MDACC Study Summary 2006-0684

Study Summary
No. 2006-0684:.......Prostate......Paul Corn......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	2006-0684

Study Title:	Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer.

Physician

New Patient Referral



Name:	Paul Corn	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Genitourinary Medical Oncology	Referring 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

General Information



Disease Group:	Prostate	Supported By:	Pfizer

Phase of Study:	Phase I	Return Visit:	At 2 and 4 weeks following initiation of sunitinib, daily for radiation therapy then every 4 weeks for 3 months, then every 3 months for 2 years, then every 6 months till the 5 year mark, then yearly until the 10 year mark.

Treatment Agents:	Casodex Goserelin Acetate Leuprolide Acetate Radiation Sunitinib Malate	Home Care:	Oral sunitinib and casodex may be taken at home.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn the safety of adding 3 different dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation in patients with prostate cancer.

Study Objectives / Outcomes

Primary:

1. To define the tolerability of three different dose-levels of the angiogenesis inhibitior, sunitinib malate, in combination with hormone ablation and external beam radiation for high-risk and locally advanced prostate cancer.

Secondary:

1. Evaluate putative biomarkers of outcome at baseline, after sunitinib lead-in and at 12 and 24 months after completion of radiation therapy.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	02/15/2008

Study Type:	Phase I

Recruitment Status:	Closed

Projected Accrual:	22

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) Adenocarcinoma of the prostate with the following high-risk features are eligible: clinical T2c, clinical or pathological T3 or T4 disease OR Gleason 8-10 disease OR PSA > 20ng/ml.

2) Patients must have no evidence of metastatic disease by clinical and radiological staging including Chest X-ray, Bone scan and CT Scan of the Abdomen and Pelvis.

3) ECOG Performance Status 0-1

4) Calculated Creatinine clearance > 35cc/min, Absolute neutrophil count > 1,500/mm^3, Platelets >/= 100,000/mm^3, AST/ALT < 2.5 x UNL, Total bilirubin WNL.

5) No standard contraindications to radiation therapy including prior radiation therapy, inflammatory bowel disease, irritable bowel syndrome, or and collagen vascular disease.

6) Patients must be at least 18 years of age

7) Patients may have had up to 8 weeks of hormonal therapy defined as luteinizing-hormone releasing hormone or other medical castration therapy prior to registration.

Exclusion Criteria:

1) Prior VEGFR/PDGFR inhibitor or other investigational therapy.

2) Inability to take oral medication

3) Chronically uncontrolled hypertension, defined conventionally as consisten/repeated systolic pressures above 140 mmHg or diastolic pressures above 90 mmHg despite anti-hypertensive therapy. This may be established with home BP readings. There is no criterion related to a specific BP result required for eligibility, nor are acute BP elevations that are related to iatrogenic causes, acute pain, or other transient reversible causes considered an exclusion criteria. The intent is to exclude patients with chronically uncontrolled hypertension that might be further exacerbated by Sunitinib.

4) Left Ventricular Ejection Fraction </= 40%, symptomatic congestive heart failure or symptomatic ischemic heart disease, deep venous thrombosis or pulmonary embolism in the last 12 months.

5) Known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or liver cirrhosis

Links

Registration Number: NCT00631527
Study Information on Clinical Trials Registry (clinicaltrials.gov)