Status:
COMPLETED
Sutent and Radiation as Treatment for Limited Extent Metastatic Cancer
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Pfizer
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Zubrod Performance Scale 0-1
- Metastatic disease confirmed by biopsy or imaging
- 5 or fewer sites of metastatic disease on tumor staging (either CT chest/abdomen/pelvis plus bone scan or whole body FDG-PET)
- All tumors measure \< 6 cm
- Age \> 18
- Chemotherapy must be completed at least 2 weeks prior to radiation
- Signed informed consent
- Adequate bone marrow function, defined as follows;
- Platelets \> 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study
- Absolute neutrophil count (ANC) \> 1,800 cells/mm3 based on CBC/differential obtained within 2 weeks prior to registration on study
- Hemoglobin \> 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study (Note: The use of transfusion or other intervention to achieve Hgb \> 8.0 g/dt is acceptable.)
Exclusion
- Other coexisting malignancies or malignancies diagnosed within the previous 3 years with the exception of basal cell carcinoma, cervical carcinoma in situ, and other treated malignancies with no evidence of disease for at least 3 years
- Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary heart disease will be at the discretion of the attending physician.
- Patients with exudative, bloody, or cytologically malignant effusions are not eligible.
- Pregnancy or breast feeding (Women of child-bearing potential are eligible, but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
- Patients must have no uncontrolled active infection other than that not curable without treatment of their cancer.
- Prior radiation to target area
- Patient may not be receiving any other investigational agents during radiotherapy.
- Prior history of non-inducible bleeding (12/16/09).
- Requirement for continuation of anticoagulation (defined as Coumadin, lovenox, heparin, plavix, aspirin, NSAIDs or similar drugs) during treatment (12/16/09)
- Under 18 years of age
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00463060
Start Date
January 1 2007
End Date
July 1 2014
Last Update
July 18 2018
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029