A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours
- Conditions
- Advanced Rare Tumours
- Interventions
- Registration Number
- NCT01396408
- Lead Sponsor
- Canadian Cancer Trials Group
- Brief Summary
This research is being done because there is no treatment that will cure this type of cancer. Although some types of chemotherapy can cause this cancer to shrink for a time, better options are needed.
- Detailed Description
The purpose of this study is to find out what effects the study drugs - sunitinib or temsirolimus - will have on this type of cancer. The study will begin by finding out if sunitinib can shrink the cancer. If sunitinib does not work, temsirolimus will be tested next.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 137
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sunitinib Sunitinib - Temsirolimus Temsirolimus -
- Primary Outcome Measures
Name Time Method Objective Response Every 4 weeks Objective response as assessed by RECIST version 1.1 criteria as a 30% decrease in the sum of the longest diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response), also maintained for at least 4 weeks. Early progression is defined as progressive disease at or prior to the first assessment. The 95% confidence interval for response rate will be calculated. The median and range of the duration of response will be assessed
- Secondary Outcome Measures
Name Time Method Efficacy Outcomes 48 months * Response duration: median and range
* Time to progression: median, 95% confidence interval
* Progression free survival: median, 95% confidence interval
* Overall survival: median, 95% confidence interval
* Comparison of the time to first and second progression for patients who receive sunitinib and temsirolimus in sequence.Translational Research 48 months Primary tumour tissue specimens and baseline blood samples, will be obtained from all subjects prior to first dose for genetic analysis and other evaluation. In addition, optional for responding patients will be a fresh tumour biopsy at time of progression and also optional for patients entered in the second stage of accrual for any disease cohort will be fresh tumour biopsy at baseline.
Safety Monitoring Daily up to an expected average of 4 weeks after treatment Adverse events will be monitored on an ongoing basis by the central office and their frequencies reported annually at investigators' meetings.
Trial Locations
- Locations (17)
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
BCCA - Cancer Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Izaak Walton Killam (IWK) Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
CHU Sainte-Justine
🇨🇦Montreal, Quebec, Canada
McGill University - Dept. Oncology
🇨🇦Montreal, Quebec, Canada