Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Recruitment status was Active, not recruiting
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Dietary Supplement: calcitriol Drug: dexamethasone |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Study Of Oral, 1,25 Dihydroxycholecalciferol (Calcitriol) + Dexamethasone In Hormone-refractory Prostate Cancer |
| Study Start Date: | June 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213-3489 | |
| Study Chair: | Gurkamal S. Chatta, MD | University of Pittsburgh |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00010231 History of Changes |
| Other Study ID Numbers: | CDR0000068457, PCI-99044, PCI-IRB-990606 |
| Study First Received: | February 2, 2001 |
| Last Updated: | July 25, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the prostate stage III prostate cancer stage IV prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Calcitriol Dihydroxycholecalciferols Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Vitamins Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013