Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02060370|
Recruitment Status : Completed
First Posted : February 12, 2014
Results First Posted : February 27, 2020
Last Update Posted : February 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Genitourinary Cancer Kidney Cancer||Drug: Sunitinib Behavioral: Questionnaire||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Alternative Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma (mRCC)|
|Actual Study Start Date :||August 2014|
|Actual Primary Completion Date :||January 2, 2019|
|Actual Study Completion Date :||January 2, 2019|
Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.
Other Name: Survey
- Rate of Toxicity [ Time Frame: Participants were monitored for toxicities for 30 days after treatment was discontinued; total treatment duration approximately 34 months ]Determine the number of participants who experience a specific, treatment-related adverse events at a grade three, four or five: fatigue, hand-foot syndrome, and/or diarrhea. Adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4
- Progression-Free Survival (PFS) [ Time Frame: 17 months ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event [ Time Frame: Participants were monitored for toxicities for 30 days after treatment was discontinued or until death, whichever occurred first. ]Adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4
- Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities [ Time Frame: 2 years ]Reported as the number and percentage of participants who underwent one or more dose reductions, as well as, the number and percentage of participants whose treatment ended.
- Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G) [ Time Frame: 36 weeks from the start of treatment ]Participants completed FACT-G suveys evaluating quality of life at weeks 0, 12, 24, and 36. The score range is from 0 to 180 with higher scores reflecting a better quality of life. The results were reported for each time point for all participants and then broken into two groups: participants with a grade 3 toxicity and participants without a grade 3 toxicity. The total number of surveys changes as the weeks progress.
- Changes in Circulating DNA Levels With Antiangiogenic Treatment [ Time Frame: Not applicable due data not generated due to timing and budgetary issues ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060370
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|United States, North Carolina|
|Lineberger Cancer Center|
|Chapel Hill, North Carolina, United States, 27514|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eric Jonasch, MD||M.D. Anderson Cancer Center|