Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)
A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (Renal EFFECT Trial)
1 other identifier
interventional
317
1 country
156
Brief Summary
This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment. The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2005
Typical duration for phase_2
156 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 20, 2005
CompletedFirst Posted
Study publicly available on registry
December 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
September 5, 2011
CompletedSeptember 5, 2011
August 1, 2011
4.5 years
December 20, 2005
June 23, 2011
August 3, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model
MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=\>3) based on number of criteria present such as Karnofsky performance status \< 80 %, Lactate dehydrogenase \> 1.5 \* Upper limit of Normal,Hemoglobin \< lower limit of normal, serum calcium \> 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of \< 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Secondary Outcomes (3)
Percentage of Participants With Objective Response (OR)
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Duration of Response (DR)
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Other Outcomes (2)
Functional Assessment of Cancer Therapy-General (FACT-G)
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
FACT-Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS)
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Study Arms (2)
C
EXPERIMENTALA
EXPERIMENTALInterventions
Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.
Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.
Eligibility Criteria
You may qualify if:
- Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology.
- Measurable disease
You may not qualify if:
- Prior systemic therapy of any kind for advanced renal cell cancer
- History of brain metastases
- Uncontrolled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (156)
Pfizer Investigational Site
Hot Springs, Arkansas, 71913, United States
Pfizer Investigational Site
Little Rock, Arkansas, 72205, United States
Pfizer Investigational Site
Anaheim, California, 92807, United States
Pfizer Investigational Site
Baldwin Park, California, 91706, United States
Pfizer Investigational Site
Bellflower, California, 90706, United States
Pfizer Investigational Site
Duarte, California, 91010, United States
Pfizer Investigational Site
Fontana, California, 92335, United States
Pfizer Investigational Site
Irvine, California, 92618, United States
Pfizer Investigational Site
Los Angeles, California, 90027, United States
Pfizer Investigational Site
Los Angeles, California, 90034, United States
Pfizer Investigational Site
Los Angeles, California, 90095, United States
Pfizer Investigational Site
Panorama City, California, 91402, United States
Pfizer Investigational Site
Riverside, California, 92505, United States
Pfizer Investigational Site
San Diego, California, 92108, United States
Pfizer Investigational Site
San Diego, California, 92120, United States
Pfizer Investigational Site
Woodland Hills, California, 91365, United States
Pfizer Investigational Site
Aurora, Colorado, 80012, United States
Pfizer Investigational Site
Boulder, Colorado, 80303, United States
Pfizer Investigational Site
Boulder, Colorado, 80304, United States
Pfizer Investigational Site
Colorado Springs, Colorado, 80909, United States
Pfizer Investigational Site
Denver, Colorado, 80218, United States
Pfizer Investigational Site
Denver, Colorado, 80220, United States
Pfizer Investigational Site
Lakewood, Colorado, 80228, United States
Pfizer Investigational Site
Littleton, Colorado, 80120, United States
Pfizer Investigational Site
Lone Tree, Colorado, 80124, United States
Pfizer Investigational Site
Longmont, Colorado, 80501, United States
Pfizer Investigational Site
Parker, Colorado, 80138, United States
Pfizer Investigational Site
Pueblo, Colorado, 81008, United States
Pfizer Investigational Site
Thorton, Colorado, 80260, United States
Pfizer Investigational Site
Norwich, Connecticut, 06360, United States
Pfizer Investigational Site
Newark, Delaware, 19713, United States
Pfizer Investigational Site
Newark, Delaware, 19718, United States
Pfizer Investigational Site
Wilmington, Delaware, 19899, United States
Pfizer Investigational Site
Boca Raton, Florida, 33486, United States
Pfizer Investigational Site
Delray Beach, Florida, 33484, United States
Pfizer Investigational Site
Lakeland, Florida, 33805, United States
Pfizer Investigational Site
Orlando, Florida, 32806, United States
Pfizer Investigational Site
Columbus, Georgia, 31902, United States
Pfizer Investigational Site
Columbus, Georgia, 31904, United States
Pfizer Investigational Site
Boise, Idaho, 83712, United States
Pfizer Investigational Site
Elkhart, Indiana, 46514, United States
Pfizer Investigational Site
Jefferson, Indiana, 47130, United States
Pfizer Investigational Site
Kokomo, Indiana, 46902-3803, United States
Pfizer Investigational Site
La Porte, Indiana, 46350-5533, United States
Pfizer Investigational Site
La Porte, Indiana, 46350, United States
Pfizer Investigational Site
Michigan City, Indiana, 46360, United States
Pfizer Investigational Site
Plymouth, Indiana, 46563, United States
Pfizer Investigational Site
South Bend, Indiana, 46601, United States
Pfizer Investigational Site
South Bend, Indiana, 46617, United States
Pfizer Investigational Site
Cedar Rapids, Iowa, 52402, United States
Pfizer Investigational Site
Lexington, Kentucky, 40536-0293, United States
Pfizer Investigational Site
Lexington, Kentucky, 40536, United States
Pfizer Investigational Site
Louisville, Kentucky, 40202, United States
Pfizer Investigational Site
Louisville, Kentucky, 40207, United States
Pfizer Investigational Site
Louisville, Kentucky, 40217, United States
Pfizer Investigational Site
Shelbyville, Kentucky, 40065, United States
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809, United States
Pfizer Investigational Site
Covington, Louisiana, 70433, United States
Pfizer Investigational Site
Gretna, Louisiana, 70056, United States
Pfizer Investigational Site
Marrero, Louisiana, 70072, United States
Pfizer Investigational Site
Metairie, Louisiana, 70006, United States
Pfizer Investigational Site
New Orleans, Louisiana, 70115, United States
Pfizer Investigational Site
Shreveport, Louisiana, 71103, United States
Pfizer Investigational Site
Baltimore, Maryland, 21201, United States
Pfizer Investigational Site
Baltimore, Maryland, 21237, United States
Pfizer Investigational Site
Bethesda, Maryland, 20817, United States
Pfizer Investigational Site
Grand Rapids, Michigan, 49503, United States
Pfizer Investigational Site
Holland, Michigan, 49424, United States
Pfizer Investigational Site
Niles, Michigan, 49120, United States
Pfizer Investigational Site
Saint Joseph, Michigan, 49085-2112, United States
Pfizer Investigational Site
Saint Joseph, Michigan, 49085-2158, United States
Pfizer Investigational Site
Saint Joseph, Michigan, 49085, United States
Pfizer Investigational Site
St Louis, Missouri, 63141, United States
Pfizer Investigational Site
Washington, Missouri, 63090, United States
Pfizer Investigational Site
Henderson, Nevada, 89052, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89128, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89135, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89148, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89169, United States
Pfizer Investigational Site
Hackensack, New Jersey, 07601, United States
Pfizer Investigational Site
Albuquerque, New Mexico, 87131-0001, United States
Pfizer Investigational Site
Farmington, New Mexico, 87401-5631, United States
Pfizer Investigational Site
Albany, New York, 12206, United States
Pfizer Investigational Site
Albany, New York, 12208, United States
Pfizer Investigational Site
Amsterdam, New York, 12010, United States
Pfizer Investigational Site
Brockport, New York, 14420, United States
Pfizer Investigational Site
Canadaigua, New York, 14424, United States
Pfizer Investigational Site
Geneva, New York, 14456, United States
Pfizer Investigational Site
Hudson, New York, 12534, United States
Pfizer Investigational Site
Latham, New York, 12110, United States
Pfizer Investigational Site
New York, New York, 10021, United States
Pfizer Investigational Site
New York, New York, 10022, United States
Pfizer Investigational Site
New York, New York, 10032, United States
Pfizer Investigational Site
Rexford, New York, 12148, United States
Pfizer Investigational Site
Rochester, New York, 14623, United States
Pfizer Investigational Site
Rochester, New York, 14626, United States
Pfizer Investigational Site
Troy, New York, 12180, United States
Pfizer Investigational Site
Cary, North Carolina, 27518, United States
Pfizer Investigational Site
Clinton, North Carolina, 28328, United States
Pfizer Investigational Site
Elizabeth City, North Carolina, 27909, United States
Pfizer Investigational Site
Goldsboro, North Carolina, 27534, United States
Pfizer Investigational Site
Hickory, North Carolina, 28602, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27607, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27614, United States
Pfizer Investigational Site
Wilson, North Carolina, 27893, United States
Pfizer Investigational Site
Canton, Ohio, 44718, United States
Pfizer Investigational Site
Columbus, Ohio, 43219, United States
Pfizer Investigational Site
Norman, Oklahoma, 73071, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73102, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73109, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112-4416, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73120, United States
Pfizer Investigational Site
Tulsa, Oklahoma, 74104, United States
Pfizer Investigational Site
Tulsa, Oklahoma, 74133, United States
Pfizer Investigational Site
Tulsa, Oklahoma, 74136-1902, United States
Pfizer Investigational Site
Eugene, Oregon, 97401, United States
Pfizer Investigational Site
Springfield, Oregon, 97477, United States
Pfizer Investigational Site
Dunmore, Pennsylvania, 18512-3169, United States
Pfizer Investigational Site
Lemoyne, Pennsylvania, 17043-1440, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111-2497, United States
Pfizer Investigational Site
Scranton, Pennsylvania, 18508, United States
Pfizer Investigational Site
Easley, South Carolina, 29640, United States
Pfizer Investigational Site
Greenville, South Carolina, 29605, United States
Pfizer Investigational Site
Greenville, South Carolina, 29615, United States
Pfizer Investigational Site
Seneca, South Carolina, 29672, United States
Pfizer Investigational Site
Spartanburg, South Carolina, 29307, United States
Pfizer Investigational Site
Austin, Texas, 78705, United States
Pfizer Investigational Site
Austin, Texas, 78731, United States
Pfizer Investigational Site
Austin, Texas, 78745, United States
Pfizer Investigational Site
Austin, Texas, 78758, United States
Pfizer Investigational Site
Austin, Texas, 78759, United States
Pfizer Investigational Site
Bedford, Texas, 76022, United States
Pfizer Investigational Site
Corpus Christi, Texas, 78463, United States
Pfizer Investigational Site
Dallas, Texas, 75230, United States
Pfizer Investigational Site
Dallas, Texas, 75246, United States
Pfizer Investigational Site
Fort Worth, Texas, 76177, United States
Pfizer Investigational Site
Georgetown, Texas, 78626, United States
Pfizer Investigational Site
Round Rock, Texas, 78681, United States
Pfizer Investigational Site
San Antonio, Texas, 78207, United States
Pfizer Investigational Site
San Antonio, Texas, 78217, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
San Antonio, Texas, 78258, United States
Pfizer Investigational Site
Tyler, Texas, 75702, United States
Pfizer Investigational Site
Webster, Texas, 77598, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84112, United States
Pfizer Investigational Site
Chesapeake, Virginia, 23320, United States
Pfizer Investigational Site
Hampton, Virginia, 23666, United States
Pfizer Investigational Site
Newport News, Virginia, 23502, United States
Pfizer Investigational Site
Newport News, Virginia, 23601, United States
Pfizer Investigational Site
Norfolk, Virginia, 23502, United States
Pfizer Investigational Site
Virginia Beach, Virginia, 23456, United States
Pfizer Investigational Site
Williamsburg, Virginia, 23188, United States
Pfizer Investigational Site
Seattle, Washington, 98109, United States
Pfizer Investigational Site
Seattle, Washington, 98195, United States
Pfizer Investigational Site
Morgantown, West Virginia, 26506, United States
Pfizer Investigational Site
Madison, Wisconsin, 53792, United States
Related Publications (4)
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: 28410911DERIVEDGrunwald 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: 27238653DERIVEDGrunwald 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: 25577718DERIVEDMotzer RJ, Hutson TE, Hudes GR, Figlin RA, Martini JF, English PA, Huang X, Valota O, Williams JA. Investigation of novel circulating proteins, germ line single-nucleotide polymorphisms, and molecular tumor markers as potential efficacy biomarkers of first-line sunitinib therapy for advanced renal cell carcinoma. Cancer Chemother Pharmacol. 2014 Oct;74(4):739-50. doi: 10.1007/s00280-014-2539-0. Epub 2014 Aug 7.
PMID: 25100134DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 20, 2005
First Posted
December 21, 2005
Study Start
December 1, 2005
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
September 5, 2011
Results First Posted
September 5, 2011
Record last verified: 2011-08