Trail of Taxotere Plus Sunitinib on Newly Diagnosed, Hormone Refractory, Metastatic Prostate Cancer
Recruitment status was Recruiting
The purpose of this research study is to evaluate the response of Taxotere (docetaxel/prednisone) plus Sunitinib in subjects with newly diagnosed prostate cancer stage D1 or D2 which means cancer that has spread to lymph nodes near or far from the prostate, or to other parts of the body, such as the bladder, rectum, bones, liver, or lungs, with either measurable or non-measurable disease. This is an advanced stage of prostate cancer which considered incurable with standard therapy.
Taxotere is a chemotherapy drug that is approved by the FDA for treatment of certain types of breast and lung cancer. It has also been studied extensively and approved for subjects with prostate cancer that has spread to other parts of the body. In these studies, Taxotere® has been shown to shrink tumors in some subjects with prostate cancer. Taxotere® is being tested in this study to see if it can help reduce the chance of prostate cancer returning after surgery. It has not been approved for use in the kind of cancer that subjects in this study have, so the use of Taxotere® in this study is considered experimental.
Sutent (sunitinib) is designed to block tumor cell growth in several ways. Sutent targets several enzymes on blood vessel cells and tumor cells. Several of these targets are thought to be involved in angiogenesis (making of blood vessels). Sutent was approved by the FDA for the treatment of advanced renal cell cancer. Sutent has also been approved by the FDA for the treatment of certain types of intestinal cancerous growths (gastrointestinal stromal tumors) after these tumors have grown in size or the subject was not able to take a drug called imatinib mesylate (Gleevec®).
Subjects will first receive Sunitinib orally once daily at a 37.5 mg starting dose for two weeks to assure tolerability. Dose reductions of Sunitinib will be required in the case of clinically relevant grade 3 or 4 toxic effects (to 25 mg/day then 12.5 mg/day given criteria for withdrawal from study drug are not met). Then, subjects will receive docetaxel (75 mg/m2) every 21 days plus prednisone 5mg twice a day and a tolerant dose of Sunitinib derived from above for a total of 6 cycles. After docetaxel/prednisone/ Sunitinib, a tolerant dose of Sunitinib in 6-week cycles with 4 weeks on and 2 weeks off treatment will be continued for an additional 6 months.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Phase II Study to Determine the Effects of Taxotere Plus Sunitinib on Newly Diagnosed, Hormone Refractory, Symptomatic and Asymptomatic, Metastatic Prostate Cancer Who Are Chemotherapy-naïve.|
- PSA response defined by >30% decrease in PSA from baseline for at least 3 months during study therapy. [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
- Objective response rate (ORR) [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
- Duration of response (DR) [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
- Time to progression (TTP) by PSA response and disease response [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
- Two and three year survival [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
- Qualitative and quantitative toxicity [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Experimental: Sunitinib Plus Docetaxe and Prednisone
Sunitinib orally once daily at a 37.5-mg starting dose for two weeks to assure tolerability followed by docetaxel every 21 days plus prednisone twice a day and a dose of Sunitinib for the first 4 weeks for a total of 6 cycles. After deocetaxel/prednisone/ Sunitinib, subject will continue to take tolerated dose of Sunitinib in 6-week cycles with 4 weeks on and 2 weeks off treatment will be continued for an additional 6 months.
Drug: Sunitinib Plus Docetaxel and Prednisone:
Docetaxel will be administered intravenously at the starting dose of 75 mg/m2 every 3 weeks. Prednison 5 mg orally twice daily. Sunitinib will be administered orally for 2 weeks every 3 weeks (Schedule 2/1), beginning on Day 2 at a starting dose of 37.5 mg daily.
Other Name: SUTENT Plus TAXOTERE and DELTASONE
|Contact: Chao Family Comprehensive Cancer Center University of California, Irvine||1-877-UC-STUDYemail@example.com|
|United States, California|
|Chao Comprehensive Cancer Center||Recruiting|
|Orange, California, United States, 92868|
|Principal Investigator:||John P FRUEHAUF, MD||Chao Family Comprehensive Cancer Center|