Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Sunitinib Malate (Sutent) Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma|
- Number of Participants With Response to Treatment [ Time Frame: Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years ] [ Designated as safety issue: No ]Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Insufficient shrinkage to qualify for partial response, or insufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Median Progression-Free Survival (PFS) [ Time Frame: Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years ] [ Designated as safety issue: No ]Median Progression-Free Survival was calculated as the time from the date of the first treatment to the date of disease progression or date of death, or the last date of the outcome evaluation, whichever came first.
- Median Overall Survival [ Time Frame: Baseline till participant death or end of follow-up period, assessed every 6 weeks for the first two cycles, then every 12 weeks, up to 5 years. ] [ Designated as safety issue: No ]Overall survival was estimated using the Kaplan-Meier method.
|Study Start Date:||March 2007|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Sunitinib Malate
Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off.
Drug: Sunitinib Malate
50 mg by mouth daily for 4 weeks, then 2 weeks off.
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.
If you are found to be eligible to take part in this study, you will take sunitinib malate once a day (either with or without food) for 4 weeks in a row followed by 2 weeks of rest with no study drug. These 6 weeks are considered 1 cycle of study treatment.
Around Day 15 of each cycle, your vital signs will be measured and recorded, and you will have blood drawn (about 2 teaspoons) for routine testing. These evaluations can be done at your local doctor's office.
You will be required to return to clinic for a follow-up visit around Day 29 of Cycle 1.
At this visit, your medical history will be recorded, and your ability to perform daily activities will be evaluated. You will have a physical exam, including measurement of your vital signs. You will be asked about any side effects you may have experienced since your last visit. You will be asked about any medicines you may be currently taking. You will have blood drawn (about 4 teaspoons) for routine testing.
Beginning Day 1 of Cycle 3, you will return to clinic every 12 weeks (Day 1 of each cycle). You will have the same evaluations as you did at the Day 29 visit.
On Day 1 of every other cycle, you will have an ECG and a doppler echocardiogram or multigated acquisition (MUGA) scan to evaluate your heart health.
You will have follow-up imaging scans (CT and/or MRI) to track your response to treatment on Day 1 of the first 2 cycles and every 12 weeks thereafter for as long as you are receiving treatment on this study.
You will continue to receive treatment on this study, unless your disease gets worse, you develop an illness that prevents you from continuing treatment, or you experience any intolerable side effects of the study drug. You will be removed from this study if any of these circumstances occur.
This is an investigational study. Sunitinib malate has been authorized by the FDA for treatment of clear cell renal carcinoma. Its use in non-clear cell renal carcinoma is experimental. Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465179
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nizar M. Tannir, MD||M.D. Anderson Cancer Center|