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Study Summary
No. 2006-0685:.......Genitourinary; Testis......Lance Pagliaro......Genitourinary Medical Oncology
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Study Summary Title
Study Summary
Number:
2006-0685
Study Title:Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors
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Physician New Patient Referral
Name:Lance PagliaroPatients 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:Genitourinary
Testis
Supported By:Pfizer
Phase of Study:Phase IIReturn
Visit:
Patients must return to MDACC on Day 1 of each cycle for follow-up assessments.
Treatment
Agents:
Sunitinib MalateHome Care:Patients are responsible for taking sunitinib malate by mouth daily.
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 if Sutent® (sunitinib
malate, SU011248) can control the disease in patients with germ cell tumors
that are resistant to earlier treatment.
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Study Objectives / Outcomes
Primary:

To define the 12 week progression free survival rate in refractory germ cell tumors treated with sunitinib malate.

Secondary:

To study a) the objective response rate, b) tumor marker outcomes c) qualitative and quantitative toxicity d) putative biomarkers of response to therapy in refractory germ cell tumors treated with sunitinib malate, e) to estimate the progression free survival rate.
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Study Status Information
Study Activation / Registration Date:05/29/2009
IRB Review and Approval Date:08/30/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Closed
Projected Accrual:42
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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) Progressive metastatic GCTs of gonadal or extragonadal origin in males after failure of front-line therapy and at least one salvage regimen.

2) Must have evaluable or measurable disease by clinical or radiological studies. Alternatively, in the absence of radiologically evaluable or measurable disease, two sequentially rising marker values each one week apart attributed by treating physician to germ cell tumor is permitted; either beta HCG above 50 mIU/ml and/or AFP above 20 ng/ml qualifies as eligible.

3) ECOG Peformance Score 0-2

4) Adequate organ function as follows: Calculated creatinine clearance >/= 35cc/min, Absolute neutrophil count >/= 1500/mm^3, hemoglobin >/= 8 g/dL, serum calcium </= 12 mg/dL, Platelet count >/= 75,000/mm^3, AST/ALT < 2.5 x ULN, Total bilirubin < 2.0mg/dl.

5) Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade </= 2.

6) At least 18 years of age as safety of sunitinib in a pediatric population has not been established.

7) Able to provide informed consent

8) Must be able to ingest oral medication

9) Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.

10) Patients who have not received prior high-dose chemotherapy and stem cell rescue as salvage therapy will have this option discussed with them. Only patients ineligible, unwilling or unable to undertake this option will be eligible for this trial.

Exclusion Criteria:1) NCI CTCAE Version 3.0 grade 3 hemorrhage within the 4 weeks prior to starting the study treatment.

2) Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.

3) Patients with history of Long QT syndrome.

4) Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade >/= 2.

5) Uncontrolled Hypertension (> 140/90 mm Hg despite optimal medical therapy).

6) Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.

7) Symptomatic bowel obstruction.

8) Prior VEGFR/PDGFR inhibitor therapy.

9) Known human immunodeficiency virus infection, chronic active hepatitis or liver cirrhosis.

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Links
Registration Number: NCT00912912
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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