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

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: Soft Tissue Sarcoma
• Intervention / Treatment: Drug: STA-4783

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

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

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

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

• Sponsor: Synta Pharmaceuticals Corp.

Study record dates

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: sarcoma
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: 4783-04