Status:
COMPLETED
Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
PHASE2
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 diffe...
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-i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00182741
Start Date
September 1 2004
End Date
August 1 2006
Last Update
May 3 2017
Active Locations (1)
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1
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098