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Completed

NCT Number: NCT00182741

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

calcitriol

Dietary Supplement

mitoxantrone hydrochloride

Drug

Prednisone

Drug

Primary outcomes

  1. Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days

Secondary outcomes

  1. Toxicity as measured by Common Toxicity Criteria v3.0

  2. Frozen plasma and serum samples for correlative biomarker analysis collected every 21 days

  3. Confirmed PSA reduction > 75% measured every 21 days

  4. PSA normalization (< 4 ng/mL) measured every 21 days

  5. Response to measurable disease as measured by RECIST criteria every 9 weeks

  6. Analgesic response as measured by McGill-Melzack Pain Questionnaire every 21 days

  7. Analgesic medication use decreased by ≥ 50% without an increase in pain for 2 consecutive evaluations at least 3 weeks apart

  8. Palliative response as measured by McGill-Melzack Pain Questionnaire every 21 days

  9. Quality of life as measured by EORTC core questionnaire Quality of Life-C30 every 21 days

  10. Time to palliative-progression as measured by McGill-Melzack Pain Questionnaire every 21 days

  11. Time to PSA progression measured every 21 days

  12. Time to progression in measurable or evaluable disease as measured by whole body scan and/or CT or MRI scan every 9-12 weeks

  13. Time to death assessed every 6 months after completion of study treatment

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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