Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer - Full Text View

Sponsor:	OHSU Knight Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:	NCT00182741

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Dietary Supplement: calcitriol Drug: mitoxantrone hydrochloride Drug: prednisone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Calcitriol Mitoxantrone Mitoxantrone hydrochloride

U.S. FDA Resources

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:

Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity as measured by Common Toxicity Criteria v3.0 [ Designated as safety issue: Yes ]
Frozen plasma and serum samples for correlative biomarker analysis collected every 21 days [ Designated as safety issue: No ]
Confirmed PSA reduction > 75% measured every 21 days [ Designated as safety issue: No ]
PSA normalization (< 4 ng/mL) measured every 21 days [ Designated as safety issue: No ]
Response to measurable disease as measured by RECIST criteria every 9 weeks [ Designated as safety issue: No ]
Analgesic response as measured by McGill-Melzack Pain Questionnaire every 21 days [ Designated as safety issue: No ]
Analgesic medication use decreased by ≥ 50% without an increase in pain for 2 consecutive evaluations at least 3 weeks apart [ Designated as safety issue: No ]
Palliative response as measured by McGill-Melzack Pain Questionnaire every 21 days [ Designated as safety issue: No ]
Quality of life as measured by EORTC core questionnaire Quality of Life-C30 every 21 days [ Designated as safety issue: No ]
Time to palliative-progression as measured by McGill-Melzack Pain Questionnaire every 21 days [ Designated as safety issue: No ]
Time to PSA progression measured every 21 days [ Designated as safety issue: No ]
Time to progression in measurable or evaluable disease as measured by whole body scan and/or CT or MRI scan every 9-12 weeks [ Designated as safety issue: No ]
Time to death assessed every 6 months after completion of study treatment [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	September 2004
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182741

Locations

United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098

Sponsors and Collaborators

OHSU Knight Cancer Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Christopher W. Ryan, MD

OHSU Knight Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2008 Sep 8.

Responsible Party:	OHSU Knight Cancer Institute ( Christopher W. Ryan, MD )
Study ID Numbers:	CDR0000441172, OHSU-8451, OHSU-VA-IRB-9451
Study First Received:	September 15, 2005
Last Updated:	October 2, 2009
ClinicalTrials.gov Identifier:	NCT00182741 History of Changes
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:

recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Prostatic Diseases
Genital Neoplasms, Male
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Bone Density Conservation Agents
Hormones
Calcitriol
Membrane Transport Modulators
Neoplasms by Site

Sensory System Agents
Vitamins
Therapeutic Uses
Vasoconstrictor Agents
Micronutrients
Analgesics
Antineoplastic Agents, Hormonal
Growth Substances
Cardiovascular Agents
Genital Diseases, Male
Glucocorticoids
Pharmacologic Actions
Neoplasms
Peripheral Nervous System Agents
Mitoxantrone

ClinicalTrials.gov processed this record on February 08, 2010