Sunitinib Malate in Treating Patients With Cervical Cancer That is Stage IVB, Recurrent, or Cannot Be Removed By Surgery
This phase II trial studies the side effects and how well sunitinib malate works in treating patients with cervical cancer which cannot be cured by standard therapy. Sunitinib malate may stop the growth of cervical cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Cervical Adenosquamous Cell Carcinoma
Cervical Squamous Cell Carcinoma
Recurrent Cervical Cancer
Stage IVB Cervical Cancer
Drug: sunitinib malate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Objective response rate (PR or CR) defined as per the Response Evaluation Criteria In Solid Tumors criteria for at least 4 weeks [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]The 95% confidence interval for response rate will be calculated. The median and range of the duration of response will be assessed.
|Study Start Date:||January 2007|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389974
|National Cancer Institute of Canada Clinical Trials Group|
|Kingston, Ontario, Canada, K7L 3N6|
|Principal Investigator:||Helen Mackay||NCIC Clinical Trials Group|