Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Medical University of South Carolina |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00103376 |
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 | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: bicalutamide Drug: bortezomib Drug: flutamide Drug: goserelin Drug: leuprolide acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer |
Estimated Enrollment: | 42 |
Study Start Date: | October 2004 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Relapsed disease after definitive local therapy, as documented only by a rise in prostate-specific antigen (PSA)
Rising PSA (≥ 1.0 ng/mL after nadir < 1.0 ng/mL)
No metastatic disease (M0)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Recruiting |
Loma Linda, California, United States, 92354 | |
Contact: Clinical Trials Office - Loma Linda University Cancer Institut 909-558-3375 | |
United States, South Carolina | |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Recruiting |
Spartanburg, South Carolina, United States, 29303 | |
Contact: Clinical Trials Office - Gibbs Regional Cancer Center 800-486-5941 | |
Hollings Cancer Center at Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Andrew S. Kraft, MD 843-792-9321 | |
South Carolina Oncology Associates, PA | Recruiting |
Columbia, South Carolina, United States, 29210 | |
Contact: William M. Butler, MD 803-461-3708 wbutler@sconcology.net |
Principal Investigator: | Andrew S. Kraft, MD | Medical University of South Carolina |
Responsible Party: | Hollings Cancer Center at Medical University of South Carolina ( Andrew S. Kraft ) |
Study ID Numbers: | CDR0000406013, MUSC-031218, MUSC-HR-11357 |
Study First Received: | February 7, 2005 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00103376 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the prostate recurrent prostate cancer |
Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Hormone Antagonists Bortezomib Hormones, Hormone Substitutes, and Hormone Antagonists Goserelin Urogenital Neoplasms Genital Diseases, Male Flutamide |
Hormones Recurrence Protease Inhibitors Androgen Antagonists Leuprolide Bicalutamide Adenocarcinoma Prostatic Neoplasms Androgens |
Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Bortezomib Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Urogenital Neoplasms Reproductive Control Agents |
Genital Diseases, Male Pharmacologic Actions Protease Inhibitors Androgen Antagonists Neoplasms Neoplasms by Site Leuprolide Fertility Agents, Female Therapeutic Uses Fertility Agents Bicalutamide Prostatic Neoplasms |