Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy: The START Trial (NCT01217931) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy: The START Trial
United States180 participantsStarted 2011-01-19
Plain-language summary
The goal of this clinical research study is to compare 6 different 2-drug "sequences" of everolimus, bevacizumab, or pazopanib to learn how they may affect metastatic kidney cancer. For the 2-drug sequence, participants will receive 1 of these drugs and may start taking another of these drugs after that. Researchers will also study the safety of these 2-drug sequences.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Confirmed metastatic RCC with a clear cell component.
. Prior radical or partial nephrectomy required. Patients whose primary tumor was treated with cryoablation or radiofrequency ablation would also be eligible.
. Measurable disease
. Age \>/= 18 years. Because no dosing or adverse event data are currently available on the use of these targeted agents in patients \< 18 years of age, children are excluded from this study
. ECOG performance status 0 or 1
. Adequate organ and marrow function within 14 days as defined below: a) Absolute neutrophil count /=\> 1,500/microL; b) Platelets \>/= 100,000/microL; c) Hgb \>/= 9.0 g/dL (transfusion allowed); d) Total bilirubin \< 1.5 mg/dl; e) Albumin \> 2.5 g/dL; f) AST and ALT \</= 2.5 X ULN for subjects without liver metastases; g) AST and ALT \< 5 X ULN for subjects with liver metastases; h) Serum creatinine \</= 2 mg/dL or CrCl \>/= 50 cc/min; i) Fasting serum cholesterol \</= 300 mg/dL or \</= 7.75 mmol/L and fasting triglycerides \</= 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Female patients of childbearing potential must have a negative pregnancy test (serum/plasma or urine) within 7 days prior to beginning treatment on the study due to the possible teratogenic effect
. Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study
Exclusion criteria
. No patient with any concurrent active malignancy, i.e. a patient requiring or receiving systemic therapy for another malignancy at the same time of treatment for RCC
. Patients must not have received any prior targeted therapy (anti-VEGF agents or mTOR inhibitors), including adjuvant therapy, and must not have received any prior chemotherapy for mRCC. However, patients who had received prior immunotherapy, such as cytokines or vaccines, are permitted to enroll.
. Patients must not be scheduled to receive another experimental drug while on this study. Patients are permitted to receive concomitant bisphosphonates.
. Patients must not have multiple brain metastases or leptomeningeal disease. Patients with controlled solitary brain metastasis are eligible.
. Patients must not have had a stroke or transient ischemic attack within 6 months.
. Patients must not have uncontrolled infections.
. Patients must not have clinically significant cardiovascular disease, defined as myocardial infarction (or unstable angina) within 6 months, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia refractory to medical management
. Patients must not have uncontrolled hypertension, defined as \> 140/90 or prior history of hypertensive crisis or hypertensive encephalopathy. Treatment of hypertension with medications is permitted.