Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma
Condition: Soft Tissue Sarcoma
MeSH terms: Sarcoma
Intervention: Amrubicin
Intervention description: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously
Intervention MeSH terms: Amrubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objectives

        1. To evaluate the Response Rate (RR) for amrubicin in patients with metastatic or advanced
           sarcoma as first line therapy.

        2. To evaluate Progression Free Survival (PFS).

      Secondary Objectives

        1. To assess the safety and tolerability of amrubicin in this patient population.

        2. To evaluate whether certain histologic subtypes of sarcoma demonstrate a differential
           response to amrubicin.

        3. To investigate quality of response with radiographic evaluation using both Response
           Evaluation Criteria In Solid Tumors (RECIST) and Choi criteria.

        4. To evaluate overall survival (OS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients (age 18 years or older)

          -  Pathological diagnosis of soft tissue sarcoma. Pathology materials must be submitted
             and reviewed.

          -  Patients must have unresectable locally advanced or metastatic progressive disease
             prior to enrollment. Disease extent must be determined by scans (CT or PET CT) within
             6 weeks of enrollment.

          -  No prior chemotherapy for soft tissue sarcoma.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Adequate organ function including the following:

          -  Adequate bone marrow reserve: absolute neutrophil count (segmented and bands) (ANC)
             1.5 x 109/L, platelet count 100 x 109/L, and hemoglobin 90 g/L,

          -  Hepatic: bilirubin 1.5 x the upper limit of normal (ULN), ALT and AST 3.0 x ULN,

          -  Renal: serum creatinine 1.5 x ULN or calculated creatinine clearance greater than 60
             mL/min,

          -  Cardiac: Left ventricular ejection fraction (LVEF) 50% by echocardiogram (ECHO) or
             multiple gated acquisition scan (MUGA);

          -  All labs must be done within 2 weeks prior to enrollment.

          -  Negative serum pregnancy test at the time of enrollment for females of childbearing
             potential;

          -  For males and females of child-producing potential, use of effective contraceptive
             methods during the study;

          -  Ability to understand the requirements of the study and provide written informed
             consent.

        Exclusion Criteria:

          -  Pregnant or nursing females

          -  Chest radiotherapy with curative intent to the primary disease complex less than or
             equal to 28 days prior to first dose; cranial radiotherapy less than or equal to 21
             days prior to first dose; radiotherapy to all other areas less than or equal to 7 days
             prior to first dose

          -  Concurrent severe or uncontrolled medical disease (eg, active systemic infection,
             diabetes, hypertension, coronary artery disease, congestive heart failure, active
             viral hepatitis or chronic liver disease) that, in the opinion of the investigator,
             would compromise the safety of the patient or compromise the ability of the patient to
             complete the study

          -  Symptomatic central nervous system metastases. Patients with asymptomatic brain
             metastases are allowed. The patient must be stable for 2 weeks after radiotherapy; if
             the patient is on corticosteroids, the dose of corticosteroids must have been stable
             for 2 weeks prior to first dose of study treatment, or be in the process of being
             tapered

          -  Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.

          -  Patients with known history of seropositive human immunodeficiency virus (HIV) or
             patients who are receiving immunosuppressive medications that would, in the opinion of
             the investigator, increase the risk of serious neutropenic complications. HIV testing
             is not required for inclusion in the trial.

          -  Known hypersensitivity to any of the components of the i.v. formulation of amrubicin.

          -  Psychiatric disorder or any other personal circumstances that prevent compliance with
             the study protocol.

          -  Inability or unwillingness to comply with the study protocol.