Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082680 |
RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and may also make tumor cells more sensitive to chemotherapy. Combining bortezomib with mitoxantrone may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and mitoxantrone in treating patients with advanced or metastatic androgen-independent prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: bortezomib Drug: mitoxantrone hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Weekly Intravenous PS-341 Plus Mitoxantrone in Patients With Advanced Androgen-Independent Prostate Cancer (Al-PCa) |
Estimated Enrollment: | 42 |
Study Start Date: | March 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study.
Patients receive bortezomib IV and mitoxantrone IV on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of patients receive escalating doses of bortezomib and mitoxantrone until the maximum tolerated dose (MTD) is determined using a continuous reassessment method for dose escalation. The MTD is defined as the dose level having a mean posterior dose-limiting toxicity probability closest to 25%.
Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed androgen-independent prostate cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following significant atherosclerotic diseases:
Any of the following significant conduction abnormalities:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Texas | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Arlene Siefker-Radtke, MD | M.D. Anderson Cancer Center |
Investigator: | Christopher Logothetis, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000355822, MDA-ID-02227, MILLENNIUM-MDA-ID-02227 |
Study First Received: | May 14, 2004 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00082680 History of Changes |
Health Authority: | United States: Federal Government |
recurrent prostate cancer stage III prostate cancer stage IV prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Bortezomib Urogenital Neoplasms Peripheral Nervous System Agents Analgesics |
Mitoxantrone Genital Diseases, Male Prostatic Neoplasms Recurrence Protease Inhibitors Androgens |
Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Bortezomib Enzyme Inhibitors Urogenital Neoplasms Genital Diseases, Male Pharmacologic Actions |
Protease Inhibitors Neoplasms Neoplasms by Site Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Mitoxantrone Analgesics Central Nervous System Agents Prostatic Neoplasms |