Phase I Study Of Oral, 1,25 Dihydroxycholecalciferol (Calcitriol) + Dexamethasone In Hormone-refractory Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
Phase I Study Of Oral, 1,25 Dihydroxycholecalciferol (Calcitriol) + Dexamethasone In Hormone-refractory Prostate Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Gurkamal S. Chatta, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Pittsburgh
Authority:
United States: Federal Government
Study ID:
CDR0000068457
NCT ID:
NCT00010231
Start Date:
June 1999
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage III prostate cancer
- stage IV prostate cancer
- recurrent prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
