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Phase 2
18 Years
N/A
Not Enrolling
Both
Soft Tissue Sarcoma

Thank you

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
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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

4783-04

NCT ID:

NCT00087997

Start Date:

July 2004

Completion Date:

October 2005

Related Keywords:

  • Soft Tissue Sarcoma
  • sarcoma
  • Sarcoma

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of MichiganAnn Arbor, Michigan  48109-0624
MD Anderson Cancer CenterHouston, Texas  77030-4096
Washington University School of MedicineSaint Louis, Missouri  63110
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Winship Cancer InstituteAtlanta, Georgia  30322
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
University of Louisville HospitalLouisville, Kentucky  40202
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
University of FloridaGainesville, Florida  32610-0277
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Wayne State UniversityDetroit, Michigan  48202
The Sarah Cannon Cancer CenterNashville, Tennessee  37203
UCLALos Angeles, California  90095
Oregon Health and Science UniversityPortland, Oregon  97201
The West ClinicMemphis, Tennessee  38120
Yale University School Of MedicineNew Haven, Connecticut  06520
Herbert Irving Cancer CenterNew York, New York  10032-3789
University of Chicago Department of MedicineChicago, Illinois  60637
Via Christi Regional Med. Center (Wichita CCOP)Wichita, Kansas  67214
Feist-Weiller Cancer CenterShreveport, Louisiana  71103
NYU Cancer Institute Clinical CenterNew York, New York  10016
Carolinas Medical Center/Blumenthal Cancer CenterCharlotte, North Carolina  28203
Hillman Cancer CenterPittsburg, Pennsylvania  15232