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Study Summary
No. 2006-0437:.......Kidney......Nizar M. Tannir......Genitourinary Medical Oncology
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Study Summary Title
Study Summary
Number:		2006-0437
Study Title:Phase II Trial of Sunitinib Malate (Sutent)® Therapy in Patients with Advanced Non-clear Cell Renal Cell Carcinoma.
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Physician New Patient Referral
Name:Nizar M. TannirPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Genitourinary Medical OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2830
Contact us about clinical trials
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General Information
Disease Group:KidneySupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Participants are required to return to MDACC at Day 29 of Cycle 1 and Day 1 of
every cycle, beginning with Cycle 3.
Treatment
Agents:		SU011248Home Care:Participants are responsible for taking a single daily dose of 50 mg of
sunitinib malate continuously for 4 weeks followed by a two-week off period for
a 6-week cycle. Blood testing will be done at a local physician on Day 15 of
each cycle.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this clinical research study is to learn the effectiveness of
Sutent® (sunitinib malate, SU011248) in the treatment of patients with
non-clear cell renal cell cancer. The safety of sunitinib malate will also be
studied.
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Study Objectives / Outcomes
Primary
· To determine the clinical activity of SUTENT® (sunitinib malate) in non-clear cell renal cell cancer (RCC). Clinical activity will take into account response rate and progression free survival (PFS).

Secondary
· To determine the toxicity of sunitinib malate in non-clear cell RCC.
· To estimate the survival rate of patients with non-clear cell RCC treated with sunitinib malate
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Study Status Information
Study Activation / Registration Date:03/28/2007
IRB Review and Approval Date:07/21/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients must have histologically or cytologically confirmed advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), 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.

2) Patients must have measurable disease.

3) ECOG performance status 0-1.

4) Patients must have adequate organ and marrow function within 14 days prior to study entry as defined: Hemoglobin >/= 9 g/dl, absolute neutrophil count >/= 1,500/microL, platelets >/= 100,000/microL, total bilirubin </= 1.5 mg/dl, AST(SGOT) and/or ALT (SGPT) </= 2.5 X institutional uln, except in known hepatic metastasis, wherein may be </= 5 x uln, serum creatinine </= 4 X uln (as long as patient does not require dialysis).

5) Patients must have recovered from any effects of surgery.

6) Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a normal plasma beta human chorionic gonadotropin (betaHCG) within 24 hours prior to enrolling in the study.

7) Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study (barrier method, hormonal methods, etc.).

8) Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. 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.

9) Patients with brain metastases may participate in this trial.

10) Patients who have had up to two prior systemic therapies are eligible to participate in this trial but they should not have had prior Multi-Tyrosine Kinase Inhibitors such as sorafenib or sunitinib malate.
Exclusion Criteria:1) No prior malignancy is allowed, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 2 years.

2) Pregnant or lactating women are excluded.

3) Patients must not be scheduled to receive any experimental drug for MRCC while on study. Patients are permitted to be on concomitant bisphosphonates. Patients are permitted to receive hematopoietic growth factors according to ASCO guidelines.

4) Patients must not have had prior radiotherapy to areas of measurable disease, unless they have clearly progressive disease in this site, or there is measurable disease outside the area of prior radiation. Radiotherapy, if needed for palliation, must have been completed at least 2 weeks prior to enrollment on this study.

5) Patients may not have any significant medical disease (other than the malignancy) that, in the investigator's opinion, would increase the risk for participation. Examples of exclusion: unstable angina pectoris, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic cardiac arrhythmias requiring medication (subjects with controlled chronic atrial fibrillation are eligible), myocardial infarction within 6 months, uncontrolled HTN (blood pressure >150/90 on therapy), QTc interval > 500msec or other significant ECG abnormalities or uncontrolled DM.

6) 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 malate or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.

7) Concomitant treatment with drugs with dysrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, and indapamide) is not recommended.

8) Patients unwilling to participate or unable to comply with the protocol for the duration of the study.
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Links
Registration Number: NCT00465179
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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