Expired Study
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Pittsburgh, Pennsylvania 15213


Purpose:

RATIONALE: Combining calcitriol with dexamethasone may increase the effectiveness of therapy by making cancer cells more sensitive to dexamethasone. PURPOSE: Phase I trial to study the effectiveness of calcitriol combined with dexamethasone in treating patients who have prostate cancer that has not responded to previous hormone therapy.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of calcitriol administered alone and in combination with dexamethasone in patients with hormone-refractory prostate cancer. - Determine the pharmacokinetics of calcitriol with and without dexamethasone in these patients. 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. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.


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 PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,500/mm^3 - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 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 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


Study is Available At:


Original ID:

PCI-99044


NCT ID:

NCT00010231


Secondary ID:

CDR0000068457


Study Acronym:


Brief Title:

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


Official Title:

Phase I Study Of Oral, 1,25 Dihydroxycholecalciferol (Calcitriol) + Dexamethasone In Hormone-refractory Prostate Cancer


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

  • United States: Federal Government
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

22


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gurkamal S. Chatta, MD
Study Chair
University of Pittsburgh

Study Dates

Start Date:June 1999
Completion Date:November 2002
Completion Type:Actual
Primary Completion Date:August 2002
Primary Completion Type:Actual
Verification Date:March 2015
Last Changed Date:March 27, 2015
First Received Date:February 2, 2001

Study Outcomes

Outcome Type:Secondary Outcome
Measure:effects of calcitriol +/- dexamethasone on serum PTH, urinary calcium and MAPK activity and VDR expression in serum, urine and PBMs , respectively, in this patient population
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:pharmacokinetics of calcitriol when given as a single agent and following 3 days of dexamethasone
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:whether dexamethasone permits the administration of calcitriol without the development of hypercalcemia in patients who developed hypercalcemia while receiving calcitriol alone
Time Frame:1 year
Safety Issues:False
Outcome Type:Primary Outcome
Measure:MTD of calcitriol (oral, MTW weekly + dexamethasone (oral, Sunday, Monday, Tuesday, Wednesday - SMTW) in men with hormone refractory prostate cancer
Time Frame:1 year
Safety Issues:False
Outcome Type:Primary Outcome
Measure:MTD of calcitriol (oral) administered for 3 days (Monday, Tuesday, Wednesday -MTW) weekly in men with hormone-refractory prostate cancer
Time Frame:1 year
Safety Issues:False

Study Interventions

Intervention Type:Dietary Supplement
Name:calcitriol
Intervention Type:Drug
Name:dexamethasone

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pittsburgh
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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