

    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.

    Measured: Baseline, every month until tumor progression or death (up to Month 80)

  6. Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)

    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.

    Measured: Baseline to Month 80

  7. European Quality of Life Health Questionnaire (EQ-5D) - Index Score

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2003 (estimated)
  2. Study startJul 2003
  3. Primary completionJun 2006
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
626 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00065468
Sponsor's protocol ID
3066K1-304
Acronym
ARCC
Status last verified
Sep 2012
First submitted
24 Jul 2003
Last updated
25 Oct 2012
Data monitoring committee
Yes

Publications

  • Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

    PubMed 37146227

  • de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

    PubMed 28410911

  • Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

    PubMed 27238653

  • Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.

    PubMed 25577718

  • 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. doi: 10.1056/NEJMoa066838.

    PubMed 17538086

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Interferon Alfa, CCI-779 and Interferon Alfa and CCI-779 in people with Carcinoma, Renal Cell and Kidney Neoplasms, run by Pfizer at 153 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in United States, Canada, Russia, Poland, Australia and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Baseline up to Month 80). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00065468, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2012.

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