Everolimus Versus Sunitinib in Non-Clear Cell Renal Cell Carcinoma
Diagnosis: Kidney Cancer
NCT ID: NCT01185366
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-414
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.
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center
Toni Choueiri, MD,
Dana-Farber Cancer Institute
David McDermott, MD,
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute:
Bon Lam, 617-632-5261,
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
1. 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.
2. Patients must have at least one measurable site of disease according to RECIST
criteria 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
3. ECOG performance status 0-1
4. Age >/= 18 years
5. 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)
6. 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
7. 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.
8. 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.
9. Patients must give written informed consent prior to study entry, in keeping with the
policies of each institution.
10. Patients with a history of major psychiatric illness must be judged (by the treating
physician) able to fully understand the investigational nature of the study and the
risks associated with the therapy.
11. Patients with controlled brain metastases are allowed on protocol if they had
solitary brain metastases that was surgically resected or treated with radiosurgery
or Gamma knife, without recurrence or edema for 3 months (90days).
1. 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.
2. No prior systemic therapy for RCC including prior adjuvant therapy is allowed.
3. 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 at
least two weeks (14 days) prior to enrollment in this trial are eligible.
4. 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.
5. Prior treatment with any investigational drug within the preceding 4 weeks (28 days).
6. 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
7. (#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
8. 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.
9. Concomitant treatment with drugs with dysrhythmic potential (terfenadine, quinidine,
procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone,
and indapamide) is not recommended.
10. Patients receiving chronic, systemic treatment with corticosteroids or another
immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
11. Patients should not receive immunization with attenuated live vaccines within one
week (7 days) of study entry or during study period.
12. Uncontrolled brain or leptomeningeal metastases, including patients who continue to
require glucocorticoids for brain or leptomeningeal metastases.
13. A known history of HIV sero-positivity.
14. Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of everolimus and/or sunitinib (e.g., ulcerative
disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small
15. Patients with an active, bleeding diathesis.
16. Female patients who are pregnant or breast feeding, or adults of reproductive
potential who are not using effective birth control methods. If barrier
contraceptives are being used, these must be continued throughout the trial by both
sexes. Hormonal contraceptives are not acceptable as a sole method of contraception.
(Women of childbearing potential must have a negative urine or serum pregnancy test
within 7 days prior to study entry. Pregnancy test must be repeated if performed > 7
days before administration of everolimus and sunitinib).