Cixutumumab and Doxorubicin Hydrochloride in Treating Patients With Unresectable, Locally Advanced, or Metastatic Soft Tissue Sarcoma

You may be eligible if

• Histologically or cytologically confirmed soft tissue sarcoma
• * Unresectable disease
• * Locally advanced or metastatic disease
• The following tumor types are not allowed:
• * Embryonal and alveolar rhabdomyosarcoma
• * Gastrointestinal stromal tumor
• * Alveolar soft part sarcoma
• * Clear cell sarcoma
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• No more than 1 prior therapy for sarcoma
• No known brain metastases
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• ANC ≥ 1,500/µL
• Platelet count ≥ 100,000/µL
• Leukocytes ≥ 3,000/µL
• Total bilirubin ≤ upper limit of normal(ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• Fasting serum glucose \< 120 mg/dL OR below ULN
• LVEF ≥ 50% by MUGA scan
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after the last dose of anti-IGF-1R recombinant monoclonal antibody IMC-A12
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to anti-IGF-1R recombinant monoclonal antibody IMC-A12
• No poorly controlled diabetes mellitus
• * Patients with a history of diabetes mellitus are eligible provided their blood glucose is within normal range and they are on a stable dietary or therapeutic regimen for this condition
• No concurrent uncontrolled illness including, but not limited to, any of the following:
• * Ongoing or active infection
• * Symptomatic congestive heart failure
• * Unstable angina pectoris
• * Cardiac arrhythmia
• * Psychiatric illness or social situation that would preclude compliance with study requirements
• No other concurrent investigational or commercial agents or therapies
• Recovered from all prior therapy
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
• More than 4 weeks since prior major surgery, hormonal therapy (other than replacement), or hormonal therapy
• * No prior radiotherapy to the heart, mediastinum, or chest wall
• No prior anthracycline therapy or anti-IGF-1R therapy