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Sunitinib or Cediranib for Alveolar Soft Part Sarcoma

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Disease Information

Descriptive Information
Brief Title † Sunitinib or Cediranib for Alveolar Soft Part Sarcoma
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 Progression
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, 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.
Detailed Description 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 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.
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Determine the objective response rate (ORR) of single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS.
Secondary Outcome Measure † Determine the progression-free survival (PFS) at 24 weeks for single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS
Condition † Sarcoma, Alveolar Soft Part
Intervention † DrugCediranib
Study Arms / Comparison Groups 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.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 70
Start Date † June 17, 2011
Completion Date April 28, 2018
Primary Completion Date April 28, 2018
Eligibility Criteria † - INCLUSION CRITERIA: 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 must have histologically confirmed metastatic alveolar soft part sarcoma that is not curable by surgery. Diagnosis of malignancy must be confirmed by the department of pathology at the institution where the patient is enrolled prior to patient enrollment. - Patients must show evidence of objective disease progression per RECIST 1 on scans within the 6 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, metastatic, and measurable ASPS who show clinical evidence of disease progression (including history and increasing physical symptoms) will also be eligible. On-study documentation will include a physician s rationale that supports evidence of clinical disease progression (i.e., increasing tumor pain). - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan. - Any prior therapy must have been completed greater than or equal to 4 weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels from prior toxicity. Patients should be at least 6 weeks out from nitrosoureas and mitomycin C. Prior radiation should have been completed greater than or equal to 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels. Patients who have had prior monoclonal antibody therapy must have completed that therapy at least 3 half-lives of the antibody or 6 weeks ago. Patients who have received more than a cumulative dose of 350 mg/m(2) of doxorubicin may be enrolled at the discretion of the Coordinating Center PI after consultation with a cardiologist and if screening echocardiogram is normal. - Patients must be greater than or equal to 2 weeks since any investigational agent administered as part of a Phase 0 study (also referred to as an early Phase I study or pre-Phase I study where a sub-therapeutic dose of drug is administered) at the Coordinating Center PI s discretion, and should have recovered to eligibility levels from any toxicities. - Patients with no prior therapy are eligible, provided they have metastatic disease that is not curable by surgery. - Age greater than or equal to 16 years. Patients age 16-17 years are eligible only if they have a BSA greater than or equal to 1.7 m(2) or weigh greater than or equal to 60 kg. - ECOG performance status less than or equal to 2. - Life expectancy of greater than 3 months. - Patients must have normal organ and marrow function as defined below: - leukocytes greater than or equal to 3,000/mcL - absolute neutrophil count greater than or equal to 1,500/mcL - platelets greater than or equal to 100,000/mcL - hemoglobin greater than or equal to 9 g/dL - total serum bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) less than or equal to 2.5 times institutional upper limit of normal - creatinine within normal institutional limits OR - creatinine clearance greater than or equal to 60 mL/min for patients with creatinine levels above institutional normal - QTc 1 g. Patients with
Gender All
Ages 16 Years - 120 Years
Accepts Healthy Volunteers No
Contacts †† Nancy Moore, R.N., (301) 402-5640, nancy.moore@nih.gov
Location Countries † Canada
Administrative Information
NCT ID † NCT01391962
Organization ID 110200
Secondary IDs †† 11-C-0200
Responsible Party Sponsor
Study Sponsor † National Cancer Institute (NCI)
Collaborators ††
Investigators † Principal Investigator: Alice P Chen, M.D., National Cancer Institute (NCI)
Information Provided By
Verification Date April 21, 2017
First Received Date † July 9, 2011
Last Updated Date May 31, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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