Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148109
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2005-09-02
Brief Title:
Trial of Cetuximab in Patients With Metastatic andor Locally Advanced Soft Tissue and Bony Sarcomas
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Phase II Trial of Cetuximab in Patients With Metastatic andor Locally Advanced Soft Tissue and Bony Sarcomas
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to explore how this cancer is affected by a new medication cetuximab Cetuximab is directed towards a protein called EGFR epidermal growth factor receptor that is found in some types of cancer Studies have shown that this drug can be beneficial in patients with colon cancer and has been approved by the US Food and Drug Administration FDA for this purpose The researchers are conducting a study to see if it is beneficial in patients with sarcoma
Detailed Description:
Sarcomas are mesenchymal malignancies that arise in the connective tissue throughout the body and afflict approximately 11000 people in the United States yearly Sarcomas are heterogeneous with well over 50 subtypes described The peak incidence is subtype-specific with certain sarcomas seen in children and young adults while other subtypes peak in late middle-age causing significant morbidity and mortality in young patients and productive adults
The precise etiology for most sarcomas remains unknown External radiation therapy is an established risk factor Other risk factors include occupational exposures to certain chemicals lymphedema and hereditary conditions such as neurofibromatosis and Li-Fraumeni syndrome Many sarcomas are associated with specific somatic genetic alterations For example some specific subtypes are associated with gene translocations causing aberrant fusion proteins including Ewing sarcoma EWS-FLI-1 synovial sarcoma SSX-SYT alveolar rhabdomyosarcoma PAX3-FHKR and myxoid liposarcomas TLS-CHOP These singular molecular alterations imply that some sarcomas are cytogenetically simple and may be more appropriate substrates for therapy targeted to a single molecular pathway
Sarcomas are commonly present as an asymptomatic mass or with local symptoms in an extremity or the retroperitoneum Although tumor size location and histologic subtype have been implicated as prognostic factors in sarcomas histologic grade remains the most important factor Tumor grade is based on the degree of cellularity differentiation pleomorphism necrosis and the number of mitoses Approximately 50-60 of patients with high grade soft tissue sarcoma will eventually have metastatic disease as compared to 5-10 of patients with low grade disease
Sarcomas spread hematogenously with the most common site of spread being the lung followed by liver bone and brain About 50 of patients with sarcoma eventually expire due to locally advanced or metastatic disease with a median survival of 8-12 months
The precise etiology for most sarcomas remains unknown External radiation therapy is an established risk factor Other risk factors include occupational exposures to certain chemicals lymphedema and hereditary conditions such as neurofibromatosis and Li-Fraumeni syndrome Many sarcomas are associated with specific somatic genetic alterations For example some specific subtypes are associated with gene translocations causing aberrant fusion proteins including Ewing sarcoma EWS-FLI-1 synovial sarcoma SSX-SYT alveolar rhabdomyosarcoma PAX3-FHKR and myxoid liposarcomas TLS-CHOP These singular molecular alterations imply that some sarcomas are cytogenetically simple and may be more appropriate substrates for therapy targeted to a single molecular pathway
Sarcomas are commonly present as an asymptomatic mass or with local symptoms in an extremity or the retroperitoneum Although tumor size location and histologic subtype have been implicated as prognostic factors in sarcomas histologic grade remains the most important factor Tumor grade is based on the degree of cellularity differentiation pleomorphism necrosis and the number of mitoses Approximately 50-60 of patients with high grade soft tissue sarcoma will eventually have metastatic disease as compared to 5-10 of patients with low grade disease
Sarcomas spread hematogenously with the most common site of spread being the lung followed by liver bone and brain About 50 of patients with sarcoma eventually expire due to locally advanced or metastatic disease with a median survival of 8-12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Legacy IRB 2005-0072 | OTHER | University of Michigan Medical IRB | None |