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Carcinoma, Renal CellPhase 2NCT00267748

Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)

A Phase 2 study testing Sunitinib Malate Continuous Daily Dosing and Sunitinib Malate Schedule 4/2 in people with Carcinoma, Renal Cell, run by Pfizer at 156 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Sunitinib Malate Continuous Daily Dosing and Sunitinib Malate Schedule 4/2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
317 participants
Where
156 sitesUnited States
Study dates
Dec 2005to Jun 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology.
  • Measurable disease

Who cannot join

  • Prior systemic therapy of any kind for advanced renal cell cancer
  • History of brain metastases
  • Uncontrolled hypertension

Trial locations and contacts

156 sites in 1 country.

156 sites in 1 country

United States156 sites

  • Pfizer Investigational Site

    Albany, New York, 12206

  • Pfizer Investigational Site

    Albany, New York, 12208

  • Pfizer Investigational Site

    Albuquerque, New Mexico, 87131-0001

  • Pfizer Investigational Site

    Amsterdam, New York, 12010

  • Pfizer Investigational Site

    Anaheim, California, 92807

  • Pfizer Investigational Site

    Aurora, Colorado, 80012

  • Pfizer Investigational Site

    Austin, Texas, 78705

  • Pfizer Investigational Site

    Austin, Texas, 78731

  • Pfizer Investigational Site

    Austin, Texas, 78745

  • Pfizer Investigational Site

    Austin, Texas, 78758

  • Pfizer Investigational Site

    Austin, Texas, 78759

  • Pfizer Investigational Site

    Baldwin Park, California, 91706

  • Pfizer Investigational Site

    Baltimore, Maryland, 21201

  • Pfizer Investigational Site

    Baltimore, Maryland, 21237

  • Pfizer Investigational Site

    Baton Rouge, Louisiana, 70809

  • Pfizer Investigational Site

    Bedford, Texas, 76022

  • Pfizer Investigational Site

    Bellflower, California, 90706

  • Pfizer Investigational Site

    Bethesda, Maryland, 20817

  • Pfizer Investigational Site

    Boca Raton, Florida, 33486

  • Pfizer Investigational Site

    Boise, Idaho, 83712

  • Pfizer Investigational Site

    Boulder, Colorado, 80303

  • Pfizer Investigational Site

    Boulder, Colorado, 80304

  • Pfizer Investigational Site

    Brockport, New York, 14420

  • Pfizer Investigational Site

    Canadaigua, New York, 14424

  • Pfizer Investigational Site

    Canton, Ohio, 44718

  • Pfizer Investigational Site

    Cary, North Carolina, 27518

  • Pfizer Investigational Site

    Cedar Rapids, Iowa, 52402

  • Pfizer Investigational Site

    Chesapeake, Virginia, 23320

  • Pfizer Investigational Site

    Clinton, North Carolina, 28328

  • Pfizer Investigational Site

    Colorado Springs, Colorado, 80909

  • Pfizer Investigational Site

    Columbus, Georgia, 31902

  • Pfizer Investigational Site

    Columbus, Georgia, 31904

  • Pfizer Investigational Site

    Columbus, Ohio, 43219

  • Pfizer Investigational Site

    Corpus Christi, Texas, 78463

  • Pfizer Investigational Site

    Covington, Louisiana, 70433

  • Pfizer Investigational Site

    Dallas, Texas, 75230

  • Pfizer Investigational Site

    Dallas, Texas, 75246

  • Pfizer Investigational Site

    Delray Beach, Florida, 33484

  • Pfizer Investigational Site

    Denver, Colorado, 80218

  • Pfizer Investigational Site

    Denver, Colorado, 80220

  • Pfizer Investigational Site

    Duarte, California, 91010

  • Pfizer Investigational Site

    Dunmore, Pennsylvania, 18512-3169

  • Pfizer Investigational Site

    Easley, South Carolina, 29640

  • Pfizer Investigational Site

    Elizabeth City, North Carolina, 27909

  • Pfizer Investigational Site

    Elkhart, Indiana, 46514

  • Pfizer Investigational Site

    Eugene, Oregon, 97401

  • Pfizer Investigational Site

    Farmington, New Mexico, 87401-5631

  • Pfizer Investigational Site

    Fontana, California, 92335

  • Pfizer Investigational Site

    Fort Worth, Texas, 76177

  • Pfizer Investigational Site

    Geneva, New York, 14456

  • Pfizer Investigational Site

    Georgetown, Texas, 78626

  • Pfizer Investigational Site

    Goldsboro, North Carolina, 27534

  • Pfizer Investigational Site

    Grand Rapids, Michigan, 49503

  • Pfizer Investigational Site

    Greenville, South Carolina, 29605

  • Pfizer Investigational Site

    Greenville, South Carolina, 29615

  • Pfizer Investigational Site

    Gretna, Louisiana, 70056

  • Pfizer Investigational Site

    Hackensack, New Jersey, 07601

  • Pfizer Investigational Site

    Hampton, Virginia, 23666

  • Pfizer Investigational Site

    Henderson, Nevada, 89052

  • Pfizer Investigational Site

    Hickory, North Carolina, 28602

  • Pfizer Investigational Site

    Holland, Michigan, 49424

  • Pfizer Investigational Site

    Hot Springs, Arkansas, 71913

  • Pfizer Investigational Site

    Hudson, New York, 12534

  • Pfizer Investigational Site

    Irvine, California, 92618

  • Pfizer Investigational Site

    Jefferson, Indiana, 47130

  • Pfizer Investigational Site

    Kokomo, Indiana, 46902-3803

  • Pfizer Investigational Site

    La Porte, Indiana, 46350-5533

  • Pfizer Investigational Site

    La Porte, Indiana, 46350

  • Pfizer Investigational Site

    Lakeland, Florida, 33805

  • Pfizer Investigational Site

    Lakewood, Colorado, 80228

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89128

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89135

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89148

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89169

  • Pfizer Investigational Site

    Latham, New York, 12110

  • Pfizer Investigational Site

    Lemoyne, Pennsylvania, 17043-1440

  • Pfizer Investigational Site

    Lexington, Kentucky, 40536-0293

  • Pfizer Investigational Site

    Lexington, Kentucky, 40536

  • Pfizer Investigational Site

    Little Rock, Arkansas, 72205

  • Pfizer Investigational Site

    Littleton, Colorado, 80120

  • Pfizer Investigational Site

    Lone Tree, Colorado, 80124

  • Pfizer Investigational Site

    Longmont, Colorado, 80501

  • Pfizer Investigational Site

    Los Angeles, California, 90027

  • Pfizer Investigational Site

    Los Angeles, California, 90034

  • Pfizer Investigational Site

    Los Angeles, California, 90095

  • Pfizer Investigational Site

    Louisville, Kentucky, 40202

  • Pfizer Investigational Site

    Louisville, Kentucky, 40207

  • Pfizer Investigational Site

    Louisville, Kentucky, 40217

  • Pfizer Investigational Site

    Madison, Wisconsin, 53792

  • Pfizer Investigational Site

    Marrero, Louisiana, 70072

  • Pfizer Investigational Site

    Metairie, Louisiana, 70006

  • Pfizer Investigational Site

    Michigan City, Indiana, 46360

  • Pfizer Investigational Site

    Morgantown, West Virginia, 26506

  • Pfizer Investigational Site

    New Orleans, Louisiana, 70115

  • Pfizer Investigational Site

    New York, New York, 10021

  • Pfizer Investigational Site

    New York, New York, 10022

  • Pfizer Investigational Site

    New York, New York, 10032

  • Pfizer Investigational Site

    Newark, Delaware, 19713

  • Pfizer Investigational Site

    Newark, Delaware, 19718

  • Pfizer Investigational Site

    Newport News, Virginia, 23502

  • Pfizer Investigational Site

    Newport News, Virginia, 23601

  • Pfizer Investigational Site

    Niles, Michigan, 49120

  • Pfizer Investigational Site

    Norfolk, Virginia, 23502

  • Pfizer Investigational Site

    Norman, Oklahoma, 73071

  • Pfizer Investigational Site

    Norwich, Connecticut, 06360

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73102

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73109

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73112-4416

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73120

  • Pfizer Investigational Site

    Orlando, Florida, 32806

  • Pfizer Investigational Site

    Panorama City, California, 91402

  • Pfizer Investigational Site

    Parker, Colorado, 80138

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19111-2497

  • Pfizer Investigational Site

    Plymouth, Indiana, 46563

  • Pfizer Investigational Site

    Pueblo, Colorado, 81008

  • Pfizer Investigational Site

    Raleigh, North Carolina, 27607

  • Pfizer Investigational Site

    Raleigh, North Carolina, 27614

  • Pfizer Investigational Site

    Rexford, New York, 12148

  • Pfizer Investigational Site

    Riverside, California, 92505

  • Pfizer Investigational Site

    Rochester, New York, 14623

  • Pfizer Investigational Site

    Rochester, New York, 14626

  • Pfizer Investigational Site

    Round Rock, Texas, 78681

  • Pfizer Investigational Site

    Saint Joseph, Michigan, 49085-2112

  • Pfizer Investigational Site

    Saint Joseph, Michigan, 49085-2158

  • Pfizer Investigational Site

    Saint Joseph, Michigan, 49085

  • Pfizer Investigational Site

    Salt Lake City, Utah, 84112

  • Pfizer Investigational Site

    San Antonio, Texas, 78207

  • Pfizer Investigational Site

    San Antonio, Texas, 78217

  • Pfizer Investigational Site

    San Antonio, Texas, 78229

  • Pfizer Investigational Site

    San Antonio, Texas, 78258

  • Pfizer Investigational Site

    San Diego, California, 92108

  • Pfizer Investigational Site

    San Diego, California, 92120

  • Pfizer Investigational Site

    Scranton, Pennsylvania, 18508

  • Pfizer Investigational Site

    Seattle, Washington, 98109

  • Pfizer Investigational Site

    Seattle, Washington, 98195

  • Pfizer Investigational Site

    Seneca, South Carolina, 29672

  • Pfizer Investigational Site

    Shelbyville, Kentucky, 40065

  • Pfizer Investigational Site

    Shreveport, Louisiana, 71103

  • Pfizer Investigational Site

    South Bend, Indiana, 46601

  • Pfizer Investigational Site

    South Bend, Indiana, 46617

  • Pfizer Investigational Site

    Spartanburg, South Carolina, 29307

  • Pfizer Investigational Site

    Springfield, Oregon, 97477

  • Pfizer Investigational Site

    St Louis, Missouri, 63141

  • Pfizer Investigational Site

    Thorton, Colorado, 80260

  • Pfizer Investigational Site

    Troy, New York, 12180

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74104

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74133

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74136-1902

  • Pfizer Investigational Site

    Tyler, Texas, 75702

  • Pfizer Investigational Site

    Virginia Beach, Virginia, 23456

  • Pfizer Investigational Site

    Washington, Missouri, 63090

  • Pfizer Investigational Site

    Webster, Texas, 77598

  • Pfizer Investigational Site

    Williamsburg, Virginia, 23188

  • Pfizer Investigational Site

    Wilmington, Delaware, 19899

  • Pfizer Investigational Site

    Wilson, North Carolina, 27893

  • Pfizer Investigational Site

    Woodland Hills, California, 91365

Other trials in United States

About this study

Official title: 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)

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.

Being tested
Sunitinib Malate Continuous Daily Dosing, Sunitinib Malate Schedule 4/2
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sunitinib Malate Continuous Daily DosingDrug

    Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.

  • Sunitinib Malate Schedule 4/2Drug

    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.

Study groups in NCT00267748
Study groupRoleWhat they receive
CExperimentalNot described
Receives: Drug: Sunitinib Malate Continuous Daily Dosing
AExperimentalNot described
Receives: Drug: Sunitinib Malate Schedule 4/2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Percentage of Participants With Objective Response (OR)

    Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

    Measured: 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

  2. Duration of Response (DR)

    Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

    Measured: 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

  3. Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model

    MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00267748
Sponsor's protocol ID
A6181065
Status last verified
Aug 2011
First submitted
20 Dec 2005
Last updated
5 Sep 2011
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28410911

  • 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.

    PubMed 27238653

  • 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.

    PubMed 25577718

  • Motzer 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.

    PubMed 25100134

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib Malate Continuous Daily Dosing and Sunitinib Malate Schedule 4/2 in people with Carcinoma, Renal Cell, run by Pfizer at 156 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00267748, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2011.

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