Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer

NCT00004928 | Completed Phase 1

• 3 other identifiers: 99-073CDR0000067612NCI-H00-0048
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Calcitriol may help prostate cancer cells develop into normal cells. Zoledronate may delay or prevent the formation of bone metastases. Combining calcitriol and zoledronate may be an effective treatment for progressive prostate cancer. PURPOSE: Phase I trial to study the effectiveness of combining calcitriol with zoledronate in treating patients who have progressive prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer

Interventions

calcitriol DIETARY_SUPPLEMENT

zoledronic acid DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed prior localized adenocarcinoma of the prostate that has undergone definitive radiation or surgery and demonstrates progression biochemically with all of the following: * Baseline PSA at least 4 ng/mL * At least a 50% increase in PSA over at least 3 determinations taken at more than 2 week intervals * No radiographically evident disease * Neoadjuvant hormonal therapy prior to radical prostatectomy or radiotherapy allowed * Treatment in an intermittent approach allowed if off therapy for at least 12 weeks OR * Histologically confirmed androgen-independent adenocarcinoma of the prostate with all of the following: * Progression on primary hormonal treatment (e.g., orchiectomy, estrogen therapy, gonadotropin-releasing hormone analog with or without an antiandrogen) with either new osseous lesions in bone, a greater than 25% increase in bidimensionally measurable tumor mass, or rising PSA values (rising PSA on any 3 determinations taken at at least weekly intervals, to greater than 50% above baseline PSA) despite castrate levels of testosterone (no greater than 30 ng/mL) * If receiving antiandrogen as part of primary hormonal therapy, must meet criteria above for progression after discontinuation of antiandrogen * No change in hormonal therapy (including prednisone or dexamethasone) within the past 2 weeks * If no prior surgical orchiectomy, must continue on medical therapies to maintain castrate levels of testosterone * Prior chemotherapy, palliative radiotherapy, or radioisotope treatment allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL OR * SGOT less than 3 times upper limit of normal Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min * No history of nephrolithiasis * Must have 2 functioning kidneys Cardiovascular: * No New York Heart Association class III or IV heart disease Pulmonary: * No severe debilitating pulmonary disease Metabolic: * No pre-existing endocrine or metabolic disorders that impact calcium regulatory axis including hypercalcemia (ionized serum calcium greater than 5.3 mg/dL or total calcium greater than 10.5 mg/dL) or hypercalciuria (greater than 300 mg urinary calcium/24 hours) Other: * No active secondary malignancy except nonmelanoma skin cancer * Must maintain low calcium diet (less than 800 mg calcium daily) * No uncontrolled serious active infection * No history of malabsorption disorders * No history of inflammatory bowel disease PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy and recovered * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * Recovered from prior endocrine therapy Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy to sole measurable lesion Surgery: * See Disease Characteristics * Recovered from prior surgery * No concurrent surgery to sole measurable lesion Other: * No other concurrent cholecalciferol

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Calcitriol; Zoledronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michael Morris, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: May 14, 2003
• Study Start: October 1, 1999
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)