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

NCT00065468 | Completed Phase 3 Results DMC

• 1 other identifier: 3066K1-304
• Study Type: interventional
• Target: 626
• Locations: 23 countries
• Sites: 148

Brief 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 \[IFN alfa\] 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.

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Keywords

Advanced Renal Cell Carcinoma; Kidney Cancer

Outcome Measures

Primary Outcomes (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.

  Baseline up to Month 80

Secondary Outcomes (7)

• Progression-Free Survival (PFS)

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

• Percentage of Participants With Objective Response

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

• Percentage of Participants With Clinical Benefit

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

• Duration of Response (DR)

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

• Time to Treatment Failure (TTF)

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

Study Arms (3)

A

ACTIVE COMPARATOR

Drug: Interferon Alfa

B

EXPERIMENTAL

Drug: CCI-779

C

EXPERIMENTAL

Drug: Interferon Alfa and CCI-779

Interventions

Interferon Alfa DRUG

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.

A

CCI-779 DRUG

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

B

Interferon Alfa and CCI-779 DRUG

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

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (153)

Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

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La Verne, California, 91750, United States

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Los Angeles, California, 90024-2828, United States

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San Diego, California, 92123, United States

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San Francisco, California, 94115, United States

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Waterbury, Connecticut, 06708, United States

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Boca Raton, Florida, 33428, United States

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Miami, Florida, 33136, United States

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Chicago, Illinois, 60612-3824, United States

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Urbana, Illinois, 61801, United States

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Indianapolis, Indiana, 46303, United States

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South Bend, Indiana, 46601, United States

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Terre Haute, Indiana, 47802, United States

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Kansas City, Kansas, 66160-7136, United States

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Louisville, Kentucky, 40202, United States

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New Orleans, Louisiana, 70121, United States

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Baltimore, Maryland, 21231-1000, United States

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Boston, Massachusetts, 02215, United States

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Ann Arbor, Michigan, 48109-0942, United States

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Detroit, Michigan, 48202, United States

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Kansas City, Missouri, 64131, United States

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St Louis, Missouri, 63110, United States

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Billings, Montana, 59101, United States

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Great Falls, Montana, 59405, United States

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Lebanon, New Hampshire, 03766, United States

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East Orange, New Jersey, 07018, United States

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Morristown, New Jersey, 07960, United States

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New York, New York, 10021, United States

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Rochester, New York, 14642, United States

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The Bronx, New York, 10466, United States

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Valhalla, New York, 10595, United States

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Durham, North Carolina, 27710, United States

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Hickory, North Carolina, 28602, United States

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Cleveland, Ohio, 44195, United States

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Oklahoma City, Oklahoma, 73104, United States

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Portland, Oregon, 97213-2933, United States

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Hershey, Pennsylvania, 17033-0850, United States

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Philadelphia, Pennsylvania, 19111, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Charleston, South Carolina, 29414, United States

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Knoxville, Tennessee, 37920, United States

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Memphis, Tennessee, 38120, United States

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Nashville, Tennessee, 37232-6310, United States

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Houston, Texas, 77030, United States

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Salt Lake City, Utah, 84112, United States

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Richmond, Virginia, 23249, United States

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Seattle, Washington, 98101, United States

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Seattle, Washington, 98109-1023, United States

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Buenos, Aires, Argentina

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Buenos Aires, Buenos Aires, C1426ANZ, Argentina

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Córdoba, Córdoba Province, 5000, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Mendoza, Argentina

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Quilmes, Argentina

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Kogarah, New South Wales, 2217, Australia

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Newcastle, New South Wales, Australia

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Westmead, New South Wales, 2145, Australia

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Adelaide, South Australia, 5000, Australia

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Footscray, Victoria, 3012, Australia

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Heidelberg, Victoria, 3084, Australia

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Melbourne, Victoria, 3050, Australia

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Edmonton, Alberta, T6G 1Z2, Canada

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Kelowna, British Columbia, V1Y 5L3, Canada

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Vancouver, British Columbia, V5Z 3J5, Canada

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Winnipeg, Manitoba, R3E 0C9, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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London, Ontario, N6A 4L5, Canada

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Newmarket, Ontario, L3Y 2P9, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Montreal, Quebec, H2X 3J4, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Québec, Quebec, G1R 2J6, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Hamilton, Ontario, L8N 4A6, Canada

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Brno, 656 53, Czechia

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Prague, 150 00, Czechia

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Bonn, North Rhine-Westphalia, 53105, Germany

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Essen, North Rhine-Westphalia, 45122, Germany

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Mainz, Rhineland-Palatinate, D-55101, Germany

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Heraklion, Creete, Greece

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Pátrai, Greece

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Budapest, H-1122, Hungary

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Roma, RM, 00144, Italy

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Foggia, 71100, Italy

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Milan, 20132, Italy

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Daugavpils, Latvia

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Riga, 1002, Latvia

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Riga, 1079, Latvia

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Vilnius, 2021, Lithuania

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Monterrey, Nuevo León, 64000, Mexico

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León, 37000, Mexico

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Nijmegen, GA, 6525, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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Enschede, 7511 JX, Netherlands

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Bytom, 41-902, Poland

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Lodz, 93-509, Poland

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Lublin, 20-090, Poland

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Olsztyn, 10-228, Poland

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Opole, 45-060, Poland

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Poznan, 61-878, Poland

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Siedlce, 08-110, Poland

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Warsaw, 00-909, Poland

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Warsaw, 02-781, Poland

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Barnaul, 656052, Russia

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Kemerovo, 650003, Russia

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Moscow, 115478, Russia

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Moscow, 121356, Russia

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Moscow, 125284, Russia

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Moscow, 143423, Russia

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Obninsk, 249036, Russia

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Saint Petersburg, 188663, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 197758, Russia

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Saint Petersburg, Russia

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Ufa, 450005, Russia

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Ufa, Russia

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Sremska Kamenica, Novi Sad, 21204, Serbia and Montenegro

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Belgrade, 11000, Serbia

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Banská Bystrica, 974 01, Slovakia

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Bratislava, 833 10, Slovakia

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Martin, 03659, Slovakia

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Zlina, 012 07, Slovakia

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Port Elizabeth, Eastern Cape, 6006, South Africa

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Johannesburg, Gauteng, 2197, South Africa

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Cape Town, 7505, South Africa

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Gauteng, South Africa

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Badalona, Barcelona, 08916, Spain

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Barcelona, Barcelona, 08025, Spain

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Madrid, Madrid, 28040, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Stockholm, Sweden, 171 76, Sweden

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Gothenburg, 41345, Sweden

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Uppsala, 751 85, Sweden

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Taipei, ROC, 112, Taiwan

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Taichung, Taiwan

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Taipei, 104, Taiwan

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Taoyuan District, 333, Taiwan

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Istanbul, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Dnietropetrovsk, Ukraine

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Donetsk, 83 092, Ukraine

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Kharkiv, 61 037, Ukraine

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Kiev, 03 142, Ukraine

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Lviv, 79031, Ukraine

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Zaporizhzhya, 69103, Ukraine

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Manchester, Lancashire, M20 4BX, United Kingdom

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Glasgow, Strathclyde, G11 6NT, United Kingdom

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Sutton, Surrey, SM2 5PT, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Related Publications (5)

• 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.

  PMID: 37146227 DERIVED

• 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.

  PMID: 28410911 DERIVED

• 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.

  PMID: 27238653 DERIVED

• 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.

  PMID: 25577718 DERIVED

• 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.

  PMID: 17538086 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Interferon-alpha; temsirolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2003
• First Posted: July 25, 2003
• Study Start: July 1, 2003
• Primary Completion: June 1, 2006
• Study Completion: March 1, 2011
• Last Updated: October 25, 2012
• Results First Posted: October 25, 2012

Record last verified: 2012-09

Locations

NL (3); CZ (2); GR (2); ZA (4); US (48); RU (13); AU (7); LA (3); SE (1); ES (4); DE (3); TW (4); SL (4); UA (6); IT (3); HU (1); ME (2); LI (1); TU (2); GB (4); PL (9); AR (6); CA (16)