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

Information source: OHSU Knight Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: calcitriol (Dietary Supplement); mitoxantrone hydrochloride (Drug); prednisone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: OHSU Knight Cancer Institute

Official(s) and/or principal investigator(s):
Christopher W. Ryan, MD, Study Chair, Affiliation: OHSU Knight 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: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

Toxicity as measured by Common Toxicity Criteria v3.0

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

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 24, 2012

Page last updated: August 23, 2015

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