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A Phase II, Open-label, Non-randomized Trial of Sunitinib in Certain Subtypes of Soft Tissue Sarcomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Sarcoma, Soft Tissue

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Trial Information

A Phase II, Open-label, Non-randomized Trial of Sunitinib in Certain Subtypes of Soft Tissue Sarcomas


This is a Phase II, open label, nonrandomized single institution study to determine efficacy
and toxicity of sunitinib in certain subtypes of soft tissue sarcomas. Patients are
stratified according to sarcoma histology (angiosarcoma vs. hemangioendothelioma vs.
Kaposi's sarcoma).

The purpose of this study is to determine the clinical response rate (complete response and
partial response) in patients with metastatic, locally advanced, or locally recurrent
vascular soft tissue sarcoma treated with sunitinib. Secondary objectives will be to 1) To
determine 3 month and 6 month progression free survival, defined as patients that are alive
and without evidence of progression of disease on reassessment of disease after while being
treated; 2) To determine overall survival of patients treated with this regimen; 3) To
determine safety and tolerability of sunitinib in this patient population.


Inclusion Criteria:



- 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. Patients with HIV-Related Kaposi's
will be required to have a CD4 count >50 cells/┬ÁL and Viral Load < 50 copies/ml.
They will also need to be willing to take HAART. They can either have stable
Kaposi's on HAART for at least 3 months or have progression of their Kaposi's after
having been on HAART for at least 10 weeks.

- Not amenable to surgery, radiation, or combined modality treatment with curative
intent.

- Evidence of unidimensionally measurable disease by conventional radiographic
techniques. In patients with Kaposi's sarcoma, skin lesions at least 10 mm will be
considered measurable disease. Bone lesions, ascities, or lymphangitis of skin or
lung are not considered measurable.

- 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.

- Four weeks since prior chemotherapy, surgery or radiation therapy and resolution of
all toxic effects of any prior therapy, surgical procedure or radiation.

- ECOG performance status 0-2.

- Age 18 or greater.

Exclusion Criteria:

- 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. Patients who are
not considered to have a "currently active" malignancy if they have completed therapy
and are considered by their physician to be at less than 30% risk of relapse.

- No areas of measurable disease by 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. Medications that may prolong the QT
intervals should be discontinued or switched to another medication prior to starting
Sutent unless determined by the investigator to be absolutely necessary.

- Pregnancy or breastfeeding.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with the study participation or
study drug administration.

- Major surgery or radiation therapy within 4 weeks of starting the study treatment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response rate

Outcome Time Frame:

84 days

Safety Issue:

Yes

Principal Investigator

Robert N Taub, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAC2308

NCT ID:

NCT00859456

Start Date:

April 2007

Completion Date:

December 2013

Related Keywords:

  • Sarcoma, Soft Tissue
  • Sarcoma

Name

Location

Columbia University Medical Center New York, New York  10032