Clinical Trial: Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Trial of Sunitinib Malate (Sutent) Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma

Brief Summary: The goal of this clinical research study is to learn the effectiveness of Sutent® (sunitinib malate, SU011248) in the treatment of patients with non-clear cell renal cell cancer. The safety of sunitinib malate will also be studied.

Detailed Summary:

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
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome:

• 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 ]
  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 ]
  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.

Original Primary Outcome:

Current Secondary Outcome: 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. ]

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: April 20, 2007
Date Started: March 2007
Date Completion:
Last Updated: May 4, 2016
Last Verified: May 2016