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

Sponsors and Collaborators:	Weill Medical College of Cornell University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00119249

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition	Intervention	Phase
Melanoma (Skin)	Drug: sorafenib tosylate	Phase II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of BAY 43-9006 (NSC 724772) in Unresectable Stage III and Stage IV Melanoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate (partial or complete response) as measured by RECIST criteria after the second course [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to progression [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Changes in BRAF, P-MAPK, CDK4, and cyclin D1 levels at baseline and after completion of study treatment [ Designated as safety issue: No ]

Estimated Enrollment:	74
Study Start Date:	June 2005
Estimated Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

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

Correlate the efficacy of this drug with the presence of mutant or wild-type BRAF gene in tumors of these patients.
Determine the toxicity profile of this drug in these patients.
Correlate serum cryptic collagen epitopes with the extent of tumor burden, invasion, and metastasis in patients treated with this drug.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2 OR
Karnofsky 60-100%

Life expectancy

At least 3 months

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
No evidence of bleeding diathesis

Hepatic

AST and ALT ≤ 2.5 times upper limit of normal (ULN)
Bilirubin ≤ 2 times ULN

Renal

Creatinine ≤ 1.5 times ULN

Cardiovascular

No uncontrolled hypertension
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

Other

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-hematolgical 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior systemic chemotherapy for metastatic disease

Endocrine therapy

See Disease Characteristics

Radiotherapy

See Disease Characteristics

Surgery

Not specified

Other

No other concurrent investigational agents
No concurrent therapeutic anticoagulation
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent anticancer therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119249

Locations

United States, New York
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Australia, New South Wales
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050

Sponsors and Collaborators

Weill Medical College of Cornell University

National Cancer Institute (NCI)

Investigators

Study Chair:

Anna Pavlick, MD

New York University School of Medicine

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Study ID Numbers:	CDR0000434613, NYWCCC-NYU-0438, NCI-6617
Study First Received:	July 12, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00119249
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

stage III melanoma
stage IV melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Sorafenib
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Neoplasms, Nerve Tissue
Enzyme Inhibitors
Nevi and Melanomas
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009