Study of SU11248 in Men With Advanced Prostate Cancer - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Department of Defense
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00299741

Purpose

There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new cancer treatments.
SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or more specifically receptor tyrosine kinases, in tumor cells. These proteins are active in cellular pathways that are important for development and growth of a variety of different cancers. The targets of SU011248 include the receptors for vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and others. By blocking the VEGF and PDGF pathways, SU011248 can induce death of the blood vessels that nourish the cancer cells and death of the cancer cells themselves.
SU011248 has demonstrated significant anti-tumor activity in renal cell carcinoma, gastrointestinal stromal tumors, and other cancers. Its effect against prostate cancer has not been studied to date.
This study is directed at two populations of men with advanced prostate cancer:
1. Men with advanced prostate cancer who have a rising PSA despite hormone therapy, but have not yet received any chemotherapy.
2. Men with metastatic prostate cancer who have received prior chemotherapy (with a docetaxel-based regimen) and have increasing disease following chemotherapy.
Men in this study will receive SU011248 on a six-week repeating schedule, with four weeks of daily treatment followed by a two-week rest. The goals of the study are:
1. to determine whether SU011248 is an important therapeutic agent in men with advanced prostate cancer, and
2. to identify predictive markers of anti-cancer activity within individual subjects that would allow selective treatment of appropriate subjects in the future.

Condition	Intervention	Phase
Prostate Cancer	Drug: Sunitinib	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Sunitinib Sunitinib malate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of SU011248 in Men With Advanced Prostate Cancer

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

PSA Response Rate [ Time Frame: Until disease progression ]

Secondary Outcome Measures:

Time to Progression [ Time Frame: Until disease progression ]
Objective Response Rate [ Time Frame: Until disease progression ]
Predictive Biomarkers [ Time Frame: Two months ]
Safety and tolerability [ Time Frame: Until disease progression ]

Enrollment:	34
Study Start Date:	March 2006
Study Completion Date:	June 2007

Arms	Assigned Interventions
1: Experimental Sunitinib	Drug: Sunitinib Sunitinib 50 mg daily, 4/2 schedule

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent indicating that the subject has been informed of all pertinent aspects of the trial.
Adenocarcinoma of the prostate
Male subjects, 18 years of age or older
Life expectancy of > 12 weeks
Resolution of all acute toxic effects of prior chemotherapy, radiotherapy or surgical procedure to NCI CTCAE grade <1
Surgical or ongoing chemical castration
Androgen-independent disease, defined as progressive disease despite surgical or ongoing chemical castration. See section 8.2.3 for definition of progressive disease.
ECOG performance status of 0, 1 or 2
Adequate bone marrow reserve:
- Neutrophil count > 1,500/ul
- Platelet count > 75,000/ul
Adequate hepatic function:
- Serum bilirubin < 1.5 x upper limit of normal
- AST, ALT < 2.5 x upper limit of normal
Adequate renal function, with serum creatinine < 2 x upper limit of normal
PSA > 5.0 ng/mL, based on PSA Working Group Criteria
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures

For Group A only:

· No prior treatment for prostate cancer with cytotoxic chemotherapy

For Group B only:

Radiographic evidence of metastatic prostate cancer
One prior docetaxel-based chemotherapy regimen, minimum of two cycles
Disease progression during treatment with docetaxel, or within 60 days of receiving docetaxel

Exclusion Criteria:

Small cell carcinoma of the prostate
Treatment with extensive external beam radiation therapy or radionuclide therapy within six weeks of study entry. Palliative radiation involving less than 20% of bone marrow reserves must have been completed within four weeks of entry.
Any of the following within the prior 6 months: unstable angina, myocardial infarction, symptomatic congestive heart failure or cerebrovascular accident
Receipt of any investigational anti-cancer agent within 4 weeks of the study
NCI CTCAE grade 3 hemorrhage < 4 weeks of starting study treatment
Uncontrolled hypertension
Prolongation of the QTc interval to > 450 msec
Other serious acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299741

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel-Deaconess Medical Center
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Massachusetts General Hospital

Department of Defense

Investigators

Principal Investigator:

Dror Michaelson, MD PhD

Massachusetts General Hospital

More Information

Study ID Numbers:	W81XWH-05-1-0439
Study First Received:	March 3, 2006
Last Updated:	November 7, 2007
ClinicalTrials.gov Identifier:	NCT00299741
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

Sutent
Sunitinib
Bone

Metastatic
Hormone-refractory
Biomarkers

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Sunitinib

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009