STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma
- Conditions
- Melanoma
- Registration Number
- NCT00084214
- Lead Sponsor
- Synta Pharmaceuticals Corp.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Piedmont Oncology Specialists
🇺🇸Charlotte, North Carolina, United States
James Graham Brown Cancer Center - University Of Louisville
🇺🇸Louisville, Kentucky, United States
Univ Of Arkansas/Arkansas Research Center
🇺🇸Little Rock, Arkansas, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Indiana Oncology Hematology Consultants
🇺🇸Iindianapolis, Indiana, United States
Danville Hematology & Oncology, Inc.
🇺🇸Danville, Virginia, United States
Providence Cancer Center
🇺🇸Portland, Oregon, United States
Cancer Care Center
🇺🇸New Albany, Indiana, United States
Ellis Fischels Cancer Center - Univ Of Missouri
🇺🇸Columbia, Missouri, United States
Mountainside Hospital, Suburban Surgical Associates
🇺🇸St. Louis, Missouri, United States
Hematology Oncology P.C.
🇺🇸Stamford, Connecticut, United States
Maine Center for Cancer Medicine & Blood Disorders
🇺🇸Scarborough, Maine, United States
Odyssey Research and St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Cancer Institute Medical Group, Inc
🇺🇸Santa Monica, California, United States
Office of James Stark, MD
🇺🇸Portsmouth, Virginia, United States
Hubert H. Humphrey Cancer Center
🇺🇸Robbinsdale, Minnesota, United States
Scripps Cancer Center
🇺🇸San Diego, California, United States
Northern California Melanoma Center
🇺🇸San Francisco, California, United States
Anschutz Cancer Pavillion - Univ Of Colorado
🇺🇸Aurora, Colorado, United States
Medical Oncology and Hematology, P.C.
🇺🇸Waterbury, Connecticut, United States
Emory University - Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Research Institute Hawaii Pacific Health
🇺🇸Honolulu, Hawaii, United States
Oncology Specialists
🇺🇸Park Ridge, Illinois, United States
Joliet Oncology-Hematology Associates, Ltd.
🇺🇸Joliet, Illinois, United States
Center For Cancer Care At Goshen Health
🇺🇸Goshen, Indiana, United States
Cancer Care Center Of Southern Indiana
🇺🇸Bloomington, Indiana, United States
University of Wisconsin Medical School
🇺🇸Madison, Wisconsin, United States