Recurrent Adult Soft Tissue Sarcoma Clinical Trial
Official title:
A Multicenter Phase II Study of Sorafenib (BAY43-9006) in Non-GIST Sarcomas
This phase II trial is studying how well sorafenib works in treating patients with metastatic, locally advanced, or recurrent sarcoma. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PRIMARY OBJECTIVES:
I. The primary endpoint is the response rate (CR+PR) for each stratum of sarcoma patients
treated with sorafenib as defined by RECIST.
SECONDARY OBJECTIVES:
I. Progression-free survival (defined as CR + PR + SD, assessed at 3 months or 6 months).
II. Overall survival. III. Pharmacokinetics of sorafenib in this patient population (all
sites will participate).
IV. Frequency of B-raf mutations in the patients' sarcomas treated as part of this study and
correlation with response or resistance to sorafenib (all sites will participate).
V. Ras-raf kinase pathway activation in pre-treatment existing tumor specimens (paraffin
section immunohistochemistry; all sites will participate).
VI. At MSKCC only: Pre and post treatment specimen changes in downstream events of ras
signaling, specifically inhibition of ERK phosphorylation. Only patients with angiosarcoma
and MPNST will undergo biopsy (up to 10 patients).
VII. At MSKCC only: Circulating Endothelial Cells (CECs), VE-cadherin levels, and soluble
protein levels (VEGF, bFGF, endostatin) as a measures of angiogenesis before and after
starting sorafenib therapy.
OUTLINE: This is an open-label, non-randomized, multicenter study. Patients are stratified
according to sarcoma histology (angiosarcoma vs malignant peripheral nerve sheath tumor vs
leiomyosarcoma [closed to accrual as of 11/29/06] vs high-grade undifferentiated pleomorphic
sarcoma [i.e., malignant fibrous histiocytoma (including myxofibrosarcoma)(closed to accrual
as of 11/29/06)] vs synovial sarcoma (closed to accrual as of 11/29/06) vs all other types
of sarcoma).
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed at 4 weeks.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01206140 -
Selumetinib With or Without Temsirolimus in Treating Patients With Metastatic, Recurrent, or Locally Advanced Soft Tissue Sarcoma That Cannot Be Removed By Surgery
|
Phase 2 | |
Completed |
NCT01222715 -
Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma
|
Phase 2 | |
Completed |
NCT01553539 -
Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery
|
Phase 2 | |
Completed |
NCT00098579 -
Doxorubicin Hydrochloride and Alvocidib in Treating Patients With Metastatic or Recurrent Sarcoma That Cannot Be Removed By Surgery
|
Phase 1 | |
Completed |
NCT00004241 -
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma
|
Phase 1 | |
Completed |
NCT01462630 -
Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma
|
Phase 2 | |
Completed |
NCT01016015 -
Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma
|
Phase 2 | |
Terminated |
NCT00087191 -
EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
|
N/A | |
Completed |
NCT00084630 -
Imatinib Mesylate in Treating Patients With Locally Recurrent or Metastatic Dermatofibrosarcoma Protuberans
|
Phase 2 | |
Completed |
NCT01782313 -
A Phase II Study of Tivozanib in Patients With Metastatic and Non-resectable Soft Tissue Sarcomas
|
Phase 2 | |
Completed |
NCT02357810 -
Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas
|
Phase 2 | |
Terminated |
NCT00233948 -
Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01552434 -
Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease
|
Phase 1 | |
Completed |
NCT00919269 -
Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma
|
||
Completed |
NCT01532687 -
Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma
|
Phase 2 | |
Completed |
NCT01154452 -
Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma
|
Phase 1/Phase 2 | |
Completed |
NCT00937495 -
Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma
|
Phase 2 | |
Completed |
NCT00720174 -
Cixutumumab and Doxorubicin Hydrochloride in Treating Patients With Unresectable, Locally Advanced, or Metastatic Soft Tissue Sarcoma
|
Phase 1 | |
Completed |
NCT00330421 -
Sorafenib in Treating Patients With Soft Tissue Sarcomas (Extremity Sarcoma Closed to Entry as of 5/30/07)
|
Phase 2 | |
Completed |
NCT00087074 -
CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor
|
Phase 2 |