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Sunitinib Before and After Surgery for Kidney Cancer
Phase 2
Waitlist Available
Led By Keith T. Flaherty, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of renal cell carcinoma
AJCC stage IV disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying sunitinib given before and after surgery to see how well it works in treating patients with stage IV kidney cancer.
Who is the study for?
This trial is for adults with stage IV kidney cancer who are fit for surgery, have not had prior systemic therapy or brain metastases, and do not need preoperative embolization. They should be relatively healthy (ECOG status 0-1), have acceptable organ function tests, control any hypertension or thyroid abnormalities with medication, and agree to use contraception if fertile.Check my eligibility
What is being tested?
The study is testing the effectiveness of Sunitinib when given before and after surgical removal of the kidney tumor. The goal is to see if this treatment can shrink tumors before surgery and eliminate remaining cancer cells afterwards in patients with advanced kidney cancer.See study design
What are the potential side effects?
Sunitinib may cause side effects such as fatigue, high blood pressure, bleeding issues, digestive problems like nausea or diarrhea, skin reactions including rash or discoloration, changes in hair color, mouth sores, altered taste sensation and hand-foot syndrome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with kidney cancer.
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My cancer is at stage IV.
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I do not have any other types of cancer.
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I do not have serious heart rhythm problems.
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My thyroid function is normal with medication.
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My high blood pressure is controlled with medication.
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My kidney function, measured by creatinine levels, is within the normal range.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Tumor regression as assessed by RECIST criteria
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Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,044 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,644 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,885 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with kidney cancer.My cancer is at stage IV.You are using other experimental drugs at the same time.Your partial thromboplastin time (PTT) is within the normal range.I do not have any other types of cancer.I do not have serious heart rhythm problems.I have received systemic therapy before.I am not taking certain seizure medications, rifampin, or St. John's wort.It's been over 2 weeks since my last radiotherapy and I've recovered.I have had radiation for cancer that has spread and caused symptoms.I have or had brain metastases.I haven't had any cancer except for skin cancer in the last 5 years.I do not have any serious illnesses that would interfere with the study.Your liver enzyme levels are not too high, unless you have cancer that has spread to your liver.My thyroid function is normal with medication.I have a history of cancer.You have enough infection-fighting white blood cells in your body.My scans show I need kidney surgery that doesn't require pre-surgery vessel blocking.My high blood pressure is controlled with medication.Your blood clotting test result (INR) must be within a specific range.Your bilirubin levels in the blood should be within a certain range, and may be slightly higher if you have Gilbert's disease.My kidney function, measured by creatinine levels, is within the normal range.You need to have a test that shows you are not pregnant.Your white blood cell count is at least 3,000 per cubic millimeter.Your platelet count is at least 100,000 per cubic millimeter.I have had a condition where my lymphocytes grow abnormally.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this therapeutic regimen been approved by the U.S. Food & Drug Administration?
"Our Power team scored the safety of this medication a 2, since there is evidence to back up its security profile but no proof yet demonstrating it can effectively treat illnesses."
Answered by AI
Is enrollment still available for this clinical trial?
"As per clinicaltrials.gov, this trial is not presently seeking candidates; it was initially posted back in June 2008 and most recently updated on January 9th 2014. Notwithstanding, 423 other medical studies are actively recruiting participants right now."
Answered by AI
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