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

NCT ID: NCT00065468

Last Updated: 2012-10-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

626 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Renal Cell Kidney Neoplasms

Keywords

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Advanced Renal Cell Carcinoma Kidney Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Interferon Alfa

Intervention Type 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.

B

Group Type EXPERIMENTAL

CCI-779

Intervention Type DRUG

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

C

Group Type EXPERIMENTAL

Interferon Alfa and CCI-779

Intervention Type DRUG

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

Interventions

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Interferon Alfa

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.

Intervention Type DRUG

CCI-779

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

Intervention Type DRUG

Interferon Alfa and CCI-779

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Little Rock, Arkansas, United States

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La Verne, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Waterbury, Connecticut, United States

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Boca Raton, Florida, United States

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Miami, Florida, United States

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Chicago, Illinois, United States

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Urbana, Illinois, United States

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Indianapolis, Indiana, United States

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South Bend, Indiana, United States

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Terre Haute, Indiana, United States

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Kansas City, Kansas, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Great Falls, Montana, United States

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Lebanon, New Hampshire, United States

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East Orange, New Jersey, United States

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Morristown, New Jersey, United States

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New York, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Durham, North Carolina, United States

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Hickory, North Carolina, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Buenos, Aires, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Mendoza, , Argentina

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Quilmes, , Argentina

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Kogarah, New South Wales, Australia

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Newcastle, New South Wales, Australia

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Westmead, New South Wales, Australia

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Adelaide, South Australia, Australia

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Footscray, Victoria, Australia

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Heidelberg, Victoria, Australia

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Melbourne, Victoria, Australia

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Newmarket, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Hamilton, Ontario, , Canada

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Brno, , Czechia

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Prague, , Czechia

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Bonn, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Mainz, Rhineland-Palatinate, Germany

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Heraklion, Creete, Greece

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Pátrai, , Greece

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Budapest, , Hungary

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Roma, RM, Italy

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Foggia, , Italy

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Milan, , Italy

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Daugavpils, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Vilnius, , Lithuania

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Monterrey, Nuevo León, Mexico

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León, , Mexico

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Nijmegen, GA, Netherlands

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Amsterdam, , Netherlands

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Enschede, , Netherlands

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Bytom, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Olsztyn, , Poland

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Opole, , Poland

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Poznan, , Poland

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Siedlce, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Barnaul, , Russia

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Kemerovo, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Obninsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Ufa, , Russia

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Ufa, , Russia

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Sremska Kamenica, Novi Sad, Serbia and Montenegro

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Belgrade, , Serbia

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Banská Bystrica, , Slovakia

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Bratislava, , Slovakia

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Martin, , Slovakia

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Zlina, , Slovakia

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Port Elizabeth, Eastern Cape, South Africa

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Johannesburg, Gauteng, South Africa

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Cape Town, , South Africa

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Gauteng, , South Africa

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Badalona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Madrid, Madrid, Spain

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Oviedo, Principality of Asturias, Spain

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Stockholm, Sweden, Sweden

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Gothenburg, , Sweden

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Uppsala, , Sweden

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Taipei, ROC, Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Dnietropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Lviv, , Ukraine

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Zaporizhzhya, , Ukraine

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Manchester, Lancashire, United Kingdom

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Glasgow, Strathclyde, United Kingdom

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Sutton, Surrey, United Kingdom

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Nottingham, , United Kingdom

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Countries

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United States Argentina Australia Canada Czechia Germany Greece Hungary Italy Latvia Lithuania Mexico Netherlands Poland Russia Serbia and Montenegro Serbia Slovakia South Africa Spain Sweden Taiwan Turkey (Türkiye) Ukraine United Kingdom

References

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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.

Reference Type DERIVED
PMID: 37146227 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28410911 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27238653 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25577718 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17538086 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3066K1-304&StudyName=Study%20Evaluating%20Interferon%20And%20CCI-779%20In%20Advanced%20Renal%20Cell%20Carcinoma

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

Other Identifiers

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3066K1-304

Identifier Type: -

Identifier Source: org_study_id

NCT00070330

Identifier Type: -

Identifier Source: nct_alias