Everolimus Versus Sunitinib in Non-Clear Cell Renal Cell Carcinoma (NCT01185366) | Clinical Trial Compass
TerminatedPhase 2
Everolimus Versus Sunitinib in Non-Clear Cell Renal Cell Carcinoma
United States73 participantsStarted 2010-08
Plain-language summary
The goal of this clinical research study is to compare the effectiveness of Afinitor (everolimus) and Sutent (sunitinib) for the treatment of advanced renal cell carcinoma (kidney cancer). The safety of each treatment will also be studied.
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
. Patients must have advanced non-clear cell RCC, which may include but is not limited to the following subtypes: papillary I or II, chromophobe, collecting duct carcinoma (CDC), translocation or unclassified. Patients with conventional-type renal cell carcinoma who have \>/= 20% sarcomatoid component in their primary tumor are eligible. Patients who have sarcomatoid features in FNA or core biopsy of any metastatic site are eligible, if they have an underlying renal cell carcinoma primary tumor.
. Patients must have at least one measurable site of disease that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation
. ECOG performance status 0-1
. Age \>/= 18 years
. Patients must have adequate organ and marrow function within 14 days prior to study entry as defined below: a) Hemoglobin \>/= 9 g/dl (tx allowed); b) absolute neutrophil count \>/=1,500/microL; c) platelets \>/= 100,000/microL; d) total bilirubin \</= 1.5 mg/dl; e) AST(SGOT) or ALT (SGPT) \</=2.5 X institutional uln, except in known hepatic metastasis, wherein may be \</= 5 x ULN; f) Serum Creatinine \</= 1.5 x ULN (as long as patient does not require dialysis)
. INR and PTT \</= 1.5 x ULN within 14 days prior to study entry. Therapeutic anticoagulation with warfarin is allowed if target INR \</= 3 on a stable dose of warfarin or on a stable dose of LMW heparin for \> 2 weeks (14 days) at time of randomization.
. Fasting serum cholesterol \</= 300 mg/dL OR \</= 7.75 mmol/L AND fasting triglycerides \</= 2.5 x ULN within 14 days prior to study entry.
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.
What they're measuring
1
Progression Free Survival (PFS) for First Line Medication
Timeframe: 7 months
2
Progression Free Survival (PFS) for Crossover Medication
. Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a negative serum or urine pregnancy test within 14 days before study entry. Pregnancy test must be repeated if performed \> 14 days before starting study drug.
Exclusion criteria
. No other malignancies within the past 2 years except for adequately treated carcinoma of the cervix or basal (without recurrence post-surgery or post-radiotherapy) or squamous cell carcinomas of the skin.
. No prior systemic therapy for RCC including prior adjuvant therapy or investigational drug is allowed.
. Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks (28 days) from enrollment into this study (including chemotherapy and targeted therapy) are excluded. However, patients are permitted to receive bisphosphonates. Also, patients who completed palliative radiation therapy prior to enrollment in this trial are eligible.
. Patients, who have had a major surgery or significant traumatic injury (injury requiring \> 4 weeks (28 days) to heal) within 4 weeks (28 days) of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study.
. Concomitant treatment with rifampin, St. John's wort, or the cytochrome p450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or Phenobarbital) or CYP3A4 inhibitors is not recommended on this study.
. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: a) Symptomatic congestive heart failure of New York heart Association Class III or IV; b) unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease; c) severely impaired lung function as defined as 02 saturation that is 88% or less at rest on room air
. (#6 cont'd) d) uncontrolled diabetes as defined by fasting serum glucose \>1.5 x ULN; e) active (acute or chronic) or uncontrolled severe infections requiring antibiotic intervention; f) liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
. Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of sunitinib or everolimus or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.