Clinical trial NCT00087997: A Study of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Soft Tissue Sarcomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Keywords: sarcoma
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2004-07-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Department of Medicine
state: Illinois
city: Wichita
country: United States
facility: Via Christi Regional Med. Center (Wichita CCOP)
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Shreveport
country: United States
facility: Feist-Weiller Cancer Center
state: Louisiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: NYU Cancer Institute Clinical Center
state: New York
city: New York
country: United States
facility: Herbert Irving Cancer Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center/Blumenthal Cancer Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburg
country: United States
facility: Hillman Cancer Center
state: Pennsylvania
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Nashville
country: United States
facility: The Sarah Cannon Cancer Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
References: