Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
Primary Purpose
Melanoma
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Elesclomol (STA-4783)
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring melanoma, oncology, Stage IV Metastatic Melanoma
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
- ECOG performance status of <=2
- Measurable disease according to modified RECIST
- Life expectancy of greater than 12 weeks
- LDH <= 2.0 x ULN
- Clinical lab values within protocol parameters.
- At least 18 years old and able and willing to provide informed consent to participate
Exclusion Criteria:
- Previous cytotoxic chemotherapy treatment for melanoma
- Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.
- Presence of brain metastases
- Presence or history (<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ
- Female subjects who are pregnant or nursing
Sites / Locations
- Arizona Cancer Center
- Winthrop P. Rockefeller Cancer Institute
- University of California San Diego Moores UCSD Cancer Center
- University of California, San Diego
- The Angeles Clinic & Research Institute
- Jonsson Comprehensive Cancer Center Univ. of California Los Angeles
- Pacific Medical Center Research Institute
- Redwood Regional Medical Group
- Anschutz Cancer Pavillion University of Colorado
- Hematology Oncology, P.C.
- Bay Pines VA Healthcare System
- Univ. of Miami Hospital and Clinics
- MD Anderson Cancer Center
- Piedmont Hospital
- Emory University Winship Cancer Institute
- Rush University Hospital
- Evanston Northwestern Healthcare
- Joliet Oncology/Hematology Associates, LTD
- Oncology Specialists, S.C.
- Oncology Specialists, SC
- Goshen Center for Cancer Care
- Indiana University Melvin and Bren Simon Cancer Center
- Mary Bird Perkins Cancer Center
- Dana Farber Cancer Institute
- Beth Israel Deaconess Medical Center
- Karmanos Cancer Institute, Wayne State University
- Hubert H. Humphrey Cancer Center
- Ellis Fischels Cancer Center
- Southeast Nebraska Hematology/Oncology
- Nebraska Methodist Cancer Center
- Dartmouth Hitchcock Medical Center
- Atlantic Health Research - Mountainside Hospital
- University of New Mexico Cancer Center
- Monter Cancer Center North Shore Hospital
- Weill Medical College of Cornell University - Division of Hematology and Medical Oncology
- NYU Clinical Cancer Center
- Stony Brook University Medical Center- Cancer Center
- UNC School of Medicine - Division of Hematology/Oncology
- Carolina Hematology & Oncology Associates
- Duke University Medical Center
- Leo W. Jenkins Cancer Center
- Brody School of Medicine at East Carolina State University
- Derrick L. Davis Regional Cancer Center
- The Christ Hospital
- The Ohio State University.
- Mark H. Zangmeister Cancer Center
- Providence Cancer Center Clinical Trials
- St. Luke's Cancer Center
- Abramson Cancer Center at University of Pennsylvania
- Fox Chase Cancer Center
- Cancer Pavilion
- Cancer Center of the Carolinas
- Vanderbilt Medical Center
- Texas Oncology, PA
- San Antonio Cancer Institute
- Virginia Oncology Associates
- Virginia Oncology Associates
- Virginia Oncology Associates
- Virginia Cancer Institute
- Seattle Cancer Care Alliance
- Marshfield Clinic
- Lismore Base Hospital, Cancer Care & Haematology Unit
- Newcastle Melanoma Unit - Calvary Mater Newcastle
- Southern Medical Day Care Centre
- Redcliffe Hospital
- Princess Alexandra Hospital
- Royal Hobart Hospital
- Fremantle Hospital
- Royal Adelaide Cancer Centre Medical Oncology
- Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital
- The Tweed Hospital
- Department of Medical Oncology, Westmead Hospital
- Tom Baker Cancer Centre
- QE II Health Sciences Center
- Northeastern Ontario Regional Cancer Centre
- Cross Cancer Institute
- Princess Margaret Hospital
- Vivantes Klinikum Im Friedrichshain
- Vivantes Klinikum Neukölln
- Elbe-Klinikum Buxtehude
- University Frankfurt
- University of Kiel
- Universität zu Köln
- Universitätsklinikum Leipzig
- Universitätsklinikum Mannheim
- Universitätsklinikum Münster
- Universitätsklinikum Würzburg
- VA Medical Center
- County Hospital Brasov - Oncology Department
- Oncology Institute "Prof. Dr. Ion Chiricuta"
- Clinical County Hospital " Alexandru Simionescu" Hunedoara
- Center of Medical Oncology
- Clinical County Hospital Sibiu
- Oncology- Chemotherapy Clinic - Emergency Municipal Clinical Hospital
- Hospital Universitario Central de Asturias
- Hospital Universitario de la Princessa Servicio de Oncología Médica
- Clinica Universitaria de Navarra
- Hospital Virgen de la Salud - Servicio de Oncología Médica Ciclos
- Oncology Centre Addenbrookes's Hospital
- Northern Centre for Cancer Treatment Newcastle General Hospital
- Dorset Cancer Centre Poole Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
1
2
Arm Description
Elesclomol (STA-4783) in Combination With Paclitaxel
Paclitaxel alone
Outcomes
Primary Outcome Measures
Progression free survival
Secondary Outcome Measures
Overall Survival
Objective response rate
Clinical benefit rate
Duration of objective response
Safety
Pharmacokinetics
Full Information
NCT ID
NCT00522834
First Posted
August 28, 2007
Last Updated
January 31, 2014
Sponsor
Synta Pharmaceuticals Corp.
1. Study Identification
Unique Protocol Identification Number
NCT00522834
Brief Title
Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
Official Title
A Randomized, Double-blind, Phase 3 Trial of Elesclomol (STA-4783) in Combination With Paclitaxel Versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects With Stage IV Metastatic Melanoma (SYMMETRY)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synta Pharmaceuticals Corp.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
"Elesclomol (STA-4783), N-malonyl-bis (N'-methyl-N'-thiobenzoylhydrazide) is a new chemical entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This response is characterized by increased production of gene families that protect against different cellular stresses, including excessive heat, the presence of reactive oxygen species such as oxygen radicals, or the presence of heavy metals.
Subjects will participate in up to 2 weeks of screening during which time they will complete all screening procedures. Eligible subjects who have not received any prior cytotoxic chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone.
One treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments will be performed every 8 weeks from the date of randomization or sooner if the Investigator suspects progression has occurred based on clinical signs and symptoms. "
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
melanoma, oncology, Stage IV Metastatic Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
630 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Elesclomol (STA-4783) in Combination With Paclitaxel
Arm Title
2
Arm Type
Other
Arm Description
Paclitaxel alone
Intervention Type
Drug
Intervention Name(s)
Elesclomol (STA-4783)
Intervention Description
213 mg/m2 Elesclomol (STA-4783) plus 80 mg/m2 paclitaxel administered intravenously once a week for the first 3 weeks of a 4 week cycle. Number of cycles: Until progression or unacceptable toxicity develops
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
80 mg/m2 paclitaxel alone administered intravenously once a week for the first 3 weeks of a 4 weeks cycle. Number of cycles: Until progression or unacceptable toxicity develops
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
June 2009
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
December 2009
Title
Objective response rate
Time Frame
December 2009
Title
Clinical benefit rate
Time Frame
December 2009
Title
Duration of objective response
Time Frame
December 2009
Title
Safety
Time Frame
December 2009
Title
Pharmacokinetics
Time Frame
December 2009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
ECOG performance status of <=2
Measurable disease according to modified RECIST
Life expectancy of greater than 12 weeks
LDH <= 2.0 x ULN
Clinical lab values within protocol parameters.
At least 18 years old and able and willing to provide informed consent to participate
Exclusion Criteria:
Previous cytotoxic chemotherapy treatment for melanoma
Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.
Presence of brain metastases
Presence or history (<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ
Female subjects who are pregnant or nursing
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Winthrop P. Rockefeller Cancer Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California San Diego Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
The Angeles Clinic & Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center Univ. of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pacific Medical Center Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Redwood Regional Medical Group
City
Santa Rosa
State/Province
California
ZIP/Postal Code
94503
Country
United States
Facility Name
Anschutz Cancer Pavillion University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Hematology Oncology, P.C.
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Bay Pines VA Healthcare System
City
Bay Pines
State/Province
Florida
Country
United States
Facility Name
Univ. of Miami Hospital and Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
MD Anderson Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rush University Hospital
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Joliet Oncology/Hematology Associates, LTD
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Oncology Specialists, S.C.
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Oncology Specialists, SC
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Goshen Center for Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute, Wayne State University
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Hubert H. Humphrey Cancer Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Ellis Fischels Cancer Center
City
Columbia
State/Province
Missouri
Country
United States
Facility Name
Southeast Nebraska Hematology/Oncology
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Nebraska Methodist Cancer Center
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Atlantic Health Research - Mountainside Hospital
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
Monter Cancer Center North Shore Hospital
City
Lake Success
State/Province
New York
Country
United States
Facility Name
Weill Medical College of Cornell University - Division of Hematology and Medical Oncology
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
NYU Clinical Cancer Center
City
New York
State/Province
New York
Country
United States
Facility Name
Stony Brook University Medical Center- Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-9446
Country
United States
Facility Name
UNC School of Medicine - Division of Hematology/Oncology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolina Hematology & Oncology Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Leo W. Jenkins Cancer Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Brody School of Medicine at East Carolina State University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Derrick L. Davis Regional Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Ohio State University.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Mark H. Zangmeister Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Providence Cancer Center Clinical Trials
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
St. Luke's Cancer Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Abramson Cancer Center at University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Cancer Pavilion
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15323
Country
United States
Facility Name
Cancer Center of the Carolinas
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
27232-6868
Country
United States
Facility Name
Texas Oncology, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
San Antonio Cancer Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Oncology Associates
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Virginia Oncology Associates
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Lismore Base Hospital, Cancer Care & Haematology Unit
City
Lismore
State/Province
New South Wales
Country
Australia
Facility Name
Newcastle Melanoma Unit - Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Redcliffe Hospital
City
Redcliffe
State/Province
Queensland
ZIP/Postal Code
4020
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Wooloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Royal Adelaide Cancer Centre Medical Oncology
City
Adelaide
ZIP/Postal Code
SA 5000
Country
Australia
Facility Name
Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital
City
North Sydney
Country
Australia
Facility Name
The Tweed Hospital
City
Tweed Heads
Country
Australia
Facility Name
Department of Medical Oncology, Westmead Hospital
City
Westmead
Country
Australia
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
QE II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Northeastern Ontario Regional Cancer Centre
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
ZIP/Postal Code
AB T6G 1Z2
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toranto
Country
Canada
Facility Name
Vivantes Klinikum Im Friedrichshain
City
Berlin
Country
Germany
Facility Name
Vivantes Klinikum Neukölln
City
Berlin
Country
Germany
Facility Name
Elbe-Klinikum Buxtehude
City
Buxtehude
Country
Germany
Facility Name
University Frankfurt
City
Frankfurt/Main
Country
Germany
Facility Name
University of Kiel
City
Kiel
Country
Germany
Facility Name
Universität zu Köln
City
Köln
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Universitätsklinikum Mannheim
City
Mannheim
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
Country
Germany
Facility Name
VA Medical Center
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
County Hospital Brasov - Oncology Department
City
Brasov
ZIP/Postal Code
500 117
Country
Romania
Facility Name
Oncology Institute "Prof. Dr. Ion Chiricuta"
City
Cluj Napoca
ZIP/Postal Code
400 015
Country
Romania
Facility Name
Clinical County Hospital " Alexandru Simionescu" Hunedoara
City
Hunedoara
ZIP/Postal Code
331 057
Country
Romania
Facility Name
Center of Medical Oncology
City
Iasi
ZIP/Postal Code
700 106
Country
Romania
Facility Name
Clinical County Hospital Sibiu
City
Sibiu
ZIP/Postal Code
550 245
Country
Romania
Facility Name
Oncology- Chemotherapy Clinic - Emergency Municipal Clinical Hospital
City
Timisoara
ZIP/Postal Code
300 223
Country
Romania
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Universitario de la Princessa Servicio de Oncología Médica
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Virgen de la Salud - Servicio de Oncología Médica Ciclos
City
Toledo
Country
Spain
Facility Name
Oncology Centre Addenbrookes's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment Newcastle General Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Dorset Cancer Centre Poole Hospital NHS Foundation Trust
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23401447
Citation
O'Day SJ, Eggermont AM, Chiarion-Sileni V, Kefford R, Grob JJ, Mortier L, Robert C, Schachter J, Testori A, Mackiewicz J, Friedlander P, Garbe C, Ugurel S, Collichio F, Guo W, Lufkin J, Bahcall S, Vukovic V, Hauschild A. Final results of phase III SYMMETRY study: randomized, double-blind trial of elesclomol plus paclitaxel versus paclitaxel alone as treatment for chemotherapy-naive patients with advanced melanoma. J Clin Oncol. 2013 Mar 20;31(9):1211-8. doi: 10.1200/JCO.2012.44.5585. Epub 2013 Feb 11.
Results Reference
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Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
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