Sunitinib in Treating Patients With Unresectable, Locally Advanced or Metastatic Cervical Cancer
RATIONALE: Sunitinib 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.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with unresectable, locally advanced or metastatic cervical cancer.
|Study Design:||Allocation: Non-Randomized
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; IND 74019), An Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Unresectable, Locally Advanced or Metastatic Cervical Carcinoma|
- Objective response (partial and complete) as measured by RECIST criteria for at least 4 weeks [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||January 2011|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Sunitinib 50 mg will be administered orally daily for 4 weeks out of every 6 weeks.
Drug: sunitinib malate
Sunitinib 50 mg will be administered orally daily for 4 weeks out of every 6 weeks
- Assess the efficacy, in terms of objective response rate, of sunitinib malate in patients with unresectable, locally advanced or metastatic carcinoma of the cervix.
- Assess the toxicity of this drug in these patients.
- Determine time to progression, early objective progression rate, objective response, and response duration in patients treated with this drug.
OUTLINE: This is a multicenter, nonrandomized study.
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients with responding disease receive 2 courses beyond complete response or stable partial response.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
|Canada, British Columbia|
|British Columbia Cancer Agency - Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|BCCA - Fraser Valley Cancer Centre|
|Surrey, British Columbia, Canada, V3V 1Z2|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|London Regional Cancer Program at London Health Sciences Centre|
|London, Ontario, Canada, N6A 4L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Edmond Odette Cancer Centre at Sunnybrook|
|Toronto, Ontario, Canada, M4N 3M5|
|McGill Cancer Centre at McGill University|
|Montreal, Quebec, Canada, H3G 1Y6|
|Allan Blair Cancer Centre at Pasqua Hospital|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Study Chair:||Helen J. Mackay, MD||Princess Margaret Hospital, Canada|