• Disease control rate or objective tumor response plus prolonged stable disease rate (defined as partial or complete response by RECIST criteria, or stable disease > 4 months) [ Designated as safety issue: No ]
  

• Objective response rate [ Designated as safety issue: No ]
  
• Median survival time [ Designated as safety issue: No ]
  
• Overall survival (i.e., median, 6-month, and 1-year) [ Designated as safety issue: No ]
  
• Response and stable disease duration [ Designated as safety issue: No ]
  
• Time to disease progression (i.e., median, 6-month, 1-year) [ Designated as safety issue: No ]
  
• Stable disease rate [ Designated as safety issue: No ]
  
• Toxicity [ Designated as safety issue: Yes ]
  

OBJECTIVES:

• To assess the efficacy of AZD0530, in terms of disease control rate (i.e., response rate and stable disease rate), in patients with recurrent locally advanced or metastatic soft tissue sarcoma.
• To assess the toxicity, time to progression, and response duration of AZD0530 in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 8 weeks.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed soft tissue sarcoma including, but not limited to, any of the following disease sites:

  • Malignant fibrous histiocytoma
  • Fibrosarcoma - non infantile
  • Leiomyosarcoma - not uterine
  • Liposarcoma
  • Non-rhabdomyosarcoma soft tissue sarcoma
  • Rhabdomyosarcoma, not otherwise specified
  • Carcinosarcoma of the uterus
  • Dermatofibrosarcoma
  • Endometrial stromal sarcoma
  • Leiomyosarcoma - uterus

• Recurrent or locally advanced or metastatic disease

  • No more than one prior line of chemotherapy for metastatic disease (not including adjuvant chemotherapy)

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

  • Target measurable lesion must not have been in previous radiation portal, unless progression of this lesion after radiotherapy has been documented
• No known brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
• Life expectancy > 12 weeks
• Leukocytes ≥ 3,000/mcL
• ANC > 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Hemoglobin > 9 g/dL
• Total bilirubin ≤ 1.25 times upper limit of normal (ULN)
• AST and ALT ≤ 3 times ULN
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
• Urine protein:creatinine ratio ≤ 1.0 OR 24-hour urine protein < 1,000 mg
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 8 weeks after completion of study therapy
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
• No QTc prolongation (defined as a QTc interval ≥ to 460 msecs) or other significant ECG abnormalities
• No poorly controlled hypertension (i.e., systolic blood pressure (BP) ≥ 140 mm Hg, or diastolic BP ≥ 90 mm Hg)

• No condition that impairs a patient's ability to swallow AZD0530 tablets, including any of the following:

  • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
  • Prior surgical procedures affecting absorption
  • Active peptic ulcer disease

• No intercurrent cardiac dysfunction including, but not limited to, any of the following:

  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
• No history of ischemic heart disease, including myocardial infarction
• No uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from all prior therapy
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
• More than 4 weeks since prior radiotherapy
• More than 7 days since prior and no concurrent prohibited CYP3A4-active agents or substances
• No other concurrent investigational agents or commercial agents or therapies
• No concurrent combination antiretroviral therapy for HIV-positive patients