Expired Study
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Bronx, New York 10467


Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well sorafenib works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery

Study summary:

PRIMARY OBJECTIVES: I. Determine the efficacy of sorafenib, in terms of anti-tumor effects and proportion of clinical responses, in patients with previously untreated unresectable stage III or stage IV melanoma. SECONDARY OBJECTIVES: I. Correlate the efficacy of this drug with the presence of mutant or wild-type BRAF gene in tumors of these patients. II. Determine the toxicity profile of this drug in these patients. III. Correlate serum cryptic collagen epitopes with the extent of tumor burden, invasion, and metastasis in patients treated with this drug. IV. Determine the potential of serum cryptic collagen epitopes to serve as a surrogate marker for monitoring the course of disease in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to presence of BRAF gene mutation in tumor sample (yes vs no). Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed annually. PROJECTED ACCRUAL: A total of 26-74 patients (13-37 per stratum) will be accrued for this study within 5.2-18.5 months.


Inclusion Criteria: - Histologically or cytologically confirmed unresectable melanoma - Stage III or IV disease - Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques OR > 10 mm by spiral CT scan - Disease amenable to biopsy (first 13 patients in each stratum only) - Brain metastases allowed provided the following criteria are met: - Disease has remained radiologically stable for ≥ 6 weeks after completion of whole-brain radiotherapy and remains stable at the time of study entry - No mass effect present by radiology - No requirement for steroid therapy to control symptoms of brain metastases - Performance status - ECOG 0-2 - Performance status - Karnofsky 60-100% - At least 3 months - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - No evidence of bleeding diathesis - AST and ALT ≤ 2.5 times upper limit of normal (ULN) - Bilirubin ≤ 2 times ULN - Creatinine ≤ 1.5 times ULN - No uncontrolled hypertension - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No psychiatric illness that would preclude study compliance - No pre-existing non-hematological dysfunction ≥ grade 2 - No ongoing or active infection - No history of serious allergic reaction to eggs - Able to swallow pills - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or other non-invasive carcinoma - No other uncontrolled illness - Not specified - No prior systemic chemotherapy for metastatic disease - See Disease Characteristics - See Disease Characteristics - No other concurrent investigational agents - No concurrent therapeutic anticoagulation - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent anticancer therapy

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

Sorafenib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Official Title:

A Phase II Study of BAY 43-9006 (NSC 724772) in Unresectable Stage III and IV Melanoma (IND 69,869)

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Endpoint Classification: Efficacy Study, Interven

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Anna Pavlick
Principal Investigator
Montefiore Medical Center

Study Dates

Start Date:June 2005
Primary Completion Date:November 2007
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 14, 2013
First Received Date:July 12, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Overall survival
Time Frame:Up to 3.5 years
Safety Issues:False
Description:Kaplan-Meier estimates will be calculated for time to progression and overall survival, and medians, along with two-sided 95% confidence intervals, will be reported.
Outcome Type:Secondary Outcome
Measure:Changes in BRAF, P-MAPK, CDK4, and cyclin D1 levels
Time Frame:Baseline and up to 3.5 years
Safety Issues:False
Description:The proportion of patients with decreases in levels of BRAF, CDK4, or phospho-MAPK will be estimated along with 95% confidence intervals.
Outcome Type:Secondary Outcome
Measure:Toxicity assessed using NCI CTCAE version 3.0
Time Frame:Up to 3.5 years
Safety Issues:True
Description:All adverse events without regard to causal relationship and by causal relationship to study drugs will be summarized.
Outcome Type:Secondary Outcome
Measure:Time to progression
Time Frame:From the first day of treatment until the first documentation of disease progression, assessed up to
Safety Issues:False
Description:Kaplan-Meier estimates will be calculated for time to progression and overall survival, and medians, along with two-sided 95% confidence intervals, will be reported.
Outcome Type:Primary Outcome
Measure:Response rate (RR) defined as is either a complete or a partial response using RECIST criteria
Time Frame:56 days
Safety Issues:False
Description:The overall response rate along with subgroup-specific response rates will be estimated at the end of the trial along with 95% confidence interval.

Study Interventions

Intervention Type:Drug
Name:sorafenib tosylate
Description:Given orally
Arm Name:Treatment (sorafenib tosylate)
Other Name:BAY 43-9006
Intervention Type:Other
Name:laboratory biomarker analysis
Description:Correlative studies
Arm Name:Treatment (sorafenib tosylate)

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment (sorafenib tosylate)
Description:Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Ott PA, Hamilton A, Min C, Safarzadeh-Amiri S, Goldberg L, Yoon J, Yee H, Buckley M, Christos PJ, Wright JJ, Polsky D, Osman I, Liebes L, Pavlick AC. A phase II trial of sorafenib in metastatic melanoma with tissue correlates. PLoS One. 2010 Dec 29;5(12):e15588.
Reference Type:Results Reference
Citation:Min C, Liebes L, Brooks P, et al.: Phase II trial of BAY 43-9006 (sorafenib-BAY) in metastatic melanoma (MM) including detection of BRAF mutations with mutant specific-PCR (MS-PCR) and altered proliferation pathways. [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-B254, 2007.

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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