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Angiogenesis inhibitor
Drug Combinations for Kidney Cancer
Phase 2
Waitlist Available
Led By Amado Zurita, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >/= 18 years
Confirmed metastatic RCC with a clear cell component
Must not have
Known hypersensitivity to any component of bevacizumab, pazopanib or everolimus
Patients must not be scheduled to receive another experimental drug while on this study. Patients are permitted to receive concomitant bisphosphonates
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Summary
This trial is testing six different combinations of two drugs to see which is most effective in treating metastatic kidney cancer.
Who is the study for?
Adults with metastatic renal cell carcinoma (RCC) that includes a clear cell component, who have had surgery or certain other treatments for their primary tumor. They must be able to swallow pills, not have received targeted therapy or chemotherapy for mRCC (though prior immunotherapy is okay), and agree to use birth control. People with active infections, another cancer treatment ongoing, significant heart issues, uncontrolled hypertension or diabetes, severe liver disease, brain metastases (except controlled solitary ones), coagulation disorders on certain anticoagulants are excluded.
What is being tested?
The START trial is testing six different combinations of the drugs everolimus, bevacizumab, and pazopanib in sequences to see which works best against metastatic kidney cancer. Participants will start with one drug and may switch to another as part of the sequence while researchers monitor safety and effectiveness.
What are the potential side effects?
Possible side effects include high blood pressure; bleeding; protein in urine; immune system suppression leading to increased infection risk; hypersensitivity reactions; impaired wound healing; elevated cholesterol or triglycerides levels requiring medication management.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My kidney cancer has spread and shows clear cell features.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not allergic to bevacizumab, pazopanib, or everolimus.
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I am not planning to take any experimental drugs but can take bisphosphonates while in this study.
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I do not have high levels of protein in my urine.
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I have a serious wound or fracture that is not healing.
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I am not pregnant or breastfeeding.
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I haven't had major surgery or a serious injury in the last 28 days and don't expect to need major surgery during the study.
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I am not taking rifampin, St. John's wort, or certain seizure medications.
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My lung function is severely impaired, with low oxygen levels or less than half the normal lung capacity.
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I do not have serious heart problems.
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My blood pressure is controlled and I have never had a hypertensive crisis.
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I have coughed up a significant amount of blood recently.
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I have a serious blood vessel condition like an aortic aneurysm.
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I have symptoms of poor blood flow in my limbs.
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I am not HIV-positive or on anti-retroviral therapy.
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I am not receiving treatment for any cancer other than kidney cancer.
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I do not have any infections that aren't responding to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to Overall Treatment Failure
Trial Design
6Treatment groups
Experimental Treatment
Group I: Group 6Experimental Treatment2 Interventions
Bevacizumab + possible Everolimus
Group II: Group 5Experimental Treatment1 Intervention
Bevacizumab + possible Pazopanib
Group III: Group 4Experimental Treatment2 Interventions
Everolimus + possible Pazopanib
Group IV: Group 3Experimental Treatment2 Interventions
Everolimus + possible Bevacizumab
Group V: Group 2Experimental Treatment2 Interventions
Pazopanib + possible Everolimus
Group VI: Group 1Experimental Treatment2 Interventions
Pazopanib + possible Bevacizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510
Bevacizumab
2013
Completed Phase 4
~5540
Pazopanib
2012
Completed Phase 4
~1370
Find a Location
Who is running the clinical trial?
NovartisIndustry Sponsor
1,624 Previous Clinical Trials
2,723,602 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,521 Total Patients Enrolled
Amado Zurita, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
210 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your diabetes is not well managed, as shown by high fasting blood sugar levels.I am not allergic to bevacizumab, pazopanib, or everolimus.I am not planning to take any experimental drugs but can take bisphosphonates while in this study.I do not have multiple brain tumors or cancer in the lining of my brain, but may have one controlled brain tumor.I can swallow pills.I have a serious wound or fracture that is not healing.I do not have severe liver disease or cirrhosis.I am 18 years old or older.I haven't had targeted or chemotherapy for my kidney cancer, but may have had immunotherapy.I am not pregnant or breastfeeding.I haven't had major surgery or a serious injury in the last 28 days and don't expect to need major surgery during the study.I don't have a history of bleeding disorders but may be on blood thinners.I am not taking rifampin, St. John's wort, or certain seizure medications.I haven't had any major abdominal issues like fistula, perforation, or abscess in the last 6 months.My lung function is severely impaired, with low oxygen levels or less than half the normal lung capacity.You have a disease that can be measured or observed.Your blood counts and organ function need to be within certain levels to be eligible for the study. This includes having a certain level of white blood cells and platelets, and your liver and kidney functions need to be within specific ranges.I am a woman who can have children and have a recent negative pregnancy test.I have not had a stroke or mini-stroke in the last 6 months.I do not have serious heart problems.I have symptoms of poor blood flow in my limbs.I am not on long-term steroids or immune-suppressing drugs, except for low-dose or topical use.I do not have high levels of protein in my urine.My blood pressure is controlled and I have never had a hypertensive crisis.I have coughed up a significant amount of blood recently.I have a serious blood vessel condition like an aortic aneurysm.My kidney cancer has spread and shows clear cell features.I had surgery or a procedure to remove or treat my kidney tumor.I am fully active or can carry out light work.I am not HIV-positive or on anti-retroviral therapy.I am not receiving treatment for any cancer other than kidney cancer.I do not have any infections that aren't responding to treatment.I haven't had any live vaccines recently and will avoid close contact with anyone who has.I am eligible regardless of my gender, race, or ethnicity.
Research Study Groups:
This trial has the following groups:- Group 1: Group 6
- Group 2: Group 1
- Group 3: Group 5
- Group 4: Group 2
- Group 5: Group 4
- Group 6: Group 3
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.
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