SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

NCT00083889 | Completed Phase 3 Results DMC

• 1 other identifier: A6181034
• Study Type: interventional
• Target: 750
• Locations: 11 countries
• Sites: 123

Brief Summary

The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS), Core Radiology Assessment

  Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods.

  Day 28 of each 6-week cycle: duration of treatment phase

• Progression-Free Survival (PFS), Investigator's Assessment

  Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods.

  Day 28 of each 6-week cycle: duration of treatment phase

Secondary Outcomes (22)

• Objective Response, Core Radiology Assessment

  Day 28 of each 6-week cycle: duration of treatment phase

• Objective Response, Investigator's Assessment

  Day 28 of each 6-week cycle: duration of treatment phase

• Overall Survival (OS)

  Clinic visit or telephone contact every 2 months until death

• Time to Tumor Progression (TTP), Core Radiology Assessment

  Randomization to first documentation of tumor progression: duration of treatment phase

• Time to Tumor Progression (TTP), Investigator's Assessment

  Randomization to first documentation of tumor progression: duration of treatment phase

Study Arms (2)

2

ACTIVE COMPARATOR

Drug: Interferon-alfa

1

EXPERIMENTAL

Drug: SU011248

Interventions

Interferon-alfa DRUG

3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity

Also known as: Roferon

2

SU011248 DRUG

50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity

Also known as: Sunitinib, SUTENT

1

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed renal cell carcinoma of clear cell histology with metastases
• Evidence of measurable disease by radiographic technique
• Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 or 1

You may not qualify if:

• Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
• History of or known brain metastases
• Serious acute or chronic illness or recent history of significant cardiac abnormality

Sponsors & Collaborators

• Pfizer: lead

Study Sites (123)

Pfizer Investigational Site

Jonesboro, Arkansas, 72401, United States

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La Jolla, California, 92037, United States

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La Jolla, California, 92093, United States

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Los Angeles, California, 90095, United States

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San Diego, California, 92103, United States

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San Francisco, California, 94115, United States

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Aurora, Colorado, 80040-0510, United States

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New Haven, Connecticut, 06504, United States

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New Haven, Connecticut, 06511, United States

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New Haven, Connecticut, 06520, United States

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Miami, Florida, 33136, United States

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Miami, Florida, 33176, United States

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Tampa, Florida, 33612, United States

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Chicago, Illinois, 60611, United States

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Maywood, Illinois, 60153, United States

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Kansas City, Kansas, 66112, United States

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Overland Park, Kansas, 66210, United States

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Louisville, Kentucky, 40207, United States

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Covington, Louisiana, 70433, United States

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Metairie, Louisiana, 70002, United States

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Metairie, Louisiana, 70006, United States

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Baltimore, Maryland, 21287, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02115, United States

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Detoit, Michigan, 48201, United States

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Detroit, Michigan, 48201, United States

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Farmington Hills, Michigan, 48334, United States

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Minneapolis, Minnesota, 55455, United States

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Columbus, Mississippi, 39705, United States

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Corinth, Mississippi, 38834, United States

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Jackson, Mississippi, 39213, United States

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Jackson, Mississippi, 39216, United States

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Southaven, Mississippi, 38671, United States

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Tupelo, Mississippi, 38801, United States

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Kansas City, Missouri, 64131, United States

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Omaha, Nebraska, 68198-9200, United States

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Lebanon, New Hampshire, 03756, United States

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New York, New York, 10021, United States

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New York, New York, 10022, United States

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The Bronx, New York, 10466, United States

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Cleveland, Ohio, 44106-5055, United States

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Cleveland, Ohio, 44195, United States

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Tulsa, Oklahoma, 74104, United States

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Tulsa, Oklahoma, 74133, United States

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Tulsa, Oklahoma, 74136, United States

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Portland, Oregon, 97210, United States

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Portland, Oregon, 97239, United States

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Philadelphia, Pennsylvania, 19111-2497, United States

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Memphis, Tennessee, 38104, United States

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Memphis, Tennessee, 38120, United States

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Nashville, Tennessee, 37232, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77030, United States

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Tyler, Texas, 75702, United States

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Salt Lake City, Utah, 84112, 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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Madison, Wisconsin, 53792-0001, United States

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Lismore, New South Wales, 2480, Australia

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St Leonards, New South Wales, 2065, Australia

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South Brisbane, Queensland, 4101, Australia

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Woodville South, South Australia, 5011, Australia

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East Melbourne, Victoria, 3002, Australia

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Perth, Western Australia, 6000, Australia

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Victoria, 36184, Australia

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Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil

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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Calgary, Alberta, T2N 4N2, Canada

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Edmonton, Alberta, T6G 1Z2, Canada

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Kelowna, British Columbia, V1Y5L3, Canada

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Vancouver, British Columbia, V5Z 4E6, Canada

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Victoria, British Columbia, V5Z 4E6, Canada

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London, Ontario, N6A 4L6, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Québec, Quebec, G1R 2J6, Canada

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Québec, Quebec, G1S 2L6, Canada

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Paris, Cedex 15, 75908, France

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Lyon, 69008, France

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Paris, 75651, France

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Rennes, 35042, France

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Saint-Herblain, France

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Vandœuvre-lès-Nancy, 54511, France

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Aachen, 52074, Germany

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Essen, 45122, Germany

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Hanover, 30625, Germany

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Ulm, 89075, Germany

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Ulm, 89081, Germany

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Modena, 41100, Italy

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Napoli, 80131, Italy

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Pavia, Italy

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Roma, 00135, Italy

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Roma, 00144, Italy

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Roma, 00152, Italy

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Moczowego, Warszawa, Poland

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Gdansk, 80-210, Poland

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Krakow, 31-115, Poland

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Lodz, 93-509, Poland

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Lublin, 20-090, Poland

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Poznan, Poland

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Warsaw, 00-909, Poland

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Wroclaw, 50-043, Poland

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Wroclaw, 50-556, Poland

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Obninsk, Kaluga Oblast, 249036, Russia

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Chelyabinsk, 454087, Russia

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Moscow, 115478, Russia

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Moscow, 117836, Russia

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Moscow, Russia

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Saint Petersburg, 197758, Russia

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Tomsk, 634050, Russia

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Madrid, Madrid, 28040, Spain

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Madrid, Madrid, 28041, Spain

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Pamplona, Navarre, 31008, Spain

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Seville, SEVILLA, 41013, Spain

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Whitchurch, Cardiff, CF14 2 TL, United Kingdom

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Manchester, Lancashire, M20 4BX, United Kingdom

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Northwood, Middlesex, HA6 2RN, United Kingdom

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London, SE1 9RT, United Kingdom

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London, SW3 6JJ, United Kingdom

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Sutton Surrey, SM2 5PT, United Kingdom

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Related Publications (6)

• Rini BI, Hutson TE, Figlin RA, Lechuga MJ, Valota O, Serfass L, Rosbrook B, Motzer RJ. Sunitinib in Patients With Metastatic Renal Cell Carcinoma: Clinical Outcome According to International Metastatic Renal Cell Carcinoma Database Consortium Risk Group. Clin Genitourin Cancer. 2018 Aug;16(4):298-304. doi: 10.1016/j.clgc.2018.04.005. Epub 2018 May 4.

  PMID: 29853320 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

• Cella D, Michaelson MD, Bushmakin AG, Cappelleri JC, Charbonneau C, Kim ST, Li JZ, Motzer RJ. Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-alpha in a phase III trial: final results and geographical analysis. Br J Cancer. 2010 Feb 16;102(4):658-64. doi: 10.1038/sj.bjc.6605552. Epub 2010 Jan 26.

  PMID: 20104222 DERIVED

• Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24. doi: 10.1056/NEJMoa065044.

  PMID: 17215529 DERIVED

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Interferon-alpha; Interferon alpha-2; Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney 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; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

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

ClinicalTrials.govCallCenter@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

Study Record Dates

• First Submitted: June 3, 2004
• First Posted: June 4, 2004
• Study Start: August 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 26, 2010
• Results First Posted: December 10, 2009

Record last verified: 2010-01

Locations

CA (11); US (58); DE (5); RU (7); AU (7); ES (5); GB (6); BR (3); IT (6); PL (9); FR (6)