AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma

Inclusion Criteria

• Leukocytes >= 3,000/mcL
• Histologically or cytologically confirmed soft tissue sarcoma including, but not limited to any of:
• 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 two prior lines 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
• ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
• Life expectancy > 12 weeks
• Recovered from all prior therapy
• Platelet count >= 100,000/mcL
• Hemoglobin > 9 g/dL
• Total bilirubin = = 50 mL/min
• Urine protein:creatinine ratio = 1,500/mcL
• 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

Exclusion Criteria

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
• 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
• 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
• No known brain metastases