A Phase II Study of Oral Cyclophosphamide and Sirolimus (OCR) in Advanced Sarcoma (OCR)
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|ClinicalTrials.gov Identifier: NCT00743509|
Recruitment Status : Completed
First Posted : August 29, 2008
Results First Posted : May 22, 2013
Last Update Posted : September 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteosarcoma||Drug: Cyclophosphamide and Sirolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Oral Cyclophosphamide and Sirolimus (OCR) in Advanced Sarcoma|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||September 2012|
Experimental: Oral Cyclophosphamide and Sirolimus (OCR)
Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.
Drug: Cyclophosphamide and Sirolimus
The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.
Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously
Other Name: Sirolimus (rapamycin, Rapamune)
- Number of Patients Alive Without Disease Progression [ Time Frame: 6 months ]Patients who were evaluable for response to therapy, alive and without evidence of sarcoma disease progression. Target lesions followed were lesions that had progressed by World Health Organization (WHO) criteria. Disease progression is defined as a greater than or equal to 25% increase in the sum of the product of target lesions, or unequivocal progression of non-target lesions or the appearance of new tumor lesions >10mm.
- Median Overall Survival Time [ Time Frame: 48 weeks ]Median overall duration of survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743509
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Scott Schuetze, MD, PhD||University of Michigan Cancer Center|