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

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ClinicalTrials.gov Identifier: NCT00182741
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Christopher Ryan, OHSU Knight Cancer Institute

Tracking Information
First Submitted Date  ICMJE September 15, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date May 3, 2017
Study Start Date  ICMJE September 2004
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2007)
Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00182741 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2007)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer
Official Title  ICMJE Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Dietary Supplement: calcitriol
  • Drug: mitoxantrone hydrochloride
  • Drug: prednisone
Study Arms  ICMJE Not Provided
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. doi: 10.1111/j.1464-410X.2008.08017.x. Epub 2008 Sep 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2009)
19
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00182741
Other Study ID Numbers  ICMJE CDR0000441172
OHSU-8451
OHSU-VA-IRB-9451
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christopher Ryan, OHSU Knight Cancer Institute
Study Sponsor  ICMJE OHSU Knight Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Christopher W. Ryan, MD OHSU Knight Cancer Institute
PRS Account OHSU Knight Cancer Institute
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP