Back to resultsSTA-4783/Paclitaxel or Paclitaxel Alone in Melanoma
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STA-4783
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring metastatic, increased antitumor effect
Eligibility Criteria
Inclusion Criteria: M or F 18 or older with histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin ECOG performance status of greater than or equal to 2 Measurable disease per RECIST criteria Received no more than 1 regimen of prior chemotherapy (unlimited immunotherapy regimens are allowed) At least 4 weeks have passed since last chemotherapy or immunotherapy At least 2 weeks have passed since last radiotherapy. Life expectancy of greater than 12 weeks Clinical lab values within protocol parameters Exclusion Criteria: Female patients pregnant or lactating Female patients of childbearing potential not using or not willing to use effective contraception Presence of a second malignancy other than nonmelanoma skin cancer Presence of a clinically significant and uncontrolled infection Presence of clinically significant arrythmias Presence of serious concurrent illness or other conditions that do not permit adequate follow-up and compliance with protocol History of severe hypersensitivity reactions to taxanes Use of any investigational agents within 4 weeks prior to the first dose of study drug
Sites / Locations
- Genesis Cancer Center
- Univ Of Arkansas/Arkansas Research Center
- Scripps Cancer Center
- Northern California Melanoma Center
- Cancer Institute Medical Group, Inc
- Anschutz Cancer Pavillion - Univ Of Colorado
- Hematology Oncology P.C.
- Medical Oncology and Hematology, P.C.
- Emory University - Winship Cancer Institute
- Research Institute Hawaii Pacific Health
- Joliet Oncology-Hematology Associates, Ltd.
- Oncology Specialists
- Cancer Care Center Of Southern Indiana
- Center For Cancer Care At Goshen Health
- Indiana Oncology Hematology Consultants
- Cancer Care Center
- James Graham Brown Cancer Center - University Of Louisville
- Maine Center for Cancer Medicine & Blood Disorders
- Hubert H. Humphrey Cancer Center
- Ellis Fischels Cancer Center - Univ Of Missouri
- Mountainside Hospital, Suburban Surgical Associates
- Piedmont Oncology Specialists
- Odyssey Research and St. Alexius Medical Center
- Providence Cancer Center
- Danville Hematology & Oncology, Inc.
- Office of James Stark, MD
- Virginia Cancer Institute
- University of Wisconsin Medical School
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00084214
First Posted
June 9, 2004
Last Updated
March 5, 2014
Sponsor
Synta Pharmaceuticals Corp.
1. Study Identification
Unique Protocol Identification Number
NCT00084214
Brief Title
STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma
Official Title
A Two-Stage Trial of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Metastatic Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synta Pharmaceuticals Corp.
4. Oversight
5. Study Description
Brief Summary
This study is designed to assess the efficacy of a weekly treatment regimen of STA-4783 and paclitaxel in comparison to paclitaxel alone on tumor response in metastatic melanoma patients.
Detailed Description
STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents. When paclitaxel is combined with other anticancer agents, although response rate is usually increased, side effects are usually increased as well. There is an urgent need for agents that can enhance the antitumor effects of paclitaxel without further increasing undesirable side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
metastatic, increased antitumor effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
103 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
STA-4783
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
M or F 18 or older with histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
ECOG performance status of greater than or equal to 2
Measurable disease per RECIST criteria
Received no more than 1 regimen of prior chemotherapy (unlimited immunotherapy regimens are allowed)
At least 4 weeks have passed since last chemotherapy or immunotherapy
At least 2 weeks have passed since last radiotherapy.
Life expectancy of greater than 12 weeks
Clinical lab values within protocol parameters
Exclusion Criteria:
Female patients pregnant or lactating
Female patients of childbearing potential not using or not willing to use effective contraception
Presence of a second malignancy other than nonmelanoma skin cancer
Presence of a clinically significant and uncontrolled infection
Presence of clinically significant arrythmias
Presence of serious concurrent illness or other conditions that do not permit adequate follow-up and compliance with protocol
History of severe hypersensitivity reactions to taxanes
Use of any investigational agents within 4 weeks prior to the first dose of study drug
Facility Information:
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Univ Of Arkansas/Arkansas Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205-7101
Country
United States
Facility Name
Scripps Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Northern California Melanoma Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Cancer Institute Medical Group, Inc
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Anschutz Cancer Pavillion - Univ 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
06902-3628
Country
United States
Facility Name
Medical Oncology and Hematology, P.C.
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Emory University - Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
Research Institute Hawaii Pacific Health
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
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
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Cancer Care Center Of Southern Indiana
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Center For Cancer Care At Goshen Health
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46527-0139
Country
United States
Facility Name
Indiana Oncology Hematology Consultants
City
Iindianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Cancer Care Center
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150-6809
Country
United States
Facility Name
James Graham Brown Cancer Center - University Of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Maine Center for Cancer Medicine & Blood Disorders
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
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 - Univ Of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Mountainside Hospital, Suburban Surgical Associates
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Piedmont Oncology Specialists
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Odyssey Research and St. Alexius Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Providence Cancer Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2933
Country
United States
Facility Name
Danville Hematology & Oncology, Inc.
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541-4155
Country
United States
Facility Name
Office of James Stark, MD
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23707
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
University of Wisconsin Medical School
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
12. IPD Sharing Statement
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STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma
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