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

Alternate Title

Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	PCI-99044 PCI-IRB-990606, NCT00010231

Objectives

1. Determine the maximum tolerated dose of calcitriol administered alone and in combination with dexamethasone in patients with hormone-refractory prostate cancer.
2. Determine the pharmacokinetics of calcitriol with and without dexamethasone in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the prostate with progressing regional or metastatic disease despite primary hormonal therapy (bilateral orchiectomy, estrogen, or luteinizing hormone-releasing hormone (LHRH) therapy with or without simultaneous antiandrogen)



• Documented new lesions or rising PSA (at least 50% increase on 3 measurements more than 2 weeks apart) after prior antiandrogen or progestational agent, or other hormonal agent cessation

Prior/Concurrent Therapy:

Biologic therapy:

• Concurrent epoetin alfa for anemia allowed

Chemotherapy:

• Not specified

Endocrine therapy:

• See Disease Characteristics
• At least 28 days since prior antiandrogens or progestational agents
• Concurrent testicular androgen suppression with an LHRH analog (leuprolide or goserelin) allowed in non-orchidectomized patients

Radiotherapy:

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• No concurrent bisphosphonates

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,500/mm³
• Absolute neutrophil count greater than 1,500/mm³
• Platelet count greater than 100,000/mm³

Hepatic:

• Bilirubin less than 2.0 mg/dL
• SGOT less than 4 times upper limit of normal

Renal:

• Creatinine no greater than 1.8 mg/dL

Other:

• No uncontrolled diabetes mellitus
• Fertile patients must use effective double barrier contraception for at least 1 week before, during, and at least 2 weeks after study participation

Expected Enrollment

Approximately 40 patients will be accrued for this study.

Outline

This is a dose-escalation study of calcitriol.

In the first stage of the study, cohorts of 3-6 patients receive escalating doses of oral calcitriol on days 1-3. Dose escalation continues until the maximum tolerated dose (MTD) is determined.

In the second stage, patients receive escalating doses of oral calcitriol on days 1-3 and a fixed dose of oral dexamethasone on days 0-4. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Dose escalation continues until the MTD is determined.

Six additional patients may receive calcitriol and dexamethasone at one dose level below the MTD determined in the second stage, to confirm the MTD.

The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Trial Contact Information

Trial Lead Organizations

UPMC Cancer Centers

Gurkamal Chatta, MD, Protocol chair		Ph: 412-648-6619

Registry Information
Official Title		Phase I Study Of Oral, 1,25 dihydroxycholecalciferol (calcitriol) + dexamethasone In hormone-refractory prostate cancer
Trial Start Date		1999-06-24
Registered in ClinicalTrials.gov		NCT00010231
Date Submitted to PDQ		2001-01-02
Information Last Verified		2003-03-21
NCI Grant/Contract Number		P30-CA47904

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