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Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00017576
Recruitment Status : Completed
First Posted : January 8, 2004
Last Update Posted : April 28, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Tom Beer, OHSU Knight Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Calcitriol may help carboplatin kill more cancer cells by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of carboplatin plus calcitriol in treating patients who have prostate cancer that has not responded to hormone therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: calcitriol Drug: carboplatin Phase 2

Detailed Description:

OBJECTIVES: I. Determine the response in patients with androgen-independent prostate cancer treated with calcitriol and carboplatin. II. Determine the palliative response in patients with cancer-related pain treated with this regimen. III. Determine the response in patients with bidimensionally measurable disease treated with this regimen. IV. Determine the duration of prostate-specific antigen, palliative, and measurable disease responses in patients treated with this regimen. V. Determine the survival of patients treated with this regimen. VI. Assess the quality of life of patients treated with this regimen. VII. Determine the qualitative and quantitative toxic effects of this regimen in these patients.

OUTLINE: Patients receive oral calcitriol on day 1 and carboplatin IV over 60 minutes on day 2. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline and then every 4 weeks until disease progression. Patients are followed every 4 weeks until disease progression and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Calcitrol Enhanced Carboplatin in Hormone Refractory Prostate Cancer
Study Start Date : December 2000
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. PSA response rate defined as 50% decrease from baseline, confirmed on a second measurement 4 weeks later

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the prostate Stage IV Evidence of progression despite standard hormonal management including antiandrogen withdrawal, defined as 1 of the following: Development of new metastatic lesions Increase in cancer-related pain A 50% rise in prostate-specific antigen (PSA) levels confirmed by 2 measurements at least 2 weeks apart PSA at least 5 ng/mL Testosterone less than 50 ng/mL

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 1.3 mg/dL Calcium no greater than 10.5 mg/dL Phosphorus no greater than 4.2 mg/dL No kidney stones within the past 5 years No history of cancer-related hypercalcemia Cardiovascular: No uncontrolled heart failure Other: No other malignancy within the past 5 years except nonmelanoma skin cancer No significant active medical illness that would preclude study Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 type of prior chemotherapy for prostate cancer No prior carboplatin or cisplatin for prostate cancer Endocrine therapy: See Disease Characteristics At least 4 weeks since prior flutamide or nilutamide (6 weeks for bicalutamide) Concurrent primary hormonal therapy allowed (e.g., gonadotropin-releasing hormone agonist or antagonist) Radiotherapy: At least 1 month since prior radiotherapy At least 2 months since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium Surgery: Concurrent orchiectomy allowed Other: At least 7 days since prior thiazide diuretic At least 30 days since prior investigational therapy No prior calcitriol for prostate cancer No concurrent magnesium-containing antacids, bile-resin binders, or calcium supplements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00017576

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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97201-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
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Study Chair: Tomasz M. Beer, MD OHSU Knight Cancer Institute

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Responsible Party: Tom Beer, Principal Investigator, OHSU Knight Cancer Institute Identifier: NCT00017576     History of Changes
Other Study ID Numbers: CDR0000068720
First Posted: January 8, 2004    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Keywords provided by Tom Beer, OHSU Knight Cancer Institute:
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents