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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00083889

Purpose

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).

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: Interferon-alfa Drug: SU011248	Phase III

Drug Information available for: Sunitinib Sunitinib malate Interferon alfa-n1 Interferon alfa-2a Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

Further study details as provided by Pfizer:

Primary Outcome Measures:

To compare the progression-free survival in patients treated with SU011248 vs interferon-alfa as first-line systemic therapy [ Time Frame: 4 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the following between the two treatment groups - objective response rate, overall survival, duration of response, patient-reported outcomes, and safety [ Time Frame: 4 yrs ] [ Designated as safety issue: No ]

Enrollment:	750
Study Start Date:	August 2004
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator	Drug: Interferon-alfa 3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity
1: Experimental	Drug: SU011248 50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed renal cell carcinoma of clear cell histology with metastases
Evidence of measurable disease by radiographic technique
ECOG performance status of 0 or 1

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083889

Show 121 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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.

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181034
Study First Received:	June 3, 2004
Last Updated:	January 4, 2009
ClinicalTrials.gov Identifier:	NCT00083889
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Interferon-alpha
Interferon Type I, Recombinant
Interferons
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases

Sunitinib
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Interferon Alfa-2a
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antiviral Agents

Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009