Cixutumumab and Doxorubicin Hydrochloride in Treating Patients With Unresectable, Locally Advanced, or Metastatic Soft Tissue Sarcoma
|ClinicalTrials.gov Identifier: NCT00720174|
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : May 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Adult Angiosarcoma Adult Desmoplastic Small Round Cell Tumor Adult Epithelioid Sarcoma Adult Extraskeletal Myxoid Chondrosarcoma Adult Extraskeletal Osteosarcoma Adult Fibrosarcoma Adult Leiomyosarcoma Adult Liposarcoma Adult Malignant Mesenchymoma Adult Malignant Peripheral Nerve Sheath Tumor Adult Rhabdomyosarcoma Adult Synovial Sarcoma Adult Undifferentiated High Grade Pleomorphic Sarcoma of Bone Childhood Angiosarcoma Childhood Desmoplastic Small Round Cell Tumor Childhood Epithelioid Sarcoma Childhood Fibrosarcoma Childhood Leiomyosarcoma Childhood Liposarcoma Childhood Malignant Mesenchymoma Childhood Malignant Peripheral Nerve Sheath Tumor Childhood Pleomorphic Rhabdomyosarcoma Childhood Rhabdomyosarcoma With Mixed Embryonal and Alveolar Features Childhood Synovial Sarcoma Dermatofibrosarcoma Protuberans Malignant Adult Hemangiopericytoma Malignant Childhood Hemangiopericytoma Metastatic Childhood Soft Tissue Sarcoma Previously Treated Childhood Rhabdomyosarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Childhood Rhabdomyosarcoma Recurrent Childhood Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma Untreated Childhood Rhabdomyosarcoma||Biological: Cixutumumab Drug: Doxorubicin Hydrochloride Other: Laboratory Biomarker Analysis||Phase 1|
I. To collect safety data about the combination of doxorubicin and Cixitumumab and determine if they can be combined with acceptable toxicity at full doses.
I. To assess the confirmed response rate (CR + PR as defined by RECIST) of patients with locally advanced or metastatic soft tissue sarcoma when treated with combination doxorubicin and Cixitumumab II. To assess the 3 and 6 month progression free survival rate of patients treated with doxorubicin and Cixitumumab.
III. To assess the progression free survival and overall survival of patients treated with doxorubicin and Cixitumumab.
IV. To evaluate changes in left ventricular ejection fraction assessed by MUGA scan after 2, 4 and 6 cycles of therapy compared to baseline.
OUTLINE: This is a multicenter, dose-escalation study of anti-IGF-1R recombinant monoclonal antibody cixutumumab.
Patients receive cixutumumab intravenously (IV) over 1 hour on days 1, 8, and 15 and doxorubicin hydrochloride IV continuously over 44-52 hours beginning on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue to receive cixutumumab in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Doxorubicin and A12 in Advanced Soft Tissue Sarcoma|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||January 2013|
Experimental: Treatment (cixutumumab and doxorubicin hydrochloride)
Patients receive cixutumumab IV over 1 hour on days 1, 8, and 15 and doxorubicin hydrochloride IV continuously over 44-52 hours beginning on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue to receive cixutumumab in the absence of disease progression or unacceptable toxicity.
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
- Maximally tolerated dose (MTD) of cixitumumab when administered in a combination regimen with fixed dose doxorubicin hydrochloride, in patients with locally advanced or metastatic soft tissue sarcoma [ Time Frame: Up to 2 courses of treatment ]The MTD is defined as the dose of Cixitumumab that induces dose-limiting toxicity (DLT) in no more than 20% of patients.
- Changes in cardiac function as measured by MUGA scans of the left ventricular ejection fraction [ Time Frame: Baseline to 6 courses of treatment ]
- Confirmed response rate (CR + PR) for comparison with doxorubicin treatment in similar historical patient populations [ Time Frame: Up to 6 months ]The mean response probability with 90% credible interval will be reported for those patients treated at the dose of cixitumumab found to be the MTD.
- Overall survival [ Time Frame: Until death due to any cause, or loss to follow-up, assessed up to 6 months ]Will be estimated using the product-limit method Kaplan and Meier. With point-wise estimates for the 3 and 6-month survival proportions reported with 95% confidence intervals using Greenwood's formula for calculation of the variance.
- Progression-free survival [ Time Frame: Until documented disease progression or death or loss-to-follow-up, assessed up to 6 months ]Will be estimated using the product-limit method Kaplan and Meier. With point-wise estimates for the 3 and 6-month progression-free survival proportions reported with 95% confidence intervals using Greenwood's formula for calculation of the variance.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720174
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|Decatur Memorial Hospital|
|Decatur, Illinois, United States, 62526|
|NorthShore University HealthSystem-Evanston Hospital|
|Evanston, Illinois, United States, 60201|
|Ingalls Memorial Hospital|
|Harvey, Illinois, United States, 60426|
|Joliet Oncology-Hematology Associates Limited|
|Joliet, Illinois, United States, 60435|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Peoria, Illinois, United States, 61615|
|Central Illinois Hematology Oncology Center|
|Springfield, Illinois, United States, 62702|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology Inc-Parkview|
|Fort Wayne, Indiana, United States, 46845|
|United States, Maryland|
|University of Maryland/Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|United States, Missouri|
|Mercy Hospital Saint Louis|
|Saint Louis, Missouri, United States, 63141|
|United States, Wisconsin|
|Froedtert and the Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Rashmi Chugh||University of Chicago Comprehensive Cancer Center|