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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Christopher W. Ryan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000441172

NCT ID:

NCT00182741

Start Date:

September 2004

Completion Date:

August 2006

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098