Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: calcitriol (Drug); mitoxantrone hydrochloride (Drug); prednisone (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Oregon Health and Science University Cancer Institute Official(s) and/or principal investigator(s):
Christopher W. Ryan, MD, Study Chair, Affiliation: Oregon Health and Science University Cancer Institute
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.
Clinical Details
Official title: Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)
Study design: Treatment, Open Label
Primary outcome: Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
Secondary outcome: Toxicity as measured by Common Toxicity Criteria v3.0Frozen 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 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Cancer Institute at Oregon Health and Science University, Portland, Oregon 97239-3098, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: September 2004
Last updated: May 23, 2008
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