RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Calcitriol may help carboplatin kill more cancer cells by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of carboplatin plus calcitriol in treating patients who have stage IV prostate cancer cancer that has not responded to hormone therapy.

Condition	Treatment or Intervention	Phase
stage IV prostate cancer adenocarcinoma of the prostate recurrent prostate cancer	Procedure: chemotherapy  Procedure: biological response modifier therapy  Drug: chemosensitization/potentiation  Procedure: differentiation therapy  Drug: calcitriol  Drug: carboplatin	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL 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

Oregon
      Oregon Cancer Institute, Portland,  Oregon,  97201-3098,  United States

Study chairs or principal investigators

Tomasz M Beer,  Study Chair,  Oregon Health and Science University   

Study ID Numbers:  CDR0000068720; OHSU-6218; NCI-G01-1963; OHSU-HOR-00059-L
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00017576
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08