Study on Sunitinib or Cediranib for Treating Alveolar Soft Part Sarcoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01391962

Provider View

This clinical trial is testing two drugs, Sunitinib and Cediranib, to see if they can help treat a rare type of cancer called Alveolar Soft Part Sarcoma (ASPS), which currently has no effective treatment for cases that have spread.

Patient Parameters

Program Overview

Alveolar Soft Part Sarcoma (ASPS) is a rare cancer that affects soft tissues and is known for being highly vascular, meaning it has many blood vessels. This study is exploring two drugs, Sunitinib and Cediranib, which have shown early promise in treating ASPS. The trial aims to find out how well each drug works on its own and if switching to the other drug helps when the first one stops working. The study will also look at how long patients can live without the cancer getting worse when taking these drugs.

Description

This study is divided into two parts. In Part I, patients with advanced ASPS will be randomly assigned to take either Cediranib or Sunitinib daily in 28-day cycles. The goal is to see how many patients experience a reduction in their cancer. In Part II, if the cancer progresses, patients will switch to the other drug after a two-week break. The study will use imaging tests to monitor the cancer every two cycles. Initially, 10 patients will be enrolled in each group. If at least two patients respond to the treatment, more patients will be added to reach a total of 22 in each group.

Eligibility Criteria

Inclusion Criteria

  • Must be 16 years or older with confirmed metastatic Alveolar Soft Part Sarcoma (ASPS) that cannot be cured by surgery.
  • Must show evidence of cancer progression on scans within the last 6 months.
  • Must have measurable cancer that can be tracked using standard criteria.
  • Must have completed any previous cancer treatments at least 4 weeks before joining the study and recovered from any side effects.
  • Must have normal organ and blood function as determined by specific tests.
  • Must not have taken any VEGF receptor tyrosine kinase inhibitors before, but previous treatment with bevacizumab is allowed.
  • Must be able to swallow tablets and capsules.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 2 months after.

Exclusion Criteria

  • Must not have taken any VEGF receptor tyrosine kinase inhibitors before.
  • Must not be receiving any other investigational drugs.
  • Must not have had major surgery within 4 weeks before starting the study.
  • Must not have a history of long QT syndrome or be taking medications that prolong the QT interval.
  • Must not have uncontrolled health conditions like high blood pressure, heart failure, or infections.
  • Must not have conditions that affect the ability to swallow or absorb the drug.
  • Must not have serious wounds or ulcers, or have had certain surgeries or strokes within the past year.
  • Must not have significant protein in the urine.
  • HIV-positive patients on antiretroviral therapy are not eligible due to potential drug interactions.

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