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NCT00084214 Clinical Trial

STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma

Melanoma Clinical Trial

Official title:
A Two-Stage Trial of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00084214
Other study ID # 4783-03
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received June 9, 2004
Last updated March 5, 2014
Start date May 2004

Study information
Verified date December 2008
Source Synta Pharmaceuticals Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 103
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• STA-4783

• Paclitaxel

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

Sponsors (1)
Lead Sponsor Collaborator
Synta Pharmaceuticals Corp.

Country where clinical trial is conducted

United States, 

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