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

March 9, 2018 updated by: Celgene

A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone With or Without Lenalidomide in Subjects With Castrate-Resistant Prostate Cancer (CRPC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1059

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Flinders Medical Centre
      • Camperdown, Australia, NSW 2050
        • Chris O'Brien Lifehouse
      • Nedlands, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Port Macquarie, Australia, NSW 2444
        • Port Macquarie Base Hospital
      • Redcliffe, Australia, QLD 4020
        • Redcliffe Hospital
      • St Leonards, Australia, 2065
        • Royal North Shore Hospital
      • Waratah, Australia, 2298
        • Newcastle Calvary Mater Hospital
      • Westmead, Australia, NSW 2145
        • Westmead Hospital
      • Wodonga, Australia, 3690
        • Border Medical Oncology
      • Woodville South, Australia, 5011
        • The Queen Elizabeth Hospital
      • Woolloongabba, Australia, QLD 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, SA 5000
        • Royal Adelaide Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz
      • Salzburg, Austria, 5020
        • Landeskrankenhaus Salzburg
      • Vienna, Austria, 1090
        • Medizinische Universitat Wien
      • Vienna, Austria, 1020
        • Krankenhaus Der Barmherzigen Brueder
  • Belgium
      • Antwerpen, Belgium, 2020
        • ZNA Middelheim
      • Brussels, Belgium, 1070
        • Hôpital Erasme
      • Bruxelles, Belgium, 1180
        • Edith Cavell Clinic
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Sint-Niklaas, Belgium, 9100
        • AZ Nikolaas
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M1P 2T7
        • The Health Institute for Men CMX Research Inc
    • Quebec
      • Montreal, Quebec, Canada, H2X 1N8
        • Les Urologues Specialises
  • Czechia
      • Chomutov, Czechia, 430 12
        • Krajska zdravotni, a.s. Nemocnice Chomutov, o.z.
      • Prague 5, Czechia, 150 06
        • Fakultni nemocnice Motol
      • Usti Nad Labem, Czechia, 40113
        • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La
  • Denmark
      • Aarhus C, Denmark, 8000
        • Århus Universitets Hospital
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Kobenhavn, Denmark, 2100
        • Rigshospitalet University Hospital
      • Odense C, Denmark, 5000
        • Odense Universitetshospital
  • France
      • Angers 49, France, 49933
        • CRLCC Paul Papin
      • Bordeaux, France, 33076
        • Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
      • Dijon Cedex, France, 21079
        • Centre Georges François Leclerc
      • Le Mans, France, 72000
        • Clinique Victor Hugo
      • Lille 59, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69373
        • Centre Leon Berard
      • Nimes, France, 30900
        • Clinique De Valdegour
      • Poitiers Cedex, France, 86021
        • Chu de Poitiers
      • Rennes Cedex, France, 35042
        • Centre Eugène Marquis
      • Saint Herblain 44, France, 44805
        • CRLCC Centre Rene Gauducheau
      • Saint Priest En Jaroz, France, 42270
        • Institut de Cancerologie de La Loire
      • Strasbourg, France, 67091
        • Hôpital Civil de Strasbourg
      • Tours Cedex, France, 37044
        • CHRU Hôpital Bretonneau
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, 10967
        • Vivantes Klinikum am Urban
      • Bonn, Germany, 53111
        • Medizinisches Zentrum Bonn-Friedensplatz
      • Dessau-Rosslau, Germany, 06846
        • Diakonissenkrankenhaus Dessau gGmbH
      • Duesseldorf, Germany, 40225
        • Universitaetsklinikum Duesseldorf
      • Frankfurt a.M., Germany, 60488
        • Krankenhaus Nordwest
      • Freiburg, Germany, 79106
        • Onkologische Praxis Freiburg
      • Hamburg, Germany, 20246
        • Universitatsklinikum Hamburg-Eppendorf / IVDP
      • Hamburg, Germany, 22081
        • IORC- Innovation Onkologie Research and Consulting GmbH
      • Koblenz, Germany, 56068
        • Praxis fuer Haematologie und Onkologie Koblenz
      • Leipzig, Germany, 4277
        • Vituro GmbH & Co KG
      • München, Germany, 81675
        • TU München - Klinikum rechts der Isar
      • Münster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Tuebingen, Germany, 72076
        • University-Hospital Tübingen
      • Ulm, Germany, 89075
        • Universitatsklinikum Ulm
  • Greece
      • Athens, Greece, 11528
        • Alexandra General Hospital of Athens
      • Athens, Greece, 14564
        • Agioi Anargyroi Hospital
      • Larissa, Greece, 41110
        • University Hospital of Larissa
      • Thessaloniki, Greece, 56429
        • Papageorgiou General Hospital of Thessaloniki
  • Hungary
      • Budapest, Hungary, 1076
        • Fovarosi Onkirmanyzat Peterfy S.Utcai Korhaz-Rend.Int es Baleseti Kozp.
      • Budapest, Hungary, 1106
        • Fovarosi Onkormanyzat Bajcsy-Zsilinszky Korhaz es Rendelointezet
      • Miskolc, Hungary, 3526
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
      • Pecs, Hungary, 7623
        • Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar
  • Israel
      • Beer Sheva, Israel, 84101
        • The Soroka University Medical Center
      • Haifa, Israel, 31096
        • Rambam Health Care Campus
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center
  • Italy
      • Bari, Italy, 70124
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
      • Candiolo, Italy, 10023
        • Ordine Mauriziano
      • Cremona, Italy, 23100
        • Azienda Ospedaliera Istituti Ospitalieri di Cremona
      • Lecce, Italy, 73100
        • Ospedale Vito Fazzi
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
      • Mirano (VE), Italy, 30035
        • Ospedale di Mirano
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Rimini, Italy, 47900
        • Ospedale degli Infermi di Rimini
      • Roma, Italy, 00149
        • Azienda Ospedaliera San Camillo Forlanini
      • Udine, Italy, 70124
        • Azienda Ospedaliero-Universitaria Santa Maria della Miserico
  • Mexico
      • D.f, Df, Mexico, 07760
        • Hospital Angeles Lindavista
      • Durango, DGO, Mexico, 34000
        • Consultorio de Especialidad en Urologia Privado
      • Sinaloa, SIN, Mexico, 81200
        • Hospital Fatima
      • Zapopan, JAL, Mexico, 45040
        • Consultorio Privado- Dr Jose Arturo Rodriguez Rivera
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU University Medical Center VU Medisch Centrum
      • Arhem, Netherlands, 6800 TA
        • Ziekenhuis Rijnstate
      • Breda, Netherlands, 4818 CK
        • Amphia Ziekenhuis Molengracht
      • Den Haag, Netherlands, 2545 CH
        • HagaZiekenhuis
      • Den Helder, Netherlands, 1782 GZ
        • Gemini Ziekenhuis
      • Dordrecht, Netherlands, 3317 NM
        • Albert Schweitzer Ziekenhuis Amstelwijck
      • Eindhoven, Netherlands, 5632 EJ
        • Catharina Ziekenhuis
      • Leeuwarden, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden
      • Leiden, Netherlands, 2333 ZA
        • Leids Universitair Medisch Centrum
      • Maastricht, Netherlands, 6229 HX
        • Academisch Ziekenhuis Maastricht
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis Nieuwegein
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medisch Centrum
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medical Center
      • Tilburg, Netherlands, 5042 AD
        • Twee Steden Ziekenhuis Tilburg
      • Venlo, Netherlands, 5912 BL
        • VieCuri Medisch Centrum Venlo
      • Zwolle, Netherlands, 8025 AB
        • Isala Klinieken
  • Poland
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Lodz, Poland, 93-509
        • Regionalny Osrodek Onkologiczny WSS im. M. Kopernika
      • Olsztyn, Poland, 10-228
        • ZOZ MSWiA z Warminsko- Mazurskim Centrum Onkologii
      • Olsztyn, Poland, 10-513
        • NZOZ Olsztynski Osr. Onkologiczny Kopernik Sp.z o.o
      • Rybnik, Poland, 44-200
        • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
      • Warszawa, Poland, 02-781
        • Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
      • Wroclaw, Poland, 50-981
        • 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
  • Russian Federation
      • Moscow, Russian Federation, 105005
        • Moscow Oncology Clinical Dispensary 1
      • Obninsk, Russian Federation, 249036
        • Medical Radiology Research Centre RAMS
      • Omsk, Russian Federation, 644013
        • State Institution of Heath Omsk Regional Oncology Dispensary
      • Pesochny Vlg Saint Petersburg, Russian Federation, 197758
        • Russian Scientific Center for Radiology and Surgical Technol, St. Petersburg
      • Rostov-on-Don, Russian Federation, 344011
        • NSHI Dorozhnaya Clinical Hospital of OAO Russian Railways
      • Sochi, Russian Federation, 354057
        • Oncology Dispensary 2 of Krasnodar Region
      • Yaroslavl, Russian Federation, 150054
        • Yaroslavl Regional Clinical Oncology Hospital
  • South Africa
      • Cape Town, W Cape, South Africa, 7925
        • Groote Schuur Hospital
      • Durban, KZ-Natal, South Africa, 4091
        • The Oncology Centre Durban
      • Durban, KZ-Natal, South Africa, 4091
        • Westridge Medical Centre
      • Goodwood, W Cape, South Africa, 7460
        • Netcare Oncology and Interventional Centre
      • Polokwane, South Africa, 699
        • Dr. H. Malan
      • Pretoria, South Africa, 0083
        • Pretoria Urology Hospital
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO
      • Lérida, Spain, 25198
        • Hospital Arnau de Vilanova
      • Madrid, Spain, 28041
        • Hospital 12 de Octobre
      • Malaga, Spain, 29010
        • HCU Virgen de la Victoria
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra
      • Terrassa (Barcelona), Spain, 08221
        • Hospital Mútua de Terrassa
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
  • Sweden
      • Jönköping, Sweden, 55185
        • Länssjukhuset Ryhov
      • Umeå, Sweden, 90185
        • Norrlands Universitetssjukhus
      • Västerås, Sweden, 721 89
        • Centrallasarettet Vasteras
  • United Kingdom
      • Bebington, Wirral, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
      • London, United Kingdom, SW17 0QT
        • St George's Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas' Hospital - London
      • Manchester, United Kingdom, M20 4BX
        • Christie NHS Trust Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Scunthorpe, United Kingdom, DN15 7BH
        • Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Hematology Oncology Associates
      • Sedona, Arizona, United States, 86336
        • Northern AZ Hematology and Oncology Assoc
      • Tucson, Arizona, United States, 85710
        • Arizona Oncology
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Cancer Center
      • Escondido, California, United States, 92025
        • Southwest Cancer Center - Escondido
      • La Jolla, California, United States, 92037
        • Scripps Cancer Center - Clinical Research
      • Long Beach, California, United States, 90822
        • VA Long Beach Healthcare System
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90025
        • The Angeles Clinc and Research Institute
      • Marina Del Rey, California, United States, 90292
        • Prostate Oncology Specialists
      • Stanford, California, United States, 94035-5821
        • Stanford University Medical Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Rocky Mountain Cancer Centers-Colorado Springs Circle
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute
    • Florida
      • Melbourne, Florida, United States, 32901
        • Melbourne Internal Medicine Associates
      • Miami, Florida, United States, 33176
        • Advanced Medical Specialties
      • New Port Richey, Florida, United States, 34655
        • Florida Cancer Institute - New Hope
      • Ocala, Florida, United States, 34474
        • Ocala Oncology Center
      • Orlando, Florida, United States, 32806
        • Cancer Centers of Florida, P.A.- West Gore Street
      • Tamarac, Florida, United States, 33321
        • South Florida Oncology - Hematology
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Cancer Institute, LLC
    • Illinois
      • Niles, Illinois, United States, 60714
        • Cancer Care and Hematology Specialists of Chicagoland
      • Park Ridge, Illinois, United States, 60068
        • Lutheran General Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46219
        • Indiana University Health
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Hematology and Oncology Specialist, LLC
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology PA
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology, PA
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Cancer Associates
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Berkeley Heights, New Jersey, United States, 07922
        • Summit Medical Group Overlook Oncology Center
      • Morristown, New Jersey, United States, 07960
        • Hematology-Oncology Associates of NNJ, P
      • Mount Holly, New Jersey, United States, 08060
        • Hematology Oncology Associates of South Jersey
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology P.C.
      • New York, New York, United States, 10032
        • Columbia Univ Medical Center
      • New York, New York, United States, 10065
        • Weill Cornell Medical College Dr. Feldman's Office
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • New Bern Cancer Care
      • Raleigh, North Carolina, United States, 27607
        • Cancer Centers of North Carolina
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic, PC
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care, Inc.
    • Oregon
      • Tualatin, Oregon, United States, 97062
        • Northwest Cancer Specialists-Tualatin
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Ralph H. Johnson VA Medical Center
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Associates, PA
      • Greer, South Carolina, United States, 29650
        • Cancer Center Of The Carolinas
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Oncology Hematology Associates
      • Cookeville, Tennessee, United States, 38501
        • Cookeville Regional Medical Center
      • Nashville, Tennessee, United States, 37203-1632
        • Sarah Cannon Research Institute UK
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology, P.A.-Amarillo
      • Arlington, Texas, United States, 76014
        • Texas Oncology-Arlington South
      • Austin, Texas, United States, 78758
        • Texas Oncology, PA
      • Dallas, Texas, United States, 75246
        • Baylor Sammons Cancer Center
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology, P.A.-Fort Worth
      • Longview, Texas, United States, 75601
        • Longview Cancer Center
      • Midland, Texas, United States, 79701
        • Allison Cancer Center
      • Paris, Texas, United States, 75460
        • Texas Oncology, P.A. - Paris
      • Southlake, Texas, United States, 76092
        • Southlake Oncology
      • Tyler, Texas, United States, 75702
        • Texas Oncology, P.A. - Tyler
      • Webster, Texas, United States, 77598
        • Texas Oncology Deke Slayton Cancer Center
      • Wichita Falls, Texas, United States, 76310
        • Texas Oncology-Texoma Cancer Center
    • Vermont
      • White River Junction, Vermont, United States, 05009
        • Veterans Education and Research Association of Northern New England, Inc.
    • Virginia
      • Abingdon, Virginia, United States, 24211
        • Cancer Outreach Associates
      • Fairfax, Virginia, United States, 22031
        • Fairfax Northern Virginia Hematology Oncology
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Inc.
    • Washington
      • Kennewick, Washington, United States, 99336
        • Columbia Basin Hematology and Oncology
      • Seattle, Washington, United States, 98108-1532
        • VA Puget Sound HCS Seattle Division
      • Spokane, Washington, United States, 99218
        • Evergreen Hematology and Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Lenalidomide
25 mg lenalidomide orally once each day on Days 1-14
Other Names:
  • CC-5013
  • Revlimid
Drug: Docetaxel
75 mg/m2 intravenous docetaxel on Day 1
Other Names:
  • Taxotere
Drug: Prednisone
5 mg prednisone orally twice daily on each day of the treatment cycle
Other Names:
  • There are multiple brand names for prednisone.
Experimental: 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
Drug: Docetaxel
75 mg/m2 intravenous docetaxel on Day 1
Other Names:
  • Taxotere
Drug: Prednisone
5 mg prednisone orally twice daily on each day of the treatment cycle
Other Names:
  • There are multiple brand names for prednisone.
Drug: Placebo
Oral placebo once each day on Days 1-14 of the treatment cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months
Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley.
From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From randomization until disease progression or death from any cause; up to the cut-off date of 13 Jan 2012; maximum time on study was approximately 26 months
PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan
From randomization until disease progression or death from any cause; up to the cut-off date of 13 Jan 2012; maximum time on study was approximately 26 months
Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria
Time Frame: From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months
Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response based on RECIST Criteria 1.1 and defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to <10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones
From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months
Number of Participants With Treatment Emergent Adverse Events (AEs)
Time Frame: From the time from of first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut off date of 13 January 2012; the maximum duration of study drug was 93 weeks for DP and 90.6 weeks for DPL
A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;
From the time from of first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut off date of 13 January 2012; the maximum duration of study drug was 93 weeks for DP and 90.6 weeks for DPL
Percentage of Participants Who Received Post-Study Therapies
Time Frame: The date when the first consent form was signed to the last date of AE data collection;up to 5 years; up to the date of the final data analysis date of 20 April 2017
Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer.
The date when the first consent form was signed to the last date of AE data collection;up to 5 years; up to the date of the final data analysis date of 20 April 2017
Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial
Time Frame: The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days
Second primary malignancies were monitored as events of interest and reported as serious adverse events throughout the course of the trial.
The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days
Time to Onset of Secondary Primary Malignancies
Time Frame: The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days
Time of Onset of Secondary Primary Malignancies was considered an event of interest
The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Debora Barton, MD, Celgene Corporation

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2009

Primary Completion (Actual)

January 13, 2012

Study Completion (Actual)

November 28, 2016

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (Estimate)

October 2, 2009

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

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Other Study ID Numbers

  • CC-5013-PC-002
  • EudraCT Number 2008-007969-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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