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Phase II Study of Calcitrol Enhanced Carboplatin in Hormone Refractory Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Phase II Study of Calcitrol Enhanced Carboplatin in Hormone Refractory Prostate Cancer

OBJECTIVES: I. Determine the response in patients with androgen-independent prostate cancer
treated with calcitriol and carboplatin. II. Determine the palliative response in patients
with cancer-related pain treated with this regimen. III. Determine the response in patients
with bidimensionally measurable disease treated with this regimen. IV. Determine the
duration of prostate-specific antigen, palliative, and measurable disease responses in
patients treated with this regimen. V. Determine the survival of patients treated with this
regimen. VI. Assess the quality of life of patients treated with this regimen. VII.
Determine the qualitative and quantitative toxic effects of this regimen in these patients.

OUTLINE: Patients receive oral calcitriol on day 1 and carboplatin IV over 60 minutes on day
2. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease
progression. Quality of life is assessed at baseline and then every 4 weeks until disease
progression. Patients are followed every 4 weeks until disease progression and then every 3
months thereafter.

PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the
prostate Stage IV Evidence of progression despite standard hormonal management including
antiandrogen withdrawal, defined as 1 of the following: Development of new metastatic
lesions Increase in cancer-related pain A 50% rise in prostate-specific antigen (PSA)
levels confirmed by 2 measurements at least 2 weeks apart PSA at least 5 ng/mL
Testosterone less than 50 ng/mL

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At
least 3 months Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal:
Creatinine no greater than 1.3 mg/dL Calcium no greater than 10.5 mg/dL Phosphorus no
greater than 4.2 mg/dL No kidney stones within the past 5 years No history of
cancer-related hypercalcemia Cardiovascular: No uncontrolled heart failure Other: No other
malignancy within the past 5 years except nonmelanoma skin cancer No significant active
medical illness that would preclude study Fertile patients must use effective

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1
type of prior chemotherapy for prostate cancer No prior carboplatin or cisplatin for
prostate cancer Endocrine therapy: See Disease Characteristics At least 4 weeks since
prior flutamide or nilutamide (6 weeks for bicalutamide) Concurrent primary hormonal
therapy allowed (e.g., gonadotropin-releasing hormone agonist or antagonist) Radiotherapy:
At least 1 month since prior radiotherapy At least 2 months since prior strontium chloride
Sr 89 or samarium Sm 153 lexidronam pentasodium Surgery: Concurrent orchiectomy allowed
Other: At least 7 days since prior thiazide diuretic At least 30 days since prior
investigational therapy No prior calcitriol for prostate cancer No concurrent
magnesium-containing antacids, bile-resin binders, or calcium supplements

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA response rate defined as 50% decrease from baseline, confirmed on a second measurement 4 weeks later

Safety Issue:


Principal Investigator

Tomasz M. Beer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute


United States: Federal Government

Study ID:




Start Date:

December 2000

Completion Date:

July 2006

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



OHSU Knight Cancer Institute Portland, Oregon  97239