Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)
18 Years
N/A
Male
Prostate Cancer
Trial Information
Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)
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.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
Safety Issue:
No
Principal Investigator
Christopher W. Ryan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000441172
NCT ID:
NCT00182741
Start Date:
September 2004
Completion Date:
August 2006
Related Keywords:
- Prostate Cancer
- recurrent prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
