Sunitinib in Soft Tissue Sarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00859456
First received: March 9, 2009
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Sarcoma, Soft Tissue
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Open-label, Non-randomized Trial of Sunitinib in Certain Subtypes of Soft Tissue Sarcomas

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Clinical response rate [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 17
Study Start Date: April 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunitinib
Drug administered PO daily for 42 days
Drug: Sunitinib
Taken daily PO for a 42 day cycle. This cycle is repeated at least twice.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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/µL 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859456

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Robert N Taub, MD, PhD Columbia University
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00859456     History of Changes
Other Study ID Numbers: AAAC2308
Study First Received: March 9, 2009
Last Updated: November 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014