Clinical Trial: Sunitinib or Cediranib for Alveolar Soft Part Sarcoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase II Trial In Which Patients With Metastatic Alveolar Soft Part Sarcoma Are Randomized to Either Sunitinib or Cediranib Monotherapy, With Cross-Over at Disease Progr
Brief Summary:
Background:
- Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor accounting for less than 1% of soft tissue sarcomas. There is no effective systemic treatment for patients with metastatic ASPS. Little is known with regards to relevant molecular markers as potential therapeutic targets.
- Cediranib (AZD2171) and sunitinib (SU011248), oral small molecule inhibitors of VEGF receptor tyrosine kinases, are showing preliminary evidence of activity in patients with ASPS.
Objectives:
- Part I: Determine the objective response rate (ORR) of single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS.
- Part II: Determine the ORR of cediranib in patients who progress on the sunitinib arm, and determine the ORR of sunitinib in patients who progress on the cediranib arm.
- Determine the progression-free survival (PFS) at 24 weeks for single-agent cediranib and
single-agent sunitinib malate in patients with advanced ASPS.
Eligibility:
- Patients aged greater than or equal to 16 years with histologically or cytologically confirmed metastatic ASPS.
- Patients must show evidence of objective disease progression per RECIST 1 on scans within the 3-month period immediately preceding enrollment. Both scans used to determine disease progression should have been obtained within this 6-month period.
- Patients with newly diagnosed, unresectab