Clinical trial NCT00110994: Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma
Official title: Phase II Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Dacarbazine (DTIC) Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Melanoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2005-05-17
Enrollment: 101
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: This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be randomized to receive DTIC + Sorafenib or DTIC + Placebo.


Eligibility criteria: Inclusion Criteria:

* Patients who have a life expectancy of at least 12 weeks
* Patients with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
* Patients 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 \< 3 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 (the maximum treatment duration of 71.1 weeks)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Time from randomization to death (the maximum treatment duration of 71.1 weeks)
measure: Number of Participants in Tumor Response Categories
timeFrame: Every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
measure: Time to Progression (TTP)
timeFrame: Time from randomization to documented tumor progression (median time of 148 days)
measure: Duration of Response (DOR)
timeFrame: Time from initial response to documented tumor progression or death (median time of 188 days)
measure: Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted
timeFrame: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
measure: Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the Visit at Which Best Response Was First Noted
timeFrame: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
measure: Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment
timeFrame: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
measure: Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted
timeFrame: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
measure: Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment
timeFrame: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Aurora
country: United States
state: Colorado
city: Lakeland
country: United States
state: Florida
city: Park Ridge
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Charlotte
country: United States
state: North Carolina
city: Pittsburgh
country: United States
state: Pennsylvania
city: Hilton Head Island
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: McDermott DF, Sosman JA, Gonzalez R, Hodi FS, Linette GP, Richards J, Jakub JW, Beeram M, Tarantolo S, Agarwala S, Frenette G, Puzanov I, Cranmer L, Lewis K, Kirkwood J, White JM, Xia C, Patel K, Hersh E. Double-blind randomized phase II study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: a report from the 11715 Study Group. J Clin Oncol. 2008 May 1;26(13):2178-85. doi: 10.1200/JCO.2007.14.8288.