STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma

NCT ID: NCT00084214

Last Updated: 2014-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Brief Summary

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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

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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.

Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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STA-4783

Intervention Type DRUG

Paclitaxel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synta Pharmaceuticals Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Genesis Cancer Center

Hot Springs, Arkansas, United States

Site Status

Univ Of Arkansas/Arkansas Research Center

Little Rock, Arkansas, United States

Site Status

Scripps Cancer Center

San Diego, California, United States

Site Status

Northern California Melanoma Center

San Francisco, California, United States

Site Status

Cancer Institute Medical Group, Inc

Santa Monica, California, United States

Site Status

Anschutz Cancer Pavillion - Univ Of Colorado

Aurora, Colorado, United States

Site Status

Hematology Oncology P.C.

Stamford, Connecticut, United States

Site Status

Medical Oncology and Hematology, P.C.

Waterbury, Connecticut, United States

Site Status

Emory University - Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Research Institute Hawaii Pacific Health

Honolulu, Hawaii, United States

Site Status

Joliet Oncology-Hematology Associates, Ltd.

Joliet, Illinois, United States

Site Status

Oncology Specialists

Park Ridge, Illinois, United States

Site Status

Cancer Care Center Of Southern Indiana

Bloomington, Indiana, United States

Site Status

Center For Cancer Care At Goshen Health

Goshen, Indiana, United States

Site Status

Indiana Oncology Hematology Consultants

Iindianapolis, Indiana, United States

Site Status

Cancer Care Center

New Albany, Indiana, United States

Site Status

James Graham Brown Cancer Center - University Of Louisville

Louisville, Kentucky, United States

Site Status

Maine Center for Cancer Medicine & Blood Disorders

Scarborough, Maine, United States

Site Status

Hubert H. Humphrey Cancer Center

Robbinsdale, Minnesota, United States

Site Status

Ellis Fischels Cancer Center - Univ Of Missouri

Columbia, Missouri, United States

Site Status

Mountainside Hospital, Suburban Surgical Associates

St Louis, Missouri, United States

Site Status

Piedmont Oncology Specialists

Charlotte, North Carolina, United States

Site Status

Odyssey Research and St. Alexius Medical Center

Bismarck, North Dakota, United States

Site Status

Providence Cancer Center

Portland, Oregon, United States

Site Status

Danville Hematology & Oncology, Inc.

Danville, Virginia, United States

Site Status

Office of James Stark, MD

Portsmouth, Virginia, United States

Site Status

Virginia Cancer Institute

Richmond, Virginia, United States

Site Status

University of Wisconsin Medical School

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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4783-03

Identifier Type: -

Identifier Source: org_study_id

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