Clinical Trial VICCURO1032
A Randomized Phase II Study of Afinitor (RAD001) vs. Sutent (Sunitinib) in Patients with Metastatic Non-Clear Cell Renal Cell Carcinoma (ASPEN)
- Protocol No. VICCURO1032
- Open Date: 12/10/2010
- Staging: Phase II
- Age Group: Adults
- Scope: International
- Objective: The comparison of progression-free survival (PFS) between the treatment arms following therapy initiation.
- Disease Sites: Urologic; Kidney (Renal Cell)
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Everolimus (RAD001); SU011248 (Sunitinib); Sunitinib
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01108445
- Secondary Protocol No: ASPEN & CRAD001L2402T
You are being asked to take part in this research study because you have a specific type of kidney cancer. Research studies include only people who choose to take part. Please read this consent form carefully and take your time making your decision. As your study doctor or study staff discusses this consent form with you, please ask him/her to explain any words or information that you do not clearly understand. We encourage you to talk with your family and friends before you decide to take part in this research study. The nature of the study, risks, inconveniences, discomforts, and other important information about the study are listed below. Please tell the study doctor or study staff if you are taking part in any other research study. One study drug, everolimus (Afinitor) is made by Novartis, a pharmaceutical corporation, and is available as an oral drug product. Everolimus has been approved since May of 2009 by the US Food and Drug Administration (FDA) for the treatment of patients with kidney cancer. The other drug, sunitinib (Sutent), is made by Pfizer, a different pharmaceutical corporation, and is available as an oral drug product. Sunitinib has been approved since January of 2006 by the US FDA for the treatment of patients with kidney cancer and stomach cancers. Several thousand patients have been treated worldwide with each of these agents for kidney cancer. Why Is This Study Being Done- You have an uncommon type of kidney cancer called non-clear cell kidney cancer. Right now, there is no standard treatment for this specific type of kidney cancer. However, there is some early information to support treatment with either everolimus or sunitinib. However, it is unknown which of these drugs is more helpful to patients with non-clear cell kidney cancer. The purpose of this study is to learn what the effects are of everolimus or sunitinib on you and your cancer. These effects may include the ability of these study drugs to shrink your cancer, to keep your cancer from growing, to keep your cancer from spreading, and to keep your cancer from making your health worse. We will be also measuring how well you feel while on these study drugs. There are two different study drugs used in this study, and you will be randomized (like flipping a coin) to receive one of them. Your doctor has no control over which treatment arm you will be assigned to. You have a 50% chance of being assigned to either the everolimus or the sunitinib arm. You will remain on the study until the study drug is no longer working or until the study drug causes severe side effects on your body. You may also ask to be removed from this study at any time. How Many People Will Take Part In The Study- About 108 people will take part in this study at about 20 different hospitals and medical centers within the United States and Canada. About 6 people will take part at Vanderbilt.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
1. Histologically confirmed advanced Renal Cell Carcinoma (RCC), with non-clear cell pathology.
2. RCC tumor tissue available for correlative sciences, from either primary or metastatic site or both.
3. At the time of screening, at least 4 weeks since prior palliative radiation therapy and/or major surgery, and resolution of all toxic effects of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 4.0) Grade 1.
4. Subject must have radiographic evidence of metastatic disease with at least 1 measurable per RECIST 1.1 criteria (Attachment 1)].
5. Age > 18 years.
6. Adequate laboratory values
7. Karnofsky Performance Status ≥ 60 (Attachment 2).
8. Life expectancy of at least 3 months.
9. Written, signed, dated, and witnessed Institutional Review Board (IRB) or Institutional Ethics Committee (IEC) approved informed consent form (ICF) before any screening procedures are performed.
1. Subjects with a history of or active central nervous system (CNS) metastases.
2. Prior systemic therapy for RCC, including mTOR and anti-angiogenic therapy, chemotherapy, biologic or experimental therapy.
3. Subjects with collecting duct, medullary, small cell, oncocytoma, or lymphoma-type pathology.
4. Subjects receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers.
5. Major surgery, open biopsy, traumatic injury, or radiotherapy within 4 weeks of the screening visit.
6. Subjects who have not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy.
7. Presence of a non-healing wound or ulcer.
8. Grade 3 hemorrhage within the past month.
9. Hypertension with systolic blood pressure of >180 mm Hg and/or diastolic pressure >100 mm Hg.
10. Subjects with American Heart Association (AHA) Class 2-4 heart disease or any history of congestive heart failure with an ejection fraction <50%, or history of unstable angina, myocardial infarction, coronary artery bypass graft, cerebrovascular accident, transient ischemic attack, or pulmonary embolism within 12 months of entry.
11. Diabetes mellitus with glycosylated hemoglobin A1c (HbgA1c) > 10% despite therapy.
12. A history of interstitial pneumonitis.
13. Subjects with active autoimmune disorder(s) being treated with immunosuppressive agents within 4 weeks prior to the screening visit.
14. Subjects receiving immunosuppressive agents and those with chronic viral/bacterial/fungal illnesses such as human immunodeficiency virus (HIV).
15. Patients who have receive immunization with attenuated live vaccines within one week of study entry or during study period.
16. Patients with active infection(s), active antimicrobial therapy or serious intercurrent illness.
17. History of other prior malignancy in past 5 years.
18. Pregnant or nursing women.
19. Major medical/psychiatric illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study, including inability to absorb oral medications and history of noncompliance to medical regimens.
20. Known hypersensitivity to any of the components in everolimus or sunitinib product
21. QTc interval on baseline EKG of >470 milliseconds.
22. Subjects taking agents that significantly prolong the QTc interval are not eligible.
23. Proteinuria with a spot urine protein/creatinine ratio >2 or 24 hour urine protein >2 grams per 24 hours.
24. Severely impaired lung function as defined as spirometry and Carbon Monoxide Diffusing Capacity (DLCO) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air.
25. Advanced liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).