Sunitinib Malate in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
|ClinicalTrials.gov Identifier: NCT00388037|
Recruitment Status : Completed
First Posted : October 13, 2006
Results First Posted : January 15, 2015
Last Update Posted : January 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Fallopian Tube Cancer Recurrent Ovarian Epithelial Cancer Recurrent Primary Peritoneal Cavity Cancer Stage IIIA Fallopian Tube Cancer Stage IIIA Ovarian Epithelial Cancer Stage IIIA Primary Peritoneal Cavity Cancer Stage IIIB Fallopian Tube Cancer Stage IIIB Ovarian Epithelial Cancer Stage IIIB Primary Peritoneal Cavity Cancer Stage IIIC Fallopian Tube Cancer Stage IIIC Ovarian Epithelial Cancer Stage IIIC Primary Peritoneal Cavity Cancer Stage IV Fallopian Tube Cancer Stage IV Ovarian Epithelial Cancer Stage IV Primary Peritoneal Cavity Cancer||Drug: sunitinib malate Other: laboratory biomarker analysis||Phase 2|
I. To assess the efficacy (response rate) of sunitinib (sunitinib malate) given orally daily in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
II. To assess the toxicity of sunitinib in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
III. To document cancer antigen 125 (CA125) response rate, early objective progression rate, and, if objective responses are observed, response duration.
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Sunitinib (SU11248; NSC 736511) in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: Treatment (sunitinib malate)
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: sunitinib malate
Other Names:Other: laboratory biomarker analysis
- Objective Response (Partial Response or Complete Response) as Per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria [ Time Frame: Up to 3 years ]Partial response is defined as a 30% decrease in the sum of the longest diameters of the target lesion maintained for at least 4 weeks; complete response is defined as complete disappearance of disease and cancer related symptoms maintained for at least 4 weeks. The 95% confidence interval for response rate will be calculated. The median and range of the duration of response will be assessed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388037
|National Cancer Institute of Canada Clinical Trials Group|
|Kingston, Ontario, Canada, K7L 3N6|
|Principal Investigator:||James Biagi||Canadian Cancer Trials Group|