Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI OHSU-6218 OHSU-HOR-00059-L, NCI-G01-1963, NCT00017576

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.

Entry 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

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

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 contraception

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Oregon Health and Science University Cancer Institute

Tomasz Beer, MD, Protocol chair		Ph: 503-494-3253; 800-494-1234

Registry Information
Official Title		Phase II Study of Calcitrol Enhanced Carboplatin in Hormone Refractory Prostate Cancer
Trial Start Date		2000-12-08
Registered in ClinicalTrials.gov		NCT00017576
Date Submitted to PDQ		2001-05-08
Information Last Verified		2002-06-01
NCI Grant/Contract Number		CA69533