Clinical trial NCT00084214: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Melanoma
Keywords: metastatic
increased antitumor effect
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2004-06-10
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Little Rock
country: United States
facility: Univ Of Arkansas/Arkansas Research Center
state: Arkansas
city: San Diego
country: United States
facility: Scripps Cancer Center
state: California
city: San Francisco
country: United States
facility: Northern California Melanoma Center
state: California
city: Santa Monica
country: United States
facility: Cancer Institute Medical Group, Inc
state: California
city: Aurora
country: United States
facility: Anschutz Cancer Pavillion - Univ Of Colorado
state: Colorado
city: Stamford
country: United States
facility: Hematology Oncology P.C.
state: Connecticut
city: Waterbury
country: United States
facility: Medical Oncology and Hematology, P.C.
state: Connecticut
city: Atlanta
country: United States
facility: Emory University - Winship Cancer Institute
state: Georgia
city: Honolulu
country: United States
facility: Research Institute Hawaii Pacific Health
state: Hawaii
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Ltd.
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists
state: Illinois
city: Bloomington
country: United States
facility: Cancer Care Center Of Southern Indiana
state: Indiana
city: Goshen
country: United States
facility: Center For Cancer Care At Goshen Health
state: Indiana
city: Iindianapolis
country: United States
facility: Indiana Oncology Hematology Consultants
state: Indiana
city: New Albany
country: United States
facility: Cancer Care Center
state: Indiana
city: Louisville
country: United States
facility: James Graham Brown Cancer Center - University Of Louisville
state: Kentucky
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine & Blood Disorders
state: Maine
city: Robbinsdale
country: United States
facility: Hubert H. Humphrey Cancer Center
state: Minnesota
city: Columbia
country: United States
facility: Ellis Fischels Cancer Center - Univ Of Missouri
state: Missouri
city: St. Louis
country: United States
facility: Mountainside Hospital, Suburban Surgical Associates
state: Missouri
city: Charlotte
country: United States
facility: Piedmont Oncology Specialists
state: North Carolina
city: Bismarck
country: United States
facility: Odyssey Research and St. Alexius Medical Center
state: North Dakota
city: Portland
country: United States
facility: Providence Cancer Center
state: Oregon
city: Danville
country: United States
facility: Danville Hematology & Oncology, Inc.
state: Virginia
city: Portsmouth
country: United States
facility: Office of James Stark, MD
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
Study officials:
References: