The purpose of this study is to compare the progression free survival in patients with advanced soft tissue sarcoma not amenable to treatment with surgery or radiotherapy when treated with IMC-3G3 in combination with doxorubicin versus doxorubicin alone. IMC-3G3 is a recombinant human monoclonal antibody of the IgG1 which specifically targets the human PDGFRa. Patients will be randomized into Arm A- IMC-3G3 and doxorubicin or Arm B - doxorubicin only. Eligible patients will receive treatment
Who may be Eligible
Key eligibility:
The patient has histologically- or cytologically-confirmed malignant soft tissue sarcoma (STS), including uterine leiomyosarcoma. Patients with Kaposi’s sarcoma will be excluded.
The patient has measurable disease.
The patient has advanced STS, not amenable to treatment with surgery or radiotherapy. Prior treatment with systemic cytotoxic and/or non-PDGF/PDGFR-directed therapy is not required for patient eligibility, nor is there a limit on the number of prior treatment regimens.
The patient’s Eastern Cooperative Oncology Group (ECOG) performance status is 0-2.
The patient has available tumor tissue from either the primary or metastatic tumor for determination of PDGFRa expression.
The patient’s age at study entry is = 18 years.
The patient has adequate organ and marrow function as defined per protocol.
The patient has a prestudy echocardiogram or multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction (LVEH) = 50%, within 21 days prior to first dose of study medication.
The patient would be excluded if they received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones (ie, mitoxantrone).
The patient would be excluded if they received prior radiation therapy to the mediastinal/pericardial area.
The patient would be excluded if they have received previous therapy with any agent that targets the PDGF or PDGFR.
