AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma
Condition: Adult Fibrosarcoma; Adult Leiomyosarcoma; Adult Liposarcoma; Adult Malignant Fibrous Histiocytoma; Adult Rhabdomyosarcoma; Dermatofibrosarcoma Protuberans; Endometrial Stromal Sarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Uterine Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage III Uterine Sarcoma; Stage IV Adult Soft Tissue Sarcoma; Stage IV Uterine Sarcoma; Uterine Carcinosarcoma; Uterine Leiomyosarcoma
MeSH terms: Sarcoma; Rhabdomyosarcoma; Leiomyosarcoma; Liposarcoma; Carcinosarcoma; Fibrosarcoma; Histiocytoma; Histiocytoma, Benign Fibrous; Histiocytoma, Malignant Fibrous; Dermatofibrosarcoma; Sarcoma, Endometrial Stromal; Recurrence
Intervention: saracatinib
Intervention description: Given orally
Intervention MeSH terms: Saracatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well AZD0530 works in treating patients with recurrent
      locally advanced, or metastatic soft tissue sarcoma. AZD0530 may stop the growth of tumor
      cells by blocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        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