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Phase 2
18 Years
Not Enrolling
Soft Tissue Sarcoma

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Trial Information

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.

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

- Use of any investigational agents within 4 weeks prior to the first dose of study

- Major surgery within 2 weeks of screening

- Radiation treatment in past >25% of bone marrow

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

July 2004

Completion Date:

October 2005

Related Keywords:

  • Soft Tissue Sarcoma
  • sarcoma
  • Sarcoma



Arizona Cancer Center Tucson, Arizona  85724
University of Michigan Ann Arbor, Michigan  48109-0624
MD Anderson Cancer Center Houston, Texas  77030-4096
Washington University School of Medicine Saint Louis, Missouri  63110
Genesys Hurley Cancer Institute Flint, Michigan  48503
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Winship Cancer Institute Atlanta, Georgia  30322
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
University of Louisville Hospital Louisville, Kentucky  40202
Palm Beach Cancer Institute West Palm Beach, Florida  33401
University of Florida Gainesville, Florida  32610-0277
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Wayne State University Detroit, Michigan  48202
The Sarah Cannon Cancer Center Nashville, Tennessee  37203
UCLA Los Angeles, California  90095
Oregon Health and Science University Portland, Oregon  97201
The West Clinic Memphis, Tennessee  38120
Yale University School Of Medicine New Haven, Connecticut  06520
Herbert Irving Cancer Center New York, New York  10032-3789
University of Chicago Department of Medicine Chicago, Illinois  60637
Via Christi Regional Med. Center (Wichita CCOP) Wichita, Kansas  67214
Feist-Weiller Cancer Center Shreveport, Louisiana  71103
NYU Cancer Institute Clinical Center New York, New York  10016
Carolinas Medical Center/Blumenthal Cancer Center Charlotte, North Carolina  28203
Hillman Cancer Center Pittsburg, Pennsylvania  15232