A Study of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Soft Tissue Sarcomas

June 19, 2006 updated by: Synta Pharmaceuticals Corp.
The purpose of this study is to evaluate the safety and effectiveness of an experimental study drug (STA-4783) combined with an approved cancer medicine, paclitaxel, in the treatment of soft tissue sarcomas. Paclitaxel (Taxol®) has been approved and used in the United States since 1992.

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

80

Phase

  • Phase 2

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Arizona Cancer Center
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • California
      • Los Angeles, California, United States, 90095
        • UCLA
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Cancer Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Department of Medicine
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Med. Center (Wichita CCOP)
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Feist-Weiller Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10016
        • NYU Cancer Institute Clinical Center
      • New York, New York, United States, 10032
        • Herbert Irving Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center/Blumenthal Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Pittsburg, Pennsylvania, United States, 15232
        • Hillman Cancer Center
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

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:

  • Must be 18 years of age or older with histologic diagnosis of soft tissue sarcoma
  • Must have disease not suitable for curative resection
  • Must have failed >1 first line treatment with evidence of progression. Adjuvant therapy does not count as 1st line therapy unless recurrence occurs within 6 months of administration
  • Must have ability to understand and the willingness to sign a written informed consent document
  • Must have Eastern Cooperative Oncology Group (ECOG) performance status of < 2
  • Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • At least 4 weeks have passed since the last chemotherapy, immunotherapy, or radiation therapy
  • There must be measurable disease outside the radiotherapy fields or progression of the indicator lesions within the field since the completion of the radiotherapy
  • Must have a life expectancy of greater than 12 weeks
  • Must have clinical laboratory values at screening as defined below:
  • Hemoglobin >9 g/dL,
  • Absolute neutrophil count >1500/mm3,
  • Platelet count >100,000/mm3,
  • Creatinine <1.5 X ULN,
  • Bilirubin <1.5 X ULN,
  • Asparate aminotransferase and alanine aminotransferase <2.5 X ULN (<5 X ULN in presence of liver metastases)

Exclusion Criteria:

  • Female patients who are pregnant or breast feeding
  • Patients of childbearing potential not using or not willing to use a barrier method of contraception

  • Prior malignancy other than soft tissue sarcoma (STS) within the last 5 yrs with the exception of:

    • Adequately treated in situ carcinoma of the cervix uteri;
    • Basal or squamous cell carcinoma of the skin
  • Presence of a clinically significant and uncontrolled infection
  • Presence of >Grade 2 neuropathy
  • Symptomatic central nervous system metastases within last 8 weeks or on corticosteroids for CNS symptom management
  • Presence of clinically significant arrythmias
  • Presence of a serious concurrent illness or other conditions (e.g., psychological, family, sociological, or geographical circumstances) that do not permit adequate follow-up and compliance with the protocol
  • History of severe hypersensitivity reactions to taxanes or cremaphore in spite of premedication
  • Use of any investigational agents within 4 weeks prior to the first dose of study drug(s)
  • Major surgery within 2 weeks of screening
  • Radiation treatment in past >25% of bone marrow

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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

July 1, 2004

Study Completion

October 1, 2005

Study Registration Dates

First Submitted

July 19, 2004

First Submitted That Met QC Criteria

July 22, 2004

First Posted (Estimate)

July 23, 2004

Study Record Updates

Last Update Posted (Estimate)

June 20, 2006

Last Update Submitted That Met QC Criteria

June 19, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4783-04

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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