Clinical trial NCT00111007: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2005-05-17
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Time from randomization to documented tumor progression or death (median time of 124 days)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Time from randomization to death (median time of 294 days)
measure: Time to Progression (TTP)
timeFrame: Time from randomization to documented tumor progression (median time of 126 days)
measure: Duration of Response (DOR)
timeFrame: Time from initial response to documented tumor progression or death (median time of 197 days)
measure: Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noted
timeFrame: baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Montclair
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Camperdown
country: Australia
state: New South Wales
city: Warartah
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: East Melbourne
country: Australia
state: Victoria
city: Heidelberg
country: Australia
state: Victoria
city: Malvern
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Bordeaux
country: France
city: Boulogne-billancourt
country: France
city: Brest
country: France
city: Lyon Cedex
country: France
city: Montpellier Cedex
country: France
city: Paris
country: France
city: Paris
country: France
city: Villejuif
country: France
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Mannheim
country: Germany
state: Baden-Württemberg
city: Tübingen
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Trier
country: Germany
state: Rheinland-Pfalz
city: Homburg
country: Germany
state: Saarland
city: Kiel
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Amsterdam
country: Netherlands
city: Rotterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Southampton
country: United Kingdom
state: Hampshire
city: Leicester
country: United Kingdom
state: Leicestershire
city: Bebington
country: United Kingdom
state: Merseyside
city: Nottingham
country: United Kingdom
state: Nottinghamshire
city: Sutton
country: United Kingdom
state: Surrey
city: Leeds
country: United Kingdom
state: West Yorkshire
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Swansea
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.