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

This is an interventional treatment trial for Adult Fibrosarcoma Read More

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 =< 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
• ANC >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