Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer

NCT ID: NCT00988208

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1059 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-11
• Study Completion Date: 2016-11-28

Brief Summary

The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer.

The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.

Detailed Description

In November 2011, the Data Monitoring Committee concluded it was unlikely that the study would meet its primary endpoint of overall survival (OS) and recommended that the study be stopped. The study was terminated in accordance with this recommendation. All sites were instructed to immediately discontinue all patients from experimental lenalidomide/placebo treatment administered either in combination with chemotherapy or as a single agent following chemotherapy discontinuation. Subsequently, Protocol Amendment 3 was issued to provide for the following:

To continue to collect information on Second Primary Malignancies (SPMs) and additional treatments for Prostate Cancer in all randomized subjects during survival follow-up.

To continue to provide docetaxel and prednisone for up to 10 cycles to subjects randomized at non-US sites who were ongoing in the CC-5013-PC-002 protocol when the decision was made to discontinue lenalidomide/placebo and who were experiencing benefit as per investigator discretion. For subjects who had exceeded 10 cycles of docetaxel and prednisone at the time of Protocol Amendment 3 approval, an additional two cycles were provided.

All references to dosing and study procedures pertaining to the safety, efficacy, and exploratory endpoints of lenalidomide/placebo were discontinued as part of Protocol Amendment 3.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Docetaxel, Prednisone, Lenalidomide (DPL)

25 mg lenalidomide orally once each day on Days 1-14; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice daily on each day of the treatment cycle

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

25 mg lenalidomide orally once each day on Days 1-14

Docetaxel

Intervention Type: DRUG

75 mg/m2 intravenous docetaxel on Day 1

Prednisone

Intervention Type: DRUG

5 mg prednisone orally twice daily on each day of the treatment cycle

Docetaxel and Prednisone (DP)

Oral placebo once each day on Days 1-14 of the treatment cycle; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice each day on each day of the treatment cycle

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

75 mg/m2 intravenous docetaxel on Day 1

Prednisone

Intervention Type: DRUG

5 mg prednisone orally twice daily on each day of the treatment cycle

Placebo

Intervention Type: DRUG

Oral placebo once each day on Days 1-14 of the treatment cycle

Interventions

Lenalidomide

25 mg lenalidomide orally once each day on Days 1-14

Intervention Type: DRUG

Docetaxel

75 mg/m2 intravenous docetaxel on Day 1

Intervention Type: DRUG

Prednisone

5 mg prednisone orally twice daily on each day of the treatment cycle

Intervention Type: DRUG

Placebo

Oral placebo once each day on Days 1-14 of the treatment cycle

Intervention Type: DRUG

Other Intervention Names

CC-5013; Revlimid; Taxotere; There are multiple brand names for prednisone.

Eligibility Criteria

Inclusion Criteria

1. Must sign an Informed Consent Form (ICF)

2. Males ≥ 18 years of age

3. Able to adhere to the study visit schedule and requirements of the protocol

4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

5. Life expectancy of ≥ 12 weeks

6. Willingness to participate in Patient-Reported Outcomes assessments

7. Serum testosterone levels < 50 ng/dL

8. Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy

9. Have documented disease progression while receiving or following hormonal therapy as determined by increasing Serum Prostate Specific Antigen (PSA) level, Radiological Progression, or ≥2 new bone lesions

10. Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide

11. Refrain from donating blood or semen as defined by protocol

Exclusion Criteria

1. A history of clinically significant disease that places subject at an unacceptable risk for study entry

2. Prior Therapy with thalidomide, lenalidomide or pomalidomide

3. Prior chemotherapy for prostate cancer

4. Use of any other experimental drug or therapy within 28 days prior to randomization

5. Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior to randomization

6. Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization

7. Surgery within 28 days prior to randomization

8. Concurrent anti-androgen therapy

9. Abnormal serum chemistry or hematology laboratory values

10. Significant active cardiac disease within the previous 6 months:

11. Thrombotic or thromboembolic events within the past 6 months:

12. History of peripheral neuropathy of ≥grade 2

13. History of severe hypersensitivity reaction to drugs formulated with polysorbate 80

14. Paraplegia

15. History of Central nervous system (CNS) or brain metastases

16. History of malignancies other than prostate cancer within the past 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin

17. Concurrent use of alternative cancer therapies

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debora Barton, MD

Role: STUDY_DIRECTOR

Celgene Corporation

Locations

Hematology Oncology Associates

Phoenix, Arizona, United States

Northern AZ Hematology and Oncology Assoc

Sedona, Arizona, United States

Arizona Oncology

Tucson, Arizona, United States

City of Hope Cancer Center

Duarte, California, United States

Southwest Cancer Center - Escondido

Escondido, California, United States

Scripps Cancer Center - Clinical Research

La Jolla, California, United States

VA Long Beach Healthcare System

Long Beach, California, United States

The Angeles Clinc and Research Institute

Los Angeles, California, United States

University of Southern California

Los Angeles, California, United States

Prostate Oncology Specialists

Marina del Rey, California, United States

Stanford University Medical Center

Stanford, California, United States

Rocky Mountain Cancer Centers-Colorado Springs Circle

Colorado Springs, Colorado, United States

Washington Cancer Institute

Washington D.C., District of Columbia, United States

Melbourne Internal Medicine Associates

Melbourne, Florida, United States

Advanced Medical Specialties

Miami, Florida, United States

Florida Cancer Institute - New Hope

New Port Richey, Florida, United States

Ocala Oncology Center

Ocala, Florida, United States

Cancer Centers of Florida, P.A.- West Gore Street

Orlando, Florida, United States

South Florida Oncology - Hematology

Tamarac, Florida, United States

Palm Beach Cancer Institute, LLC

West Palm Beach, Florida, United States

Cancer Care and Hematology Specialists of Chicagoland

Niles, Illinois, United States

Lutheran General Hospital

Park Ridge, Illinois, United States

Indiana University Health

Indianapolis, Indiana, United States

Hematology and Oncology Specialist, LLC

Metairie, Louisiana, United States

Maryland Oncology Hematology PA

Columbia, Maryland, United States

Minnesota Oncology Hematology, PA

Minneapolis, Minnesota, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Summit Medical Group Overlook Oncology Center

Berkeley Heights, New Jersey, United States

Hematology-Oncology Associates of NNJ, P

Morristown, New Jersey, United States

Hematology Oncology Associates of South Jersey

Mount Holly, New Jersey, United States

New York Oncology Hematology P.C.

Albany, New York, United States

Columbia Univ Medical Center

New York, New York, United States

Weill Cornell Medical College Dr. Feldman's Office

New York, New York, United States

New Bern Cancer Care

New Bern, North Carolina, United States

Cancer Centers of North Carolina

Raleigh, North Carolina, United States

Mid Dakota Clinic, PC

Bismarck, North Dakota, United States

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States

Northwest Cancer Specialists-Tualatin

Tualatin, Oregon, United States

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, United States

South Carolina Oncology Associates, PA

Columbia, South Carolina, United States

Cancer Center of the Carolinas

Greer, South Carolina, United States

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, United States

Cookeville Regional Medical Center

Cookeville, Tennessee, United States

Sarah Cannon Research Institute UK

Nashville, Tennessee, United States

Texas Oncology, P.A.-Amarillo

Amarillo, Texas, United States

Texas Oncology-Arlington South

Arlington, Texas, United States

Texas Oncology, PA

Austin, Texas, United States

Baylor Sammons Cancer Center

Dallas, Texas, United States

Texas Oncology, P.A.-Fort Worth

Fort Worth, Texas, United States

Longview Cancer Center

Longview, Texas, United States

Allison Cancer Center

Midland, Texas, United States

Texas Oncology, P.A. - Paris

Paris, Texas, United States

Southlake Oncology

Southlake, Texas, United States

Texas Oncology, P.A. - Tyler

Tyler, Texas, United States

Texas Oncology Deke Slayton Cancer Center

Webster, Texas, United States

Texas Oncology-Texoma Cancer Center

Wichita Falls, Texas, United States

Veterans Education and Research Association of Northern New England, Inc.

White River Junction, Vermont, United States

Cancer Outreach Associates

Abingdon, Virginia, United States

Fairfax Northern Virginia Hematology Oncology

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Virginia Cancer Institute

Richmond, Virginia, United States

Oncology and Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, United States

Columbia Basin Hematology and Oncology

Kennewick, Washington, United States

VA Puget Sound HCS Seattle Division

Seattle, Washington, United States

Evergreen Hematology and Oncology

Spokane, Washington, United States

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Flinders Medical Centre

Bedford Park, , Australia

Chris O'Brien Lifehouse

Camperdown, , Australia

Sir Charles Gairdner Hospital

Nedlands, , Australia

Port Macquarie Base Hospital

Port Macquarie, , Australia

Redcliffe Hospital

Redcliffe, , Australia

Royal North Shore Hospital

St Leonards, , Australia

Newcastle Calvary Mater Hospital

Waratah, , Australia

Westmead Hospital

Westmead, , Australia

Border Medical Oncology

Wodonga, , Australia

The Queen Elizabeth Hospital

Woodville South, , Australia

Princess Alexandra Hospital

Woolloongabba, , Australia

Medical University of Graz

Graz, , Austria

Landeskrankenhaus Salzburg

Salzburg, , Austria

Krankenhaus der Barmherzigen Brueder

Vienna, , Austria

Medizinische Universitat Wien

Vienna, , Austria

ZNA Middelheim

Antwerp, , Belgium

Hopital Erasme

Brussels, , Belgium

Edith Cavell Clinic

Brussels, , Belgium

AZ Groeninge

Kortrijk, , Belgium

UZ Leuven

Leuven, , Belgium

AZ Nikolaas

Sint-Niklaas, , Belgium

The Health Institute for Men CMX Research Inc

Toronto, Ontario, Canada

Les Urologues Specialises

Montreal, Quebec, Canada

Krajska zdravotni, a.s. Nemocnice Chomutov, o.z.

Chomutov, , Czechia

Fakultni nemocnice Motol

Prague, , Czechia

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La

Ústí nad Labem, , Czechia

Arhus Universitets hospital

Aarhus C, , Denmark

Rigshospitalet University Hospital

Copenhagen, , Denmark

Herlev Hospital

Herlev, , Denmark

Odense Universitetshospital

Odense C, , Denmark

CRLCC Paul Papin

Angers, , France

Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

Bordeaux, , France

Centre Georges Francois Leclerc

Dijon, , France

Clinique Victor Hugo

Le Mans, , France

Centre Oscar Lambret

Lille, , France

Centre Leon Berard

Lyon, , France

Clinique de Valdegour

Nîmes, , France

CHU de Poitiers

Poitiers, , France

Centre Eugene Marquis

Rennes, , France

Institut de Cancerologie de la Loire

Saint Priest En Jaroz, , France

CRLCC Centre Rene Gauducheau

Saint-Herblain, , France

Hopital Civil de Strasbourg

Strasbourg, , France

CHRU Hopital Bretonneau

Tours, , France

Institut Gustave Roussy

Villejuif, , France

Vivantes Klinikum am Urban

Berlin, , Germany

Medizinisches Zentrum Bonn-Friedensplatz

Bonn, , Germany

Diakonissenkrankenhaus Dessau gGmbH

Dessau, , Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, , Germany

Krankenhaus Nordwest

Frankfurt a.M., , Germany

Onkologische Praxis Freiburg

Freiburg im Breisgau, , Germany

Universitatsklinikum Hamburg-Eppendorf / IVDP

Hamburg, , Germany

IORC- Innovation Onkologie Research and Consulting GmbH

Hamburg, , Germany

Praxis fuer Haematologie und Onkologie Koblenz

Koblenz, , Germany

Vituro GmbH & Co KG

Leipzig, , Germany

TU München - Klinikum rechts der Isar

München, , Germany

Universitaetsklinikum Muenster

Münster, , Germany

University-Hospital Tübingen

Tübingen, , Germany

Universitatsklinikum Ulm

Ulm, , Germany

Alexandra General Hospital of Athens

Athens, , Greece

Agioi Anargyroi Hospital

Athens, , Greece

University Hospital of Larissa

Larissa, , Greece

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, , Greece

Fovarosi Onkirmanyzat Peterfy S.Utcai Korhaz-Rend.Int es Baleseti Kozp.

Budapest, , Hungary

Fovarosi Onkormanyzat Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, , Hungary

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

Miskolc, , Hungary

Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar

Pécs, , Hungary

The Soroka University Medical Center

Beersheba, , Israel

Rambam Health Care Campus

Haifa, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Assaf Harofeh Medical Center

Ẕerifin, , Israel

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, , Italy

Ordine Mauriziano

Candiolo, , Italy

Azienda Ospedaliera Istituti Ospitalieri di Cremona

Cremona, , Italy

Ospedale Vito Fazzi

Lecce, , Italy

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

Meldola, , Italy

Ospedale di Mirano

Mirano (VE), , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Ospedale degli Infermi di Rimini

Rimini, , Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, , Italy

Azienda Ospedaliero-Universitaria Santa Maria della Miserico

Udine, , Italy

Hospital Angeles Lindavista

D.F, DF, , Mexico

Consultorio de Especialidad en Urologia Privado

Durango, DGO, , Mexico

Hospital Fatima

Sinaloa, SIN, , Mexico

Consultorio Privado- Dr Jose Arturo Rodriguez Rivera

Zapopan, JAL, , Mexico

VU University Medical Center VU Medisch Centrum

Amsterdam, , Netherlands

Ziekenhuis Rijnstate

Arhem, , Netherlands

Amphia Ziekenhuis Molengracht

Breda, , Netherlands

Gemini Ziekenhuis

Den Helder, , Netherlands

Albert Schweitzer Ziekenhuis Amstelwijck

Dordrecht, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Leids Universitair Medisch Centrum

Leiden, , Netherlands

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, , Netherlands

Erasmus Medical Center

Rotterdam, , Netherlands

Erasmus Medisch Centrum

Rotterdam, , Netherlands

HagaZiekenhuis

The Hague, , Netherlands

Twee Steden Ziekenhuis Tilburg

Tilburg, , Netherlands

VieCuri Medisch Centrum Venlo

Venlo, , Netherlands

Isala Klinieken

Zwolle, , Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Regionalny Osrodek Onkologiczny WSS im. M. Kopernika

Lodz, , Poland

ZOZ MSWiA z Warminsko- Mazurskim Centrum Onkologii

Olsztyn, , Poland

NZOZ Olsztynski Osr. Onkologiczny Kopernik Sp.z o.o

Olsztyn, , Poland

SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku

Rybnik, , Poland

Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie

Warsaw, , Poland

4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

Wroclaw, , Poland

Moscow Oncology Clinical Dispensary 1

Moscow, , Russia

Medical Radiology Research Centre RAMS

Obninsk, , Russia

State Institution of Heath Omsk Regional Oncology Dispensary

Omsk, , Russia

Russian Scientific Center for Radiology and Surgical Technol, St. Petersburg

Pesochny Vlg Saint Petersburg, , Russia

NSHI Dorozhnaya Clinical Hospital of OAO Russian Railways

Rostov-on-Don, , Russia

Oncology Dispensary 2 of Krasnodar Region

Sochi, , Russia

Yaroslavl Regional Clinical Oncology Hospital

Yaroslavl, , Russia

Groote Schuur Hospital

Cape Town, W Cape, , South Africa

The Oncology Centre Durban

Durban, KZ-Natal, , South Africa

Westridge Medical Centre

Durban, KZ-Natal, , South Africa

Netcare Oncology and Interventional Centre

Goodwood, W Cape, , South Africa

Dr. H. Malan

Polokwane, , South Africa

Pretoria Urology Hospital

Pretoria, , South Africa

Hospital del Mar

Barcelona, , Spain

Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO

Hospitalet de Llobregat, Barcelona, , Spain

Hospital Arnau de Vilanova

Lleida, , Spain

Hospital 12 de Octobre

Madrid, , Spain

HCU Virgen de la Victoria

Málaga, , Spain

Clinica Universitaria de Navarra

Pamplona, , Spain

Hospital Mutua de Terrassa

Terrassa (Barcelona), , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Lanssjukhuset Ryhov

Jönköping, , Sweden

Norrlands Universitetssjukhus

Umeå, , Sweden

Centrallasarettet Vasteras

Västerås, , Sweden

Clatterbridge Centre for Oncology NHS Trust

Bebington, Wirral, , United Kingdom

Addenbrookes Hospital

Cambridge, , United Kingdom

Royal Surrey County Hospital

Guildford, , United Kingdom

Guy's and St Thomas' Hospital - London

London, , United Kingdom

St George's Hospital

London, , United Kingdom

Royal Marsden Hospital

London, , United Kingdom

Christie NHS Trust Hospital

Manchester, , United Kingdom

Nottingham City Hospital

Nottingham, , United Kingdom

Northern Lincolnshire and Goole Hospitals NHS Foundation Trust

Scunthorpe, , United Kingdom

Royal Marsden Hospital

Sutton, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; Czechia; Denmark; France; Germany; Greece; Hungary; Israel; Italy; Mexico; Netherlands; Poland; Russia; South Africa; Spain; Sweden; United Kingdom

References

Vogelzang NJ, Fizazi K, Burke JM, De Wit R, Bellmunt J, Hutson TE, Crane E, Berry WR, Doner K, Hainsworth JD, Wiechno PJ, Liu K, Waldman MF, Gandhi A, Barton D, Jungnelius U, Fandi A, Sternberg CN, Petrylak DP. Circulating Tumor Cells in a Phase 3 Study of Docetaxel and Prednisone with or without Lenalidomide in Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2017 Feb;71(2):168-171. doi: 10.1016/j.eururo.2016.07.051. Epub 2016 Aug 10.

Reference Type: BACKGROUND

PMID: 27522164 (View on PubMed)

Petrylak DP, Vogelzang NJ, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, de Olza MO, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, Van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, de Wit R, Fizazi K. Docetaxel and prednisone with or without lenalidomide in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (MAINSAIL): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2015 Apr;16(4):417-25. doi: 10.1016/S1470-2045(15)70025-2. Epub 2015 Mar 3.

Reference Type: RESULT

PMID: 25743937 (View on PubMed)

de Morree ES, Vogelzang NJ, Petrylak DP, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, Ochoa de Olza M, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, Li JS, de Wit R. Association of Survival Benefit With Docetaxel in Prostate Cancer and Total Number of Cycles Administered: A Post Hoc Analysis of the Mainsail Study. JAMA Oncol. 2017 Jan 1;3(1):68-75. doi: 10.1001/jamaoncol.2016.3000.

Reference Type: RESULT

PMID: 27560549 (View on PubMed)

Other Identifiers

EudraCT Number 2008-007969-23

Identifier Type: -

Identifier Source: secondary_id

CC-5013-PC-002

Identifier Type: -

Identifier Source: org_study_id