Phase II Study of Doxorubicin and Avastin® in Sarcoma.
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|ClinicalTrials.gov Identifier: NCT00755261|
Recruitment Status : Terminated (The study has been terminated due to low accrual.)
First Posted : September 18, 2008
Results First Posted : May 8, 2015
Last Update Posted : May 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma Soft Tissue Sarcoma||Drug: Avastin Drug: Doxorubicin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Doxorubicin and Avastin® for Patients With Advanced Soft-tissue Sarcomas.|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||November 2010|
Experimental: Avastin and Doxorubicin
Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.
Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.
Other Name: bevacizumab
The Day 1 6- hour continuous IV infusion must be done through a central venous catheter.
Other Name: Adriamycin
- RECIST [ Time Frame: 6 month PFS ]Study was terminated because of low accrual.
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): NCT00755261
|United States, Maryland|
|Johns Hopkins SKCCC|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Katherine A Thornton, MD||Johns Hopkins SKCCC|