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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00182741
First received: September 15, 2005
Last updated: May 24, 2012
Last verified: October 2009
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Christopher W. Ryan, MD OHSU Knight Cancer Institute
  More Information

Additional Information:
Publications:
Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00182741     History of Changes
Other Study ID Numbers: CDR0000441172, OHSU-8451, OHSU-VA-IRB-9451
Study First Received: September 15, 2005
Last Updated: May 24, 2012
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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Calcitriol
Mitoxantrone
Prednisone
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Antineoplastic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 22, 2014