Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02584309|
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : May 17, 2019
The purpose of this research study is to look at whether giving a drug called dexrazoxane with standard of care doxorubicin affects the progression of the disease. Dexrazoxane is often given at the same time as doxorubicin to help reduce the incidence and severity of disease of the heart muscle (which can be caused by doxorubicin).
In January 2019 Eli Lilly and Company reported that the results of the Phase 3 study of olaratumab (Lartruvo), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma, did not confirm the clinical benefit of olaratumab in combination with doxorubicin as compared to doxorubicin alone. Therefore olaratumab is being removed from the front line standard of care regimen. Amendment #9 was made to the protocol to reflect these changes to the standard of care treatment.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma, Soft Tissue Soft Tissue Sarcoma Undifferentiated Pleomorphic Sarcoma Leiomyosarcoma Liposarcoma Synovial Sarcoma Myxofibrosarcoma Angiosarcoma Fibrosarcoma Malignant Peripheral Nerve Sheath Tumor Epithelioid Sarcoma||Drug: Dexrazoxane Drug: Doxorubicin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Non-Inferiority Study of Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma|
|Actual Study Start Date :||February 22, 2016|
|Estimated Primary Completion Date :||October 31, 2023|
|Estimated Study Completion Date :||October 31, 2023|
Experimental: Arm 1: dexrazoxane & standard of care doxorubicin
Active Comparator: Arm 2: control (standard of care doxorubicin)
- Progression-free survival (PFS) (Arm 1 only) [ Time Frame: Up to 5 years ]
- PFS is defined as the time from randomization to the first occurrence of progression or death, whichever occurs first.
- If no event exists, the PFS will be censored at the last scheduled disease assessment on study.
- Progressive disease - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
- Cardiac-related mortality [ Time Frame: Up to 5 years ]Measured using CTCAE Version 4.0
- Incidence of heart failure or cardiomyopathy [ Time Frame: Up to 5 years ]Measured using CTCAE Version 4.0
- Ability of 3D echocardiogram to serve as an early marker of cardiac dysfunction by measuring echocardiogram parameters of left ventricular ejection fraction by comparing to 2D echocardiogram modified Simpson's biplane method of LVEF [ Time Frame: Day 1 of each odd numbered cycle (estimated median of 4 cycles) ]Left ventricular ejection fraction (LVEF) will be evaluated by 2D echocardiogram by modified Simpson's biplane method. Left ventricular systolic function will also be evaluated by 3D echocardiogram.
- Ability of 3D echocardiogram to serve as an early marker of cardiac dysfunction by measuring echocardiogram parameters of ventricular strain by comparing to 2D echocardiogram modified Simpson's biplane method of LVEF [ Time Frame: Day 1 of each odd numbered cycle (estimated median of 4 cycles) ]Left ventricular strain will be evaluated by 2D echocardiogram by evaluating the degree of shortening of the ventricular myocardium. Left ventricular strain will also be evaluated by 3D echocardiogram.
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): NCT02584309
|Contact: Brian A Van Tine, M.D., Ph.D.||email@example.com|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Brian A Van Tine, M.D., Ph.D. 314-747-8475 firstname.lastname@example.org|
|Principal Investigator: Brian A Van Tine, M.D., Ph.D.|
|Sub-Investigator: Ashley E Frith, M.D.|
|Sub-Investigator: Douglas R Adkins, M.D.|
|Sub-Investigator: Ronald J Krone, M.D.|
|Sub-Investigator: Justin Vader, M.D.|
|Sub-Investigator: George Heberton, M.D.|
|Sub-Investigator: Peter Oppelt, M.D.|
|Sub-Investigator: Caron Rigden, M.D.|
|Sub-Investigator: Angela Hirbe, M.D.|
|Sub-Investigator: Daniel Lenihan, M.D.|
|Principal Investigator:||Brian A Van Tine, M.D., Ph.D.||Washington University School of Medicine|