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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00119249
First received: July 12, 2005
Last updated: January 14, 2013
Last verified: January 2013

July 12, 2005
January 14, 2013
June 2005
November 2007   (final data collection date for primary outcome measure)
Response rate (RR) defined as is either a complete or a partial response using RECIST criteria [ Time Frame: 56 days ] [ Designated as safety issue: No ]
The overall response rate along with subgroup-specific response rates will be estimated at the end of the trial along with 95% confidence interval.
Not Provided
Complete list of historical versions of study NCT00119249 on ClinicalTrials.gov Archive Site
  • Time to progression [ Time Frame: From the first day of treatment until the first documentation of disease progression, assessed up to 3.5 years ] [ Designated as safety issue: No ]
    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.
  • Toxicity assessed using NCI CTCAE version 3.0 [ Time Frame: Up to 3.5 years ] [ Designated as safety issue: Yes ]
    All adverse events without regard to causal relationship and by causal relationship to study drugs will be summarized.
  • Changes in BRAF, P-MAPK, CDK4, and cyclin D1 levels [ Time Frame: Baseline and up to 3.5 years ] [ Designated as safety issue: No ]
    The proportion of patients with decreases in levels of BRAF, CDK4, or phospho-MAPK will be estimated along with 95% confidence intervals.
  • Overall survival [ Time Frame: Up to 3.5 years ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
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Sorafenib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
A Phase II Study of BAY 43-9006 (NSC 724772) in Unresectable Stage III and IV Melanoma (IND 69,869)

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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stage III Melanoma
  • Stage IV Melanoma
  • Drug: sorafenib tosylate
    Given orally
    Other Names:
    • BAY 43-9006
    • BAY 43-9006 Tosylate Salt
    • BAY 54-9085
    • Nexavar
    • SFN
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: sorafenib tosylate
  • Other: laboratory biomarker analysis
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. doi: 10.1371/journal.pone.0015588.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
Not Provided
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00119249
NCI-2012-02659, NYWCCC-NYU-0438, N01CM62204, CDR0000434613
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Anna Pavlick Montefiore Medical Center
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP