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


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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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 InstitutePittsburgh, Pennsylvania  15213