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
Detailed 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:
Status Update: Patients enrolled after Amendment G (version dated 08/16/2013), will be
evaluated and compared to the first 13 patients by the study statistician and the Principal
Investigator. Patients with newly diagnosed ASPS with clinical evidence of disease progression will also be assessed separately.
- Patients ag
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome:
- Determine the objective response rate (ORR) of single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS. [ Time Frame: 24 weeks ]
- Determine the ORR of cediranib in patients who progress on thesunitinib arm, and determine the ORR of sunitinib in patients whoprogress on the cediranib arm [ Time Frame: 24 weeks ]
Original Primary Outcome: Determine the objective response rate (ORR) of single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS. [ Time Frame: 3 years ]
Current Secondary Outcome:
- Determine the progression-free survival (PFS) at 24 weeks for single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS [ Time Frame: 4 and 6 months ]
- Perform pharmacokinetic analysis for cediranib [ Time Frame: At the time of progression ]
Original Secondary Outcome: Determine the progression-free survival (PFS) at 6 months in Part I and in Part II of the study for single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS. [ Time Frame: 3 years ]
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: July 9, 2011
Date Started: June 17, 2011
Date Completion: April 28, 2018
Last Updated: May 12, 2017
Last Verified: April 21, 2017