Bortezomib With or Without Hormone Therapy in Treating Patients With Relapsed Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00103376|
Recruitment Status : Completed
First Posted : February 8, 2005
Last Update Posted : April 30, 2012
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, leuprolide, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Giving bortezomib with hormone therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bortezomib with or without hormone therapy works in treating patients with relapsed prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: bicalutamide Drug: bortezomib Drug: flutamide Drug: goserelin acetate Drug: leuprolide acetate||Phase 2|
- Determine the prostate-specific antigen (PSA) relapse after an observed rise in testosterone after combination treatment with hormone blockade and bortezomib.
- Determine the safety of this drug in combination with combined androgen blockade therapy in these patients.
- Determine the disease-free interval in patients treated with this regimen.
- Determine time to tsetosterone rise in patients treated wtih this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive androgen blockade therapy comprising a 3-month subcutaneous injection of goserelin OR leuprolide OR other FDA-approved method of primary androgen suppression AND oral flutamide or bicalutamide once daily for 3 months. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment with bortezomib repeats every 28 days for 3 courses. Patients achieving a CR discontinue treatment and are observed for PSA or metastatic disease recurrence. Patients with a PR or stable disease receive additional combined androgen blockade therapy and 3 additional courses of bortezomib as above. Patients with progressive disease are removed from the study.
Patients are followed every 3 months for up to 5 years.
PROJECTED ACCRUAL: A total of 21-42 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Masking:||None (Open Label)|
|Official Title:||VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
- Prostate-specific antigen (PSA) response as measured by complete or partial response, stable or progressive disease 3 months after initial treatment
- Time to PSA relapse as measured by lab tests 3 months after initial treatment
- Safety as assessed by Common Toxicity Criteria, medical history, physical exams, and lab values weekly after combined treatment
- Disease-free interval assessed 3 months after combined treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103376
|United States, California|
|Loma Linda University Cancer Institute at Loma Linda University Medical Center|
|Loma Linda, California, United States, 92354|
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|South Carolina Oncology Associates, PA|
|Columbia, South Carolina, United States, 29210|
|Gibbs Regional Cancer Center at Spartanburg Regional Medical Center|
|Spartanburg, South Carolina, United States, 29303|
|Principal Investigator:||Andrew S. Kraft, MD||Medical University of South Carolina|