STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma

March 5, 2014 updated by: Synta Pharmaceuticals Corp.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

103

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
      • Little Rock, Arkansas, United States, 72205-7101
        • Univ Of Arkansas/Arkansas Research Center
    • California
      • San Diego, California, United States, 92121
        • Scripps Cancer Center
      • San Francisco, California, United States, 94109
        • Northern California Melanoma Center
      • Santa Monica, California, United States, 90404
        • Cancer Institute Medical Group, Inc
    • Colorado
      • Aurora, Colorado, United States, 80010
        • Anschutz Cancer Pavillion - Univ Of Colorado
    • Connecticut
      • Stamford, Connecticut, United States, 06902-3628
        • Hematology Oncology P.C.
      • Waterbury, Connecticut, United States, 06708
        • Medical Oncology and Hematology, P.C.
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Emory University - Winship Cancer Institute
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Research Institute Hawaii Pacific Health
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Ltd.
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Cancer Care Center of Southern Indiana
      • Goshen, Indiana, United States, 46527-0139
        • Center For Cancer Care At Goshen Health
      • Iindianapolis, Indiana, United States, 46202
        • Indiana Oncology Hematology Consultants
      • New Albany, Indiana, United States, 47150-6809
        • Cancer Care Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center - University Of Louisville
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Center for Cancer Medicine & Blood Disorders
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422
        • Hubert H. Humphrey Cancer Center
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischels Cancer Center - Univ Of Missouri
      • St. Louis, Missouri, United States, 63131
        • Mountainside Hospital, Suburban Surgical Associates
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Piedmont Oncology Specialists
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Odyssey Research and St. Alexius Medical Center
    • Oregon
      • Portland, Oregon, United States, 97213-2933
        • Providence Cancer Center
    • Virginia
      • Danville, Virginia, United States, 24541-4155
        • Danville Hematology & Oncology, Inc.
      • Portsmouth, Virginia, United States, 23707
        • Office of James Stark, MD
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-0001
        • University of Wisconsin Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synta Pharmaceuticals Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Registration Dates

First Submitted

June 9, 2004

First Submitted That Met QC Criteria

June 9, 2004

First Posted (Estimate)

June 10, 2004

Study Record Updates

Last Update Posted (Estimate)

March 6, 2014

Last Update Submitted That Met QC Criteria

March 5, 2014

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4783-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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