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Sutent and Radiation as Treatment for Limited Extent Metastatic Cancer
This study is currently recruiting participants.
Verified by Mount Sinai School of Medicine, June 2008
Sponsors and Collaborators: Mount Sinai School of Medicine
Pfizer
Information provided by: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00463060
  Purpose

Cancer is the second leading cause of death in the United States, with approximately 90% of deaths resulting from patients with metastatic spread. Save for notable exceptions such as testicular cancer, chemotherapy alone cannot cure patients with metastases. Some patients with limited metastatic deposits (most commonly colon cancer spread to the liver) can be cured with surgery followed by chemotherapy. Therefore, some patients with metastases should be considered for aggressive local therapy (surgery and/or radiation).

Even though chemotherapy has improved significantly, patients treated with conventional chemotherapy and/or biologically targeted therapy are not cured of their disease. For the most common types of cancer, chemotherapy alone can shrink or stabilize tumors for an average of 6 months before the tumors regrow. Both chemotherapy and biologically targeted therapy have major limitations preventing cure of these patients.

Radiation therapy is an effective modality of treating cancer. Until recently, radiation for metastases was used only to relieve symptoms resulting from local tumor growth. Technological advances, including stereotactic radiotherapy, allow for radiation to be more precisely delivered to the tumor while sparing nearby normal organs. Stereotactic radiotherapy can completely eradicate local tumors with minimal side effects. Stereotactic radiotherapy has never been combined with drug therapy. Sutent is a new F.D.A. approved cancer therapy that targets tumor blood vessels. It is effective against two types of cancer that rarely respond to chemotherapy (GI stromal tumors and kidney cancer). We propose combining biologically targeted drug therapy with physically targeted stereotactic radiotherapy. Our goal is to determine if this is a safe regimen and the best method of combining these treatments. Ultimately, our goal is to cure some patients with previously incurable metastatic cancer with this combination.


Condition Intervention Phase
Cancer
Drug: sunitinib malate (Sutent)
Procedure: radiotherapy
Phase I
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Sunitinib Sunitinib malate Malic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I/II Study of Stereotactic Radiation Therapy and Concurrent and Adjuvant Sutent (SU11248) as Treatment for Oligometastatic Disease

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • survival

Secondary Outcome Measures:
  • toxicity
  • quality of life
  • local control

Estimated Enrollment: 65
Study Start Date: January 2007
  Eligibility

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

Inclusion Criteria:

  • Age 18 years or older
  • Histologically or cytologically confirmed diagnosis of metastatic cancer
  • No prior RT to currently involved sites
  • Informed consent
  • ECOG performance status < 2
  • Intact organ and bone marrow function
  • Obtained informed consent

Exclusion Criteria:

  • Under 18 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463060

Contacts
Contact: Johnny Kao, MD 212-241-7503 Johnny.kao@mountsinai.org
Contact: Stuart Packer, MD 212-241-8617 stuart.packer@Mountsinai.org

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Johnny Kao, MD     212-241-7503     Johnny.kao@mountsinai.org    
Contact: Stuart Packer     212-241-8617     stuart.packer@Mountsinai.org    
Principal Investigator: Johnny Kao, MD            
Sponsors and Collaborators
Mount Sinai School of Medicine
Pfizer
Investigators
Principal Investigator: Johnny Kao, MD Mount Sinai School of Medicine
  More Information

Study ID Numbers: GCO 06-0906
Study First Received: April 18, 2007
Last Updated: June 17, 2008
ClinicalTrials.gov Identifier: NCT00463060  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Sunitinib
Neoplasm Metastasis

Additional relevant MeSH terms:
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009