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| ID | Type | Description | Link |
|---|---|---|---|
| OHSU-8451 | |||
| OHSU-VA-IRB-9451 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcitriol | Dietary Supplement | |||
| mitoxantrone hydrochloride | Drug | |||
| prednisone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity as measured by Common Toxicity Criteria v3.0 | ||
| Frozen plasma and serum samples for correlative biomarker analysis collected every 21 days | ||
| Confirmed PSA reduction > 75% measured every 21 days |
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DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Androgen-independent disease, defined as disease progression while on standard hormonal management, including antiandrogen withdrawal
Regional or distant metastases
Prostate-specific antigen > 5 ng/mL
No brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Christopher W. Ryan, MD | OHSU Knight Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18782306 | Result | Chan JS, Beer TM, Quinn DI, Pinski JK, Garzotto M, Sokoloff M, Dehaze DR, Ryan CW. A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer. BJU Int. 2008 Dec;102(11):1601-6. doi: 10.1111/j.1464-410X.2008.08017.x. Epub 2008 Sep 8. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| D008942 | Mitoxantrone |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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| 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 |
| Palliative response as measured by McGill-Melzack Pain Questionnaire every 21 days |
| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |