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

NCT ID: NCT00182741

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2006-08-31

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 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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

calcitriol

Intervention Type: DIETARY_SUPPLEMENT

mitoxantrone hydrochloride

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Christopher Ryan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher W. Ryan, MD

Role: STUDY_CHAIR

OHSU Knight Cancer Institute

Locations

Cancer Institute at Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

References

Chan JS, Beer TM, Quinn DI, Pinski JK, Garzotto M, Sokoloff M, Dehaze DR, Ryan CW. A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer. BJU Int. 2008 Dec;102(11):1601-6. doi: 10.1111/j.1464-410X.2008.08017.x. Epub 2008 Sep 8.

Reference Type: RESULT

PMID: 18782306 (View on PubMed)

Other Identifiers

OHSU-8451

Identifier Type: -

Identifier Source: secondary_id

OHSU-VA-IRB-9451

Identifier Type: -

Identifier Source: secondary_id

CDR0000441172

Identifier Type: -

Identifier Source: org_study_id