STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma

Completed · Phase 1/Phase 2

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT00084214

Run by

Synta Pharmaceuticals Corp.

People needed

103

Starts

2004-05-01

Last updated by the study team

2014-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Genesis Cancer Center — Hot Springs, Arkansas, United States
• Univ Of Arkansas/Arkansas Research Center — Little Rock, Arkansas, United States
• Scripps Cancer Center — San Diego, California, United States
• Northern California Melanoma Center — San Francisco, California, United States
• Cancer Institute Medical Group, Inc — Santa Monica, California, United States
• Anschutz Cancer Pavillion - Univ Of Colorado — Aurora, Colorado, United States
• Hematology Oncology P.C. — Stamford, Connecticut, 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
• Joliet Oncology-Hematology Associates, Ltd. — Joliet, Illinois, United States
• Oncology Specialists — Park Ridge, Illinois, United States
• Cancer Care Center Of Southern Indiana — Bloomington, Indiana, United States
• Center For Cancer Care At Goshen Health — Goshen, Indiana, United States
• Indiana Oncology Hematology Consultants — Iindianapolis, Indiana, United States
• Cancer Care Center — New Albany, Indiana, United States
• James Graham Brown Cancer Center - University Of Louisville — Louisville, Kentucky, United States
• Maine Center for Cancer Medicine & Blood Disorders — Scarborough, Maine, United States
• Hubert H. Humphrey Cancer Center — Robbinsdale, Minnesota, United States
• Ellis Fischels Cancer Center - Univ Of Missouri — Columbia, Missouri, United States
• Mountainside Hospital, Suburban Surgical Associates — St Louis, Missouri, United States
• Piedmont Oncology Specialists — Charlotte, North Carolina, United States
• Odyssey Research and St. Alexius Medical Center — Bismarck, North Dakota, United States
• Providence Cancer Center — Portland, Oregon, United States
• Danville Hematology & Oncology, Inc. — Danville, Virginia, United States

Full record on ClinicalTrials.gov

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