Sunitinib or Cediranib for Alveolar Soft Part Sarcoma
- Alveolar soft part sarcoma is a rare type of tumor that has a lot of blood vessel growth. Cediranib and sunitinib are two cancer treatment drugs that work by blocking the growth of new blood vessels. This may help to stop tumor growth. Some patients with alveolar soft part sarcoma treated with cediranib or sunitinib had tumors that either decreased in size or remained stable without growth for a long time. More research is needed to see whether these drugs can be approved as a standard treatment for alveolar soft part sarcoma.
- To test the safety and effectiveness of cediranib and sunitinib to treat alveolar soft part sarcoma.
- To determine the objective response rate of cediranib and sunitinib in patients with alveolar soft part sarcoma.
- Individuals at least 16 years of age who have alveolar soft part sarcoma.
- Individuals who have not received prior cediranib or sunitinib.
- All participants will be screened with a physical exam and medical history. They will also have blood and urine tests, tumor imaging studies, and biopsies.
- Participants will be divided into two groups: one group will start with cediranib and the other will start with sunitinib.
- During Part I of the study, participants will take cediranib or sunitinib by mouth once a day. They will continue this routine every day for 28 days (one cycle of treatment). They will stop taking the drug if the side effects become too severe or the tumor starts growing again.
- Participants will not have any cancer treatment for 2 weeks before starting Part II.
- During Part II, participants will receive the other study drug (cediranib or sunitinib). However, if one of the drugs is not effective or its side effects are too severe, participants will not receive the drug and will stop being in the study.
- Participants will be monitored with frequent blood and urine tests. They will also have tumor imaging studies and other tests.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Determine the objective response rate (ORR) of single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Part I
Patients will be randomized to received cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles.Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 patients has a clinical response, then no further patients will be accrued.
30 mg orally, once daily, in 28 day cycles
Active Comparator: Part II
At the time of disease progression (documented by RECIST 1.1) patients will cross over to the other treatment arm after a 2-week wash-out period.
37.5 mg orally, once a day, in 28-day cycles
- 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.
- 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.
-Evaluate gene expression in tumor biopsies obtained at baseline and after treatment (at the Clinical Center, NCI only).
- Patients age 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 at least 6 weeks apart within the 3-month period immediately preceding enrollment.
- 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.
- 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.
-For patients enrolled at the Clinical Center, NCI only, optional tumor biopsies will be performed at baseline and once during cycle 1 between days 3 and 5.
|Contact: Deborah E Allen, R.N.||(301) firstname.lastname@example.org|
|Contact: Shivaani Kummar, M.D.||(301) email@example.com|
|United States, California|
|Santa Monica Oncology Center||Recruiting|
|Santa Monica, California, United States, 90403|
|Contact: Shivaani Kummar, M.D. 301-435-5402 firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030-4096|
|Principal Investigator:||Shivaani Kummar, M.D.||National Cancer Institute (NCI)|