Back to resultsA Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sorafenib (Nexavar, BAY43-9006)
Carboplatin/Paclitaxel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sorafenib (Nexavar, BAY43-9006)
Carboplatin/Paclitaxel (C/P)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
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.
Secondary Outcome Measures
Overall Survival (OS)
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 to Progression (TTP)
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.
Duration of Response (DOR)
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.
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noted
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00111007
Brief Title
A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sorafenib (Nexavar, BAY43-9006)
Arm Type
Experimental
Arm Description
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.
Arm Title
Carboplatin/Paclitaxel (C/P)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sorafenib (Nexavar, BAY43-9006)
Intervention Description
Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19
Intervention Type
Drug
Intervention Name(s)
Carboplatin/Paclitaxel
Intervention Description
Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, 2 tablets bid Study Days 2-19
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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 Frame
Time from randomization to documented tumor progression or death (median time of 124 days)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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 Frame
Time from randomization to death (median time of 294 days)
Title
Time to Progression (TTP)
Description
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 Frame
Time from randomization to documented tumor progression (median time of 126 days)
Title
Duration of Response (DOR)
Description
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 Frame
Time from initial response to documented tumor progression or death (median time of 197 days)
Title
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noted
Description
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).
Time Frame
baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
City
Warartah
State/Province
New South Wales
ZIP/Postal Code
2300
Country
Australia
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Bordeaux
ZIP/Postal Code
33000
Country
France
City
Boulogne-billancourt
ZIP/Postal Code
92104
Country
France
City
Brest
ZIP/Postal Code
29285
Country
France
City
Lyon Cedex
ZIP/Postal Code
39373
Country
France
City
Montpellier Cedex
ZIP/Postal Code
34298
Country
France
City
Paris
ZIP/Postal Code
75010
Country
France
City
Paris
ZIP/Postal Code
75634
Country
France
City
Villejuif
ZIP/Postal Code
94805
Country
France
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69112
Country
Germany
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68135
Country
Germany
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60488
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54290
Country
Germany
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
City
Bebington
State/Province
Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19349552
Citation
Hauschild A, Agarwala SS, Trefzer U, Hogg D, Robert C, Hersey P, Eggermont A, Grabbe S, Gonzalez R, Gille J, Peschel C, Schadendorf D, Garbe C, O'Day S, Daud A, White JM, Xia C, Patel K, Kirkwood JM, Keilholz U. Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma. J Clin Oncol. 2009 Jun 10;27(17):2823-30. doi: 10.1200/JCO.2007.15.7636. Epub 2009 Apr 6.
Results Reference
result
Links:
URL
http://www.clinicaltrialsregister.eu
Description
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Learn more about this trial
A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma
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