Prostate Cancer
Conditions
Keywords
recurrent prostate cancer, stage IV prostate cancer
Brief summary
RATIONALE: Calcitriol may cause prostate cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as mitoxantrone and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well giving calcitriol together with mitoxantrone and prednisone works in treating patients with metastatic prostate cancer.
Detailed description
OBJECTIVES: Primary * Determine the prostate-specific antigen (PSA) response rate, defined as the fraction of patients with 50% reduction in PSA level over 3 weeks' time, in patients with androgen-independent metastatic prostate cancer treated with high-dose pulse calcitriol, mitoxantrone, and prednisone. Secondary * Determine the safety and tolerability of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral high dose pulse calcitriol on day 1, mitoxantrone IV on day 2, and oral prednisone on days 1-21. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Interventions
DIETARY_SUPPLEMENTcalcitriol
DRUGmitoxantrone hydrochloride
DRUGprednisone
Sponsors
National Cancer Institute (NCI)
OHSU Knight Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer * Androgen-independent disease, defined as disease progression while on standard hormonal management, including antiandrogen withdrawal * Patients must continue primary hormonal therapy during study treatment * Regional or distant metastases * Prostate-specific antigen \> 5 ng/mL * No brain metastases PATIENT CHARACTERISTICS: Age * 18 to 100 Performance status * ECOG 0-3 Life expectancy * Not specified Hematopoietic * Adequate hematologic function Hepatic * Adequate hepatic function Renal * Adequate renal function * No calcium-salt kidney stones within the past 5 years * No hypercalcemia Cardiovascular * Adequate cardiac function * No significant cardiac disease * No atrial fibrillation Other * Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment * No other serious medical illness * No other active malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * More than 28 days since prior biologic therapy Chemotherapy * No prior chemotherapy Endocrine therapy * See Disease Characteristics Radiotherapy * No prior strontium chloride Sr 89 * More than 28 days since prior radiotherapy * More than 56 days since prior samarium Sm 153 lexidronam pentasodium Surgery * Prior prostatectomy and/or orchiectomy allowed Other * More than 28 days since prior investigational therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Frozen plasma and serum samples for correlative biomarker analysis collected every 21 days | — |
| Confirmed PSA reduction > 75% measured every 21 days | — |
| PSA normalization (< 4 ng/mL) measured every 21 days | — |
| Response to measurable disease as measured by RECIST criteria every 9 weeks | — |
| Analgesic response as measured by McGill-Melzack Pain Questionnaire every 21 days | — |
| Analgesic medication use decreased by ≥ 50% without an increase in pain for 2 consecutive evaluations at least 3 weeks apart | — |
| Toxicity as measured by Common Toxicity Criteria v3.0 | — |
| Quality of life as measured by EORTC core questionnaire Quality of Life-C30 every 21 days | — |
| Time to palliative-progression as measured by McGill-Melzack Pain Questionnaire every 21 days | — |
| Time to PSA progression measured every 21 days | — |
| Time to progression in measurable or evaluable disease as measured by whole body scan and/or CT or MRI scan every 9-12 weeks | — |
| Time to death assessed every 6 months after completion of study treatment | — |
| Palliative response as measured by McGill-Melzack Pain Questionnaire every 21 days | — |
Countries
United States
Outcome results
None listed