MDACC Study Summary 2005-0297 (Archived)

Study Summary
No. 2005-0297:.......Prostate......Amado Zurita......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	2005-0297

Study Title:	A Phase 1/2 Safety and Pharmacokinetic Study of SU011248 In Combination With Docetaxel (Taxotere®) and Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer (HRPC)

Physician

New Patient Referral



Name:	Amado Zurita	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:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Phase I-II: Every 2 weeks for first 4 months of study, then every 3 weeks until progression or intolerable toxicity.

Treatment Agents:	Docetaxel Prednisone SU011248	Home Care:	None

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	None


Description/ Intervention:	The goal of this Phase I portion of this clinical research study is to find the highest dose of the drug sunitinib malate (Sutent®, SU011248) that can be given safely with docetaxel (Taxotere®) and prednisone to patients with prostate cancer whose cancer has spread to other organs.

Study Objectives / Outcomes

Primary Objectives:
Phase I:

To determine the optimal combination dose (OCD) and overall safety and tolerability of SU011248 administered in combination with docetaxel and prednisone in patients with metastatic HRPC.
To evaluate the pharmacokinetics of SU011248 and docetaxel when co-administered with prednisone in patients with metastatic HRPC

Phase II:

To assess the antitumor activity of SU011248 in combination with docetaxel and prednisone in patients with metastatic HRPC.

Secondary Objectives

To assess the duration of tumor control
To assess the objective tumor response rate and survival to patients with metastatic HRPC treated with SU011248 in combination with docetaxel and prednisone
To have preliminary assessment of PSA modulation by SU011248 alone during the lead-in period
To explore correlations of potential biomarkers with treatment-related outcomes
To assess patient reported outcomes including pain, health related quality of life, and advanced prostate cancer related symptoms

Study Status Information



Study Activation / Registration Date:	10/10/2005

IRB Review and Approval Date:	08/03/2005

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	84

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) Histologically or cytologically confirmed adenocarcinoma of the prostate.

2) Progressive HRPC: patients must have undergone primary hormone treatment (e.g. orchiectomy or gonadotropin releasing hormone analog with or without antiandrogens). For patients who received antiandrogen therapy, disease progression must have been documented after antiandrogen therapy discontinuation as defined by:PSA at least 4 weeks or more after flutamide discontinuation OR PSA at least 6 weeks or more after discontinuation of bicalutamide or nilutamide.

3) Progressive disease (PD) based on either nonmeasurable disease and elevated PSA OR measurable disease defined as: Nonmeasurable disease: new metastatic lesions by radionuclide bone scan or plain bone films showing characteristic blastic lesion(s); Elevated PSA: minimum of 2 consecutive rising levels (3 measurements), with an interval of at least 1 week between each determination. Last determination must have minimum value of >/=5ng/ml determined within 2 weeks prior to registration; Measurable disease by transaxial imaging: Pts must show evidence of new or PD by RECIST on CT or MRI scans.

4) Patients who received any other hormonal therapy, including any dose of megestrol acetate, finasteride, ketoconazole, and/or any herbal products known to decrease PSA levels (Saw Palmetto & PC-SPES), or any systemic corticosteroids must have discontinued the agent for at least 4 weeks prior to enrollment. Progressive disease must be documented after discontinuation of the hormonal therapy. Must maintain castrated status: Surgical or ongoing chemical castration with testosterone level <50 ng/dL.

5) Prior biologic, immunotherapy, or palliative radiotherapy to metastatic lesion(s) is permitted provided treatment was completed >4 weeks prior to study entry.

6) ECOG performance status 0 or 1

7) Resolution of all acute toxic effects of prior therapy or surgical procedure to grade </=1.

8) Adequate organ function as defined: AST/SGOT, ALT/SGPT </=1.5 x ULN, or < 2.5 x ULN for patients with liver metastases. Total serum bilirubin </=1.5 x ULN, Absolute neutrophil count >/=1500/microliter, Platelets>/=100,000/microliter, Hemoglobin>/=9.0g/dL, Serum albumin >/=3.0g/dL, Serum Creatinine </=2 x ULN, PT (or INR) </=1.5 ULN, QTc interval </= 470 msec

9) Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.

10) Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of patient-reported outcome measures when specified.

Exclusion Criteria:

1) Small cell or other variant histology

2) Prior thalidomide, anti-VEGF therapy, VEGF receptor inhibitor, PDGF receptor inhibitor or anti-angiogenic treatment of any kind including investigational therapy.

3) Prior chemotherapy treatment and/or prior radioisotope therapy with Strontium-89 or Samarium. Previous treatment with estramustine will be considered chemotherapy.

4) Radiation therapy or surgery within 4 weeks prior to study entry.

5) Prior irradiation to >/= 25% of the bone marrow (whole pelvis=25%)

6) Severe uncontrolled pain (grade 3 or 4) at baseline, impending complication from bone metastasis (fracture and/or compression) and presence of urinary obstruction (urinary retention, hydronephrosis) requiring medical intervention. Properly treated urinary obstruction is allowed.

7) Grade 3 hemorrhage <4 weeks of starting study treatment.

8) Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months.

9) History of or known brain metastases, carcinomatous meningitis, or new evidence of brain or leptomeningeal disease or spinal cord compression on screening CT or MRI scan.

10) Any of the following within the 6 months prior to study drug administration: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, cerebovascular accident, or transient ischemic attack.

11) Ongoing cardiac dysrhythmias of grade >/=2.

12) Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).

13) Ongoing treatment with therapeutic doses of Coumadin or oral anti-vitamin K agents (however, low dose Coumadin up to 2 mg po daily for DVT prophylaxis is allowed). Low molecular weight heparin (LMWH) is allowed.

14) Known human immunodeficiency virus (HIV) infection.

15) Current treatment on another therapeutic clinical trial.

16) Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator would make the patient inappropriate for entry into the trial.

Links

Registration Number: NCT00137436
Study Information on Clinical Trials Registry (clinicaltrials.gov)