Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
Endometrial Endometrioid Adenocarcinoma
Endometrial Serous Adenocarcinoma
Recurrent Uterine Corpus Carcinoma
Stage IVA Uterine Corpus Cancer
Stage IVB Uterine Corpus Cancer
Uterine Corpus Carcinosarcoma
Drug: Sunitinib Malate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Sunitinib Malate in Recurrent or Metastatic Endometrial Carcinoma|
- Objective response rate, defined as the rate of complete or partial response as defined by the Response Evaluation Criteria for Solid Tumors [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
- Incidence of adverse effects assessed by Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 7 years ] [ Designated as safety issue: Yes ]Adverse events will be summarized in tabular form, describing all adverse events, and sub-tables describing all attributable (possibly, probably or definitely related) and all serious (grade 3 or higher) adverse events will also be constructed.
- Incidence of prolonged stable disease (i.e., best response of stable disease that is maintained for at least 6 months) [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]Estimated using the Kaplan-Meier method.
- Time to progression [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (sunitinib malate)
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Sunitinib Malate
I. To assess the objective response rate of recurrent or metastatic endometrial cancer to sunitinib (sunitinib malate).
II. To assess the frequency of prolonged stable disease (as defined by percentage [%] of patients alive and free from progressive disease at 6 months) in patients with recurrent or metastatic endometrial cancer treated with sunitinib.
I. To assess time-to- progression, median overall survival, and rate of one-year survival in patients with recurrent or metastatic endometrial cancer treated with sunitinib.
II. To assess the toxicity associated with sunitinib in patients with recurrent or metastatic endometrial cancer.
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up at 4 weeks and then every 3 months until relapse.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478426
Show 29 Study Locations
|Principal Investigator:||Amit Oza||University Health Network-Princess Margaret Hospital|