Study of SU11248 in Men With Advanced Prostate Cancer (NCT00299741) | Clinical Trial Compass
CompletedPhase 2
Study of SU11248 in Men With Advanced Prostate Cancer
United States36 participantsStarted 2006-03
Plain-language summary
* 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 National Cancer Institute Common Toxicity Criteria Adverse Event (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.
* Eastern Cooperative Oncology Group 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
* Asparate aminotransferase and alanine aminotransferase \< 2.5 x upper limit of normal
* Adequate renal function, with serum creatinine \< 2 x upper limit of normal
* Prostate Specific Antigen (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
* Dise…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response
Timeframe: were followed until disease progression, an average of 12 weeks