Sunitinib Malate in Treating Patients With Persistent or Recurrent Clear Cell Ovarian Cancer
This phase II trial studies the side effects of sunitinib malate and how well it works in treating patients with persistent or recurrent ovarian cancer. 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.
Ovarian Clear Cell Cystadenocarcinoma
Recurrent Ovarian Epithelial Cancer
Drug: sunitinib malate
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of SU11248 (Sunitinib Malate) (NSC #736511) in the Treatment of Persistent or Recurrent Clear Cell Ovarian Carcinoma|
- Objective tumor response rate (complete and partial response) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Progression-free survival rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
- Change in pro-angiogenic protein levels [ Time Frame: Baseline to up to 5 years ] [ Designated as safety issue: No ]
- Changes in serum and plasma angiogenesis markers by enzyme-linked immunosorbent assays [ Time Frame: Baseline to up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (sunitinib malate)
Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Drug: sunitinib malate
Other Names:Other: laboratory biomarker analysis
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.
I. To characterize the distribution of progression-free survival and overall survival for patients treated with SU11248 (sunitinib malate).
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979992
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|Principal Investigator:||John Chan||NRG Oncology|