STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma

NCT00084214 | Completed Phase 1

• 1 other identifier: 4783-03
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 28

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.

Conditions

Melanoma

Keywords

metastatic; increased antitumor effect

Interventions

STA-4783 DRUG

Paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Synta Pharmaceuticals Corp.: lead

Study Sites (28)

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

Univ Of Arkansas/Arkansas Research Center

Little Rock, Arkansas, 72205-7101, United States

Location

Scripps Cancer Center

San Diego, California, 92121, United States

Location

Northern California Melanoma Center

San Francisco, California, 94109, United States

Location

Cancer Institute Medical Group, Inc

Santa Monica, California, 90404, United States

Location

Anschutz Cancer Pavillion - Univ Of Colorado

Aurora, Colorado, 80010, United States

Location

Hematology Oncology P.C.

Stamford, Connecticut, 06902-3628, United States

Location

Medical Oncology and Hematology, P.C.

Waterbury, Connecticut, 06708, United States

Location

Emory University - Winship Cancer Institute

Atlanta, Georgia, 30322-1013, United States

Location

Research Institute Hawaii Pacific Health

Honolulu, Hawaii, 96813, United States

Location

Joliet Oncology-Hematology Associates, Ltd.

Joliet, Illinois, 60435, United States

Location

Oncology Specialists

Park Ridge, Illinois, 60068, United States

Location

Cancer Care Center Of Southern Indiana

Bloomington, Indiana, 47403, United States

Location

Center For Cancer Care At Goshen Health

Goshen, Indiana, 46527-0139, United States

Location

Indiana Oncology Hematology Consultants

Iindianapolis, Indiana, 46202, United States

Location

Cancer Care Center

New Albany, Indiana, 47150-6809, United States

Location

James Graham Brown Cancer Center - University Of Louisville

Louisville, Kentucky, 40202, United States

Location

Maine Center for Cancer Medicine & Blood Disorders

Scarborough, Maine, 04074, United States

Location

Hubert H. Humphrey Cancer Center

Robbinsdale, Minnesota, 55422, United States

Location

Ellis Fischels Cancer Center - Univ Of Missouri

Columbia, Missouri, 65203, United States

Location

Mountainside Hospital, Suburban Surgical Associates

St Louis, Missouri, 63131, United States

Location

Piedmont Oncology Specialists

Charlotte, North Carolina, 28207, United States

Location

Odyssey Research and St. Alexius Medical Center

Bismarck, North Dakota, 58501, United States

Location

Providence Cancer Center

Portland, Oregon, 97213-2933, United States

Location

Danville Hematology & Oncology, Inc.

Danville, Virginia, 24541-4155, United States

Location

Office of James Stark, MD

Portsmouth, Virginia, 23707, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

University of Wisconsin Medical School

Madison, Wisconsin, 53792-0001, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

elesclomol; Paclitaxel

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2004
• First Posted: June 10, 2004
• Study Start: May 1, 2004
• Last Updated: March 6, 2014

Record last verified: 2008-12

Locations

US (28)