Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Calcitriol may help tumor cells develop into normal cells. Dexamethasone may increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining calcitriol with dexamethasone in treating patients with prostate cancer who have undergone surgery or radiation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: BB 1101; Calcitriol; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate meeting all of the following criteria:

• Curatively treated with radical prostatectomy OR definitive radiotherapy

• No signs of clinical recurrence or dissemination of prostate cancer by digital rectal examination without tumor

• No local recurrence by CT scan or MRI of the pelvis

• No metastases by bone scan and chest x-ray NOTE: Prior Prostascint scans allowed regardless of results

• At least 3 prostate-specific antigen (PSA) measurements obtained over at least 90 days after radical prostatectomy on post-radiotherapy PSA nadir must be available

• PSA at least 2 ng/mL after prostatectomy OR at least 4 ng/mL after prior radiotherapy

• Patients previously treated with radiotherapy must have a PSA clearly rising from lowest value within 6 months after completion of therapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 12 months

Hematopoietic

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic

• Bilirubin no greater than upper limit of normal (ULN)

• Alkaline phosphatase no greater than 2 times ULN

Renal

• Creatinine less than 1.8 mg/dL

• Phosphorus normal

• No hypercalcemia (albumin-corrected calcium greater than ULN)

• No nephrolithiasis

• Single episode of renal lithiasis allowed provided episode occurred more than 5 years prior to study

Other

• Fertile patients must use effective double-barrier contraception for at least 1 week before, during, and for at least 2 weeks after study

• No symptomatic pancreatitis

• No uncontrolled diabetes

• No known or suspected inability to comply with study requirements (e.g., abuse of alcohol/drugs or psychotic states)

• Curatively treated condition associated with renal stones (e.g., hyperparathyroidism, bladder dysfunction, or obstructive uropathy) allowed provided patient has been free of stone formation for more than 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for prostate cancer

• At least 24 months since prior chemotherapy for other diseases

Endocrine therapy

• More than 6 months since prior hormonal therapy, including neoadjuvant or adjuvant androgen deprivation therapy (e.g., luteinizing hormone-releasing hormone analogue or antiandrogen)

• No prior androgen deprivation therapy of more than 8 months duration

• No prior hormonal therapy for prostate cancer more than 3 months after definitive local therapy

• No concurrent androgen therapy

Radiotherapy

• See Disease Characteristics

• More than 3 months since prior radiotherapy for locally recurrent prostate cancer

• No concurrent radiotherapy, including for pain control

Surgery

• See Disease Characteristics

Other

• More than 4 weeks since prior investigational drugs

• No concurrent medication known to affect systemic calcium metabolism, including any of the following:

• More than 400 IU of cholecalciferol supplements

• More than 500 IU of vitamin A supplements

• Calcium supplements

• Fluoride

• Antiepileptics