Sunitinib or Cediranib for Alveolar Soft Part Sarcoma
Status:
Active, not recruiting
Trial end date:
2022-12-15
Target enrollment:
Participant gender:
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, unresectable, measurable, metastatic ASPS who show
clinical evidence of disease progression will be eligible.
- Patients must not have received treatment with any VEGF receptor tyrosine kinase
inhibitor (e.g., cediranib, sunitinib, pazopanib, sorafenib); however, prior treatment
with bevacizumab is allowed.
Design:
- Part I: Patients will be randomized to receive cediranib (30 mg) or sunitinib malate
(37.5 mg) orally, once a day in 28-day cycles.
- Part II: At the time of disease progression, patients will cross over to the other
treatment arm after a 2-week wash-out period.
- Appropriate anatomic imaging studies will be performed at baseline and every 2 cycles
for restaging.
- The study will be conducted using an optimal two-stage design to rule out an
unacceptably low 15% clinical response rate (PR+CR) in favor of a modestly high response
rate of 40%.
The study will initially enroll 10 evaluable patients in each arm. If 0 or 1 of the 10
patients has a clinical response, then no further patients will be accrued. If 2 or more the
first 10 patients have a response, then accrual continues to a total of 22 patients in each
arm.