Clinical Trial: Sunitinib Malate in Treating Patients With Persistent or Recurrent Clear Cell Ovarian Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II Evaluation of SU11248 (Sunitinib Malate) (NSC #736511) in the Treatment of Persistent or Recurrent Clear Cell Ovarian Carcinoma

Brief Summary: This phase II trial studies the side effects of sunitinib malate and how well it works in treating patients with ovarian cancer that is persistent or has come back. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To evaluate the anti-tumor activity of SU11248 (sunitinib malate), a highly potent, selective tyrosine kinases inhibitor, in patients with persistent or recurrent clear cell ovarian carcinoma.

II. To examine the nature and degree of toxicity in this cohort of patients treated with this regimen.

SECONDARY OBJECTIVES:

I. To characterize the distribution of progression-free survival and overall survival for patients treated with SU11248 (sunitinib malate).

TERTIARY OBJECTIVES:

I. To determine the pre-cycle 1, pre-cycle 4 and off-treatment levels of pro-angiogenic proteins (e.g., angiogenin, soluble vascular cell adhesion molecule [VCAM]-I, basic fibroblast growth factor [bFGF], platelet-derived growth factor [PDGF], placental growth factor [PlGF], vascular endothelial growth factor [VEGF], and hypoxia-inducible factor [HIF]1alpha).

II. To identify changes in serum and plasma angiogenesis markers at baseline (pre-cycle 1), during treatment (cycle 4), and at progression in association with primary and secondary clinical endpoints associated with clinical response or progression-free survival.

OUTLINE:

Patients receive sunitinib malate orally (PO) once daily (QD) for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Objective tumor response rate (complete and partial response) [ Time Frame: Up to 5 years ]
  • Progression-free survival rate [ Time Frame: 6 months ]


Original Primary Outcome:

  • Objective tumor response rate (complete and partial response)
  • 6-month progression-free survival rate


Current Secondary Outcome:

  • Duration of overall survival [ Time Frame: From start of treatment to time of death or the date of last contact, assessed up to 5 years ]
    Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
  • Duration of progression-free survival [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ]
    Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
  • Incidence of adverse effects as assessed with the active version of the Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 5 years ]


Original Secondary Outcome:

  • Duration of progression-free survival and overall survival
  • Pro-angiogenic protein levels (e.g., angiogenin, soluble VCAM-I, bFGF, PDGF, PIGF, VEGF, and HIF1α) as measured at baseline, prior to course 4, and after completion of treatment
  • Association between changes in serum and plasma angiogenesis biomarkers and primary and secondary clinical endpoints (e.g., clinical response or progression-free survival)


Information By: National Cancer Institute (NCI)

Dates:
Date Received: September 17, 2009
Date Started: April 2010
Date Completion:
Last Updated: July 5, 2016
Last Verified: July 2016