Sunitinib Malate in Treating Patients With Uterine Cervical Cancer That is Stage IVB, Recurrent, or Cannot Be Removed By Surgery
|ClinicalTrials.gov Identifier: NCT00389974|
Recruitment Status : Completed
First Posted : October 19, 2006
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cervical Adenocarcinoma Cervical Adenosquamous Cell Carcinoma Cervical Squamous Cell Carcinoma Recurrent Cervical Cancer Stage IVB Cervical Cancer||Drug: sunitinib malate||Phase 2|
I. To assess the efficacy (objective response rate) of sunitinib (sunitinib malate) given orally daily for 4 out of every 6 weeks in patients with unresectable, locally advanced or metastatic carcinoma of the cervix.
II. To assess the toxicity of sunitinib in patients with unresectable, locally advanced or metastatic carcinoma of the cervix.
III. To document time to progression, early objective progression rate, and, if objective responses are observed, response duration.
Patients receive sunitinib malate orally (PO) daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) or partial response (PR) may receive 2 courses after CR or PR is reached.
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 :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Sunitinib (SU11248; NSC 736511) an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Unresectable, Locally Advanced or Metastatic Cervical Carcinoma|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Experimental: Treatment (sunitinib malate)
Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.
Drug: sunitinib malate
- Objective Response Rate (PR or CR) [ Time Frame: Up to 2 years ]It is defined as per the Response Evaluation Criteria In Solid Tumors criteria for at least 4 weeks. The 95% confidence interval for response rate will be calculated.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389974
|National Cancer Institute of Canada Clinical Trials Group|
|Kingston, Ontario, Canada, K7L 3N6|
|Principal Investigator:||Helen Mackay||Canadian Cancer Trials Group|