check_circleStudy Completed

Melanoma

Bayer Identifier:

11718

ClinicalTrials.gov Identifier:

NCT00111007

EudraCT Number:

2005-000941-12

EU CT Number:

Not Available
A Treatment Combination for Patients with Unresectable Stage III or Stage IV Melanoma

Trial purpose

The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Subjects who have a life expectancy of at least 12 weeks
    - Subjects with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
    - Subjects must have progressed after receiving at least one cycle of DTIC or TMZ containing regimen
    - Subjects who have an ECOG PS of 0 or 1
    - Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria
  • - Primary ocular or mucosal melanoma
    - Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"]& T1 [Tumor invades subepithelial connective tissue]) or any cancer curatively treated < 5 years prior to study entry
    - History of cardiac disease
    - Known history of human immunodeficiency virus (HIV) infection

Trial summary

Enrollment Goal
270
Trial Dates
May 2005 - January 2009
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
Klinikum der Christian-Albrechts-UniversitätKiel, 24105, Germany
Completed
Krankenhaus NordwestFrankfurt, 60488, Germany
Completed
Klinikum Mannheim gGmbHMannheim, 68135, Germany
Completed
Royal Marsden Hospital (London)London, SW3 6JJ, United Kingdom
Terminated
Guy's HospitalLondon, SE1 9RT, United Kingdom
Completed
Christie HospitalManchester, M20 4BX, United Kingdom
Terminated
Clatterbridge Centre for OncologyBebington, CH63 4JY, United Kingdom
Completed
Southampton General HospitalSouthampton, SO16 6YD, United Kingdom
Completed
Nottingham City HospitalNottingham, NG5 1PB, United Kingdom
Completed
Singleton HospitalSwansea, SA2 8QA, United Kingdom
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Completed
University of Pittsburgh Medical Center Health SystemPittsburgh, 15232, United States
Completed
University of Arizona Cancer CenterTucson, 85724, United States
Completed
Nebraska Methodist HospitalOmaha, 68114, United States
Completed
Office of Dr. Sewa Legha, MDHouston, 77030, United States
Terminated
University of Alabama at BirminghamBirmingham, 35243, United States
Completed
University of Virginia Health SystemCharlottesville, 22908, United States
Completed
Washington University School of MedicineSt. Louis, 63110, United States
Completed
University of LouisvilleLouisville, 40202, United States
Terminated
Rush University Medical CenterChicago, 60612, United States
Completed
Mountainside HospitalMontclair, 07042, United States
Terminated
Oncology Specialists, SCPark Ridge, 60068, United States
Terminated
Advocate Lutheran General HospitalPark Ridge, 60068, United States
Completed
Hôpital Ambroise Paré - Boulogne BillancourtBOULOGNE-BILLANCOURT, 92104, France
Completed
Institut Gustave Roussy - VillejuifVILLEJUIF, 94805, France
Terminated
Hôpital de la Pitié-Salpétrière - ParisPARIS, 75634, France
Terminated
Krankenanstalt Mutterhaus der BorromaerinnenTrier, 54290, Germany
Completed
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60590, Germany
Completed
Universitätsklinikum EssenEssen, 45122, Germany
Completed
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69112, Germany
Completed
Klinikum rechts der IsarMünchen, 81675, Germany
Completed
Universitätsklinikum des SaarlandesHomburg, 66421, Germany
Completed
Leicester Royal InfirmaryLeicester, LE1 5WW, United Kingdom
Completed
St James' University HospitalLeeds, LS9 7TF, United Kingdom
Completed
Vanderbilt University Medical SchoolNashville, 37232-6307, United States
Completed
Memorial Sloan-Kettering Cancer CenterNew York, 10065, United States
Completed
The Angeles Clinic & Research InstituteLos Angeles, 90025, United States
Completed
James Care - Kenny RoadColumbus, 43221, United States
Completed
Hôpital Saint André - BordeauxBORDEAUX, 33000, France
Completed
Sir Mortimer B. Davis Jewish General HospitalMontreal, H3T 1E2, Canada
Completed
Erasmus MC Daniel den HoedROTTERDAM, 3075 EA, Netherlands
Completed
Nederlands Kanker InstituutAMSTERDAM, 1066 CX, Netherlands
Completed
Cabrini Medical CentreMalvern, 3144, Australia
Terminated
Royal Prince Alfred HospitalCamperdown, 2050, Australia
Completed
The Alfred HospitalMelbourne, 3004, Australia
Completed
Newcastle Mater Misericordiae HospitalWarartah, 2300, Australia
Terminated
Sir Charles Gairdner HospitalNedlands, 6009, Australia
Completed
University of South FloridaTampa, 33612, United States
Completed
University of Colorado Health Sciences CenterAurora, 80045, United States
Completed
Seattle Cancer Care AllianceSeattle, 98109-1023, United States
Completed
Roswell Park Cancer InstituteBuffalo, 14263, United States
Terminated
Centre Val d'Aurelle - MontpellierMONTPELLIER CEDEX, 34298, France
Completed
Hôpital Saint Louis - ParisPARIS, 75010, France
Completed
Hôpital Morvan - BrestBREST, 29285, France
Completed
Centre Léon BérardLYON CEDEX, 39373, France
Completed
Cross Cancer InstituteEdmonton, T6G 1Z2, Canada
Completed
Princess Margaret Hospital-University Health NetworkToronto, M5G 2M9, Canada
Completed
London Regional Cancer ProgramLondon, N6A 4L6, Canada
Completed
Tom Baker Cancer CentreCalgary, T2N 4N2, Canada
Completed
Sunnybrook Health Sciences CentreToronto, M4N 3M5, Canada
Terminated
University Medical Center UtrechtUTRECHT, 3584 CX, Netherlands
Completed
Austin HealthHeidelberg, 3084, Australia
Completed
Westmead HospitalWestmead, 2145, Australia
Completed
Brisbane Mater Misericordiae HospitalBrisbane, 4101, Australia
Completed
Peter MacCallum Cancer InstituteEast Melbourne, 3002, Australia

Primary Outcome

  • Progression Free Survival (PFS)
    date_rangeTime Frame:
    Time from randomization to documented tumor progression or death (median time of 124 days)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall Survival (OS)
    date_rangeTime Frame:
    Time from randomization to death (median time of 294 days)
    enhanced_encryption
    Safety Issue:
    No
  • Time to Progression (TTP)
    date_rangeTime Frame:
    Time from randomization to documented tumor progression (median time of 126 days)
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Response (DOR)
    date_rangeTime Frame:
    Time from initial response to documented tumor progression or death (median time of 197 days)
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noted
    date_rangeTime Frame:
    baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)
    enhanced_encryption
    Safety Issue:
    No

Trial design

Phase III Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination with Paclitaxel/Carboplatin Chemotherapy in Subjects with Unresectable Stage III or Stage IV Melanoma.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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