Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 to 100 NCI OHSU-8451 OHSU-VA-IRB-9451, NCT00182741

Objectives

Primary

1. 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

1. Determine the safety and tolerability of this regimen in these patients.

Entry 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

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

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

Expected Enrollment

A total of 48 patients will be accrued for this study.

Outcomes

Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days

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
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

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.

Trial Contact Information

Trial Lead Organizations

Oregon Health and Science University Cancer Institute

Christopher Ryan, MD, Protocol chair		Ph: 503-494-8487; 800-494-1234 Email: ryanc@ohsu.edu

Registry Information
Official Title		Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)
Trial Start Date		2004-09-03
Registered in ClinicalTrials.gov		NCT00182741
Date Submitted to PDQ		2005-07-18
Information Last Verified		2006-08-15
NCI Grant/Contract Number		CA69533

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