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Home > "C" Clinical Trials Conditions > Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy  Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: stage 3 prostate cancer,recurrent prostate cancer,stage 4 prostate cancer,adenocarcinoma of the prostate
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Pittsburgh Cancer Institute
Synopsis: 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.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of calcitriol administered alone and in combination with dexamethasone in patients with hormone-refractory prostate cancer. II. Determine the pharmacokinetics of calcitriol with and without dexamethasone in these patients. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GurkamalChatta, Study Chair, University of Pittsburgh Cancer Institute
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Additional Information:
Study ID Numbers: CDR0000068457; UPITTS-99044,UPITTS-IRB-990606
Study Start Date: June 1999
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010231
Other Recurrent Prostate Cancer Studies:
1. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
2. 3-AP in Treating Patients With Advanced Prostate Cancer
3. Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer
4. Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
5. Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
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