Trial Information

Summary: A phase II study of Sutent (Sunitinib)for patients with locally advanced or metastatic vascular sarcoma

The primary objective of this phase II study is to evaluate the efficacy of treatment with Sutent in unresectable or metastatic vascular sarcoma. Patients can be treated with up to two prior chemotherapy regimens or with prior bevacizamab or tyrosine kinase inhibitors. Treatment with sutent involves a pill daily. The treatment will be continued as long as the patient is responding and does not have side effects. Patients will be reassessed at 4-6 week intervals. Your participation on this study will be completely voluntary. If you decide to withdraw from this study you can also discuss other treatment options with the study doctor.

Patient Inclusion Criteria:

• Age 18 or greater.
• Histopathologically-proven diagnosis of angiosarcoma, epithelioid sarcoma-like hemangioendothelioma or Kaposi’s sarcoma. Both HIV-Related and HIV-Unrelated Kaposi’s patients will be included in the trial.
• Disease not amenable to surgery, radiation, or combined modality treatment with curative intent.
• No more than 2 prior chemotherapy regimens for metastatic or unresectable disease. Patients may have received prior bevacizamab or other Tyrosine Kinase Inhibitors, excluding sunitinib. Treatment with bevacizamab or other Tyrosine Kinase Inhibitors will not be counted as prior chemotherapy regimens.
• Patient should have acceptable laboratory results.

PatientExclusionCriteria:

• Patients with a "currently active" second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered.
• No measurable disease present, either by visula inspection, CT, or MRI.
• Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, or cerebrovascular accident. or transient ischemic attack, or pulmonary embolism.
• Ongoing cardiac dysrhythmias, atrial fibrillation or prolongation of the QTc interval to > 450 msec for males of > 470 msec for females.
• Pregnancy or breastfeeding.
• Major surgery or radiation therapy within 4 weeks of starting the study treatment.
• Major bleeding within 4 weeks of starting the study treatment.
• History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases are allowed.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.