A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma

October 23, 2014 updated by: Bayer

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

270

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
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Warartah, New South Wales, Australia, 2300
      • Westmead, New South Wales, Australia, 2145
    • Queensland
      • Brisbane, Queensland, Australia, 4101
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
      • Heidelberg, Victoria, Australia, 3084
      • Malvern, Victoria, Australia, 3144
      • Melbourne, Victoria, Australia, 3004
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
      • Edmonton, Alberta, Canada, T6G 1Z2
    • Ontario
      • London, Ontario, Canada, N6A 4L6
      • Toronto, Ontario, Canada, M5G 2M9
      • Toronto, Ontario, Canada, M4N 3M5
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
  • France
      • Bordeaux, France, 33000
      • Boulogne-billancourt, France, 92104
      • Brest, France, 29285
      • Lyon Cedex, France, 39373
      • Montpellier Cedex, France, 34298
      • Paris, France, 75010
      • Paris, France, 75634
      • Villejuif, France, 94805
  • Germany
      • Berlin, Germany, 12200
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69112
      • Mannheim, Baden-Württemberg, Germany, 68135
      • Tübingen, Baden-Württemberg, Germany, 72076
    • Bayern
      • München, Bayern, Germany, 81675
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
      • Frankfurt, Hessen, Germany, 60488
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45122
    • Rheinland-Pfalz
      • Trier, Rheinland-Pfalz, Germany, 54290
    • Saarland
      • Homburg, Saarland, Germany, 66421
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
      • Rotterdam, Netherlands, 3075 EA
      • Utrecht, Netherlands, 3584 CX
  • United Kingdom
      • London, United Kingdom, SE1 9RT
      • London, United Kingdom, SW3 6JJ
      • Manchester, United Kingdom, M20 4BX
      • Swansea, United Kingdom, SA2 8QA
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
    • Merseyside
      • Bebington, Merseyside, United Kingdom, CH63 4JY
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
    • Arizona
      • Tucson, Arizona, United States, 85724
    • California
      • Los Angeles, California, United States, 90025
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Tampa, Florida, United States, 33612
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Park Ridge, Illinois, United States, 60068
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • New Jersey
      • Montclair, New Jersey, United States, 07042
    • New York
      • Buffalo, New York, United States, 14263
      • New York, New York, United States, 10065
    • Ohio
      • Columbus, Ohio, United States, 43221
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6307
    • Texas
      • Houston, Texas, United States, 77030
    • Virginia
      • Charlottesville, Virginia, United States, 22908
    • Washington
      • Seattle, Washington, United States, 98109-1023

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

All

Description

Inclusion Criteria:

  • 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

Exclusion 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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib (Nexavar, BAY43-9006)
Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19
Drug: Carboplatin/Paclitaxel
Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1
Active Comparator: Carboplatin/Paclitaxel (C/P)
Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
Drug: Carboplatin/Paclitaxel
Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1
Drug: Placebo
Placebo, 2 tablets bid Study Days 2-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Time from randomization to documented tumor progression or death (median time of 124 days)
PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors [RECIST] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.
Time from randomization to documented tumor progression or death (median time of 124 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Time from randomization to death (median time of 294 days)
Overall survival (OS) was calculated as the number of days from date of randomization to death date. Subjects who had not died at the time of analysis were censored at their last contact date.
Time from randomization to death (median time of 294 days)
Time to Progression (TTP)
Time Frame: Time from randomization to documented tumor progression (median time of 126 days)
TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (DP) (per modified RECIST or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease). The actual dates of tumor assessments were used for this calculation. TTP for subjects without disease progression at the time of analysis, including subjects with death prior to progression, was censored at the last date of tumor evaluation. TTP for subjects who had no tumor assessments after baseline was censored at 1 day.
Time from randomization to documented tumor progression (median time of 126 days)
Duration of Response (DOR)
Time Frame: Time from initial response to documented tumor progression or death (median time of 197 days)
Duration of response was defined as the time from the first documented objective response of Partial Response (PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD or better) or Complete Response (CR: Disappearance of all target lesions), whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment.
Time from initial response to documented tumor progression or death (median time of 197 days)
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noted
Time Frame: baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)
Change in ECOG PS is defined as an improvement (increase) or worsening (decrease) of at least one grade from the baseline ECOG score (from 0 [fully active] to 5 [dead]). Change in ECOG PS was recorded at the visit at which best confirmed response (BCR) using the modified RECIST (PR, CR, stable disease or Progressive Disease (PD)) was first noted (the change was 7% for both Sorafenib and Placebo). The BCR is the BCR recorded from the start of the treatment until DP/recurrence (taking as reference for DP, the smallest measurements recorded since treatment started).
baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)

Collaborators and Investigators

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

Sponsor

Bayer

Collaborators

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

May 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

May 16, 2005

First Submitted That Met QC Criteria

May 16, 2005

First Posted (Estimate)

May 17, 2005

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11718
  • 2005-000941-12 (EudraCT Number)

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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