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Home > "B" Clinical Trials Conditions > Bortezomib and Mitoxantrone in Treating Patients With Advanced or Metastatic Androgen-Independent Prostate Cancer  Bortezomib and Mitoxantrone in Treating Patients With Advanced or Metastatic Androgen-Independent Prostate Cancer
Bortezomib and Mitoxantrone in Treating Patients With Advanced or Metastatic Androgen-Independent Prostate Cancer
For Condition: recurrent prostate cancer,stage 4 prostate cancer,stage 3 prostate cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as mitoxantrone work in different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer by blocking the enzymes necessary for cancer cell growth and may also make cancer cells more sensitive to chemotherapy. Combining bortezomib with mitoxantrone may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with mitoxantrone in treating patients who have advanced or metastaticandrogen-independentprostate cancer.
Details: OBJECTIVES: Primary - Determine the dose-limiting toxicity and maximum tolerated dose (MTD) of bortezomib and mitoxantrone in patients with advanced or metastatic androgen-independent prostate cancer. Secondary - Determine the degree of proteasome inhibition in peripheral blood of patients treated with this regimen. - Correlate the effect of this regimen on prostate-specific antigen (PSA) levels with the degree of proteasomal inhibition in the blood of patients with baseline PSA levels ≥ 5 ng/mL who are treated near the MTD. - Determine the effect of this regimen on selected parameters of clinical benefit (i.e., performance status, tumor-related symptoms, and measurable disease response) in these patients. 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 3 patients receive escalating doses of bortezomib and mitoxantrone until the maximum tolerated dose (MTD) is determined. 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 within 10.5 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed androgen-independent prostate cancer - Advanced or metastatic disease - Requires antineoplastic therapy - Progressive measurable or evaluable disease - Testosterone 50 ng/dL - No uncontrolled brain metastases - No CNS disease PATIENT CHARACTERISTICS: Age - Not specified Performance status - Zubrod 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Hemoglobin > 8.0 g/dL - Platelet count 100,000/mm^3 Hepatic - ALT or AST 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) - Bilirubin 1.5 times ULN Renal - Creatinine 2 mg/dL Cardiovascular - LVEF 50% at rest - None of the following significant atherosclerotic diseases: - Myocardial infarction within the past 6 months - Uncontrolled or unstable angina pectoris - Acute ischemia by ECG - Clinically significant ventricular arrhythmias - Symptomatic congestive heart failure - Any of the following significant conduction abnormalities: - Second- or third-degree atrioventricular block - Bifascicular block (defined as left anterior hemiblock in the presence of right bundle branch block) - Claudication limiting activity - Cerebrovascular events with the past year (including transient ischemic attack) Other - No prior allergic reaction to antidiarrheal medications or antiemetics - No prior severe hypersensitivity reaction to mitoxantrone or other agents formulated with polysorbate 80 - No active infection - No other concurrent uncontrolled illness - No diabetes mellitus requiring insulin OR that required pharmacologic intervention for more than 5 years - No peripheral neuropathy grade 2 - No other serious medical or psychiatric illness that would preclude study compliance or treatment PRIOR CONCURRENT THERAPY: Biologic therapy - More than 8 weeks since prior antibody therapy and recovered Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No prior cumulative doxorubicin dose 180 mg/m^2 Endocrine therapy - At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) - Patients receiving luteinizing hormone-releasing hormone analog therapy for androgen suppression should continue this therapy throughout study participation Radiotherapy - More than 4 weeks since prior radiotherapy and recovered - More than 4 weeks since prior samarium Sm 153 lexidronam pentasodium - More than 12 weeks since prior strontium chloride Sr 89 Surgery - More than 4 weeks since prior major surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristopherLogothetis, , M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Christos Papandreou 713-792-2830
Additional Information:
Study ID Numbers: CDR0000355822; MDA-ID-02227,MILLENNIUM-MDA-ID-02227
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082680
Other Recurrent Prostate Cancer Studies:
1. Doxorubicin and Strontium-89 With or Without Celecoxib in Treating Patients With Progressive Androgen-Independent Prostate Cancer and Bone Metastases
2. SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
3. Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate
4. Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
5. Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Bortezomib and Mitoxantrone in Treating Patients With Advanced or Metastatic Androgen-Independent Prostate Cancer
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