search
Back to results

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

Primary Purpose

Stage III Melanoma, Stage IV Melanoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sorafenib tosylate
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage III Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (sorafenib tosylate)

Arm 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.

Outcomes

Primary Outcome Measures

Response rate (RR) defined as is either a complete or a partial response using RECIST criteria
The overall response rate along with subgroup-specific response rates will be estimated at the end of the trial along with 95% confidence interval.

Secondary Outcome Measures

Time to progression
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
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
The proportion of patients with decreases in levels of BRAF, CDK4, or phospho-MAPK will be estimated along with 95% confidence intervals.
Overall survival
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.

Full Information

First Posted
July 12, 2005
Last Updated
January 14, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00119249
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III Melanoma, Stage IV Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (sorafenib tosylate)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Other Intervention Name(s)
BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate (RR) defined as is either a complete or a partial response using RECIST criteria
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.
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Time to progression
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.
Time Frame
From the first day of treatment until the first documentation of disease progression, assessed up to 3.5 years
Title
Toxicity assessed using NCI CTCAE version 3.0
Description
All adverse events without regard to causal relationship and by causal relationship to study drugs will be summarized.
Time Frame
Up to 3.5 years
Title
Changes in BRAF, P-MAPK, CDK4, and cyclin D1 levels
Description
The proportion of patients with decreases in levels of BRAF, CDK4, or phospho-MAPK will be estimated along with 95% confidence intervals.
Time Frame
Baseline and up to 3.5 years
Title
Overall survival
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.
Time Frame
Up to 3.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Pavlick
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2490
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21206909
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. doi: 10.1371/journal.pone.0015588.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs