Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer
This study has been completed.
Sponsor:
OHSU Knight Cancer Institute
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00182741
First received: September 15, 2005
Last updated: May 24, 2012
Last verified: October 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Dietary Supplement: calcitriol Drug: mitoxantrone hydrochloride Drug: prednisone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC) |
Resource links provided by NLM:
Further study details as provided by OHSU Knight Cancer Institute:
Primary Outcome Measures:
- Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity as measured by Common Toxicity Criteria v3.0 [ Designated as safety issue: Yes ]
- Frozen plasma and serum samples for correlative biomarker analysis collected every 21 days [ Designated as safety issue: No ]
- Confirmed PSA reduction > 75% measured every 21 days [ Designated as safety issue: No ]
- PSA normalization (< 4 ng/mL) measured every 21 days [ Designated as safety issue: No ]
- Response to measurable disease as measured by RECIST criteria every 9 weeks [ Designated as safety issue: No ]
- Analgesic response as measured by McGill-Melzack Pain Questionnaire every 21 days [ Designated as safety issue: No ]
- Analgesic medication use decreased by ≥ 50% without an increase in pain for 2 consecutive evaluations at least 3 weeks apart [ Designated as safety issue: No ]
- Palliative response as measured by McGill-Melzack Pain Questionnaire every 21 days [ Designated as safety issue: No ]
- Quality of life as measured by EORTC core questionnaire Quality of Life-C30 every 21 days [ Designated as safety issue: No ]
- Time to palliative-progression as measured by McGill-Melzack Pain Questionnaire every 21 days [ Designated as safety issue: No ]
- Time to PSA progression measured every 21 days [ Designated as safety issue: No ]
- Time to progression in measurable or evaluable disease as measured by whole body scan and/or CT or MRI scan every 9-12 weeks [ Designated as safety issue: No ]
- Time to death assessed every 6 months after completion of study treatment [ Designated as safety issue: No ]
| Enrollment: | 19 |
| Study Start Date: | September 2004 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182741
Locations
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
| Study Chair: | Christopher W. Ryan, MD | OHSU Knight Cancer Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00182741 History of Changes |
| Other Study ID Numbers: | CDR0000441172, OHSU-8451, OHSU-VA-IRB-9451 |
| Study First Received: | September 15, 2005 |
| Last Updated: | May 24, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by OHSU Knight Cancer Institute:
|
recurrent prostate cancer stage IV prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Calcitriol Mitoxantrone Prednisone Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Antineoplastic Agents Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on June 18, 2013