Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases - NCT00079001-87110 (Clinical Trial 119729)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy119729.aspx
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| City: |
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Albuquerque |
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State:
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NM |
| Zip Code: |
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87110 |
| Conditions: |
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Metastatic Cancer - Prostate Cancer |
| Purpose: |
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RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain
or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet
known whether treatment with zoledronate is effective in preventing bone-related events in
patients who have prostate cancer and bone metastases.
PURPOSE: This randomized phase III trial is studying how well zoledronate works in
preventing bone-related events in patients who are receiving androgen deprivation therapy
for prostate cancer and bone metastases.
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| Study summary: |
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OBJECTIVES:
Primary
- Compare the time to first skeletal-related events in patients with prostate cancer and
bone metastases undergoing androgen deprivation therapy when treated with zoledronate
vs placebo.
Secondary
- Compare the overall and progression-free survival of patients treated with these
regimens.
- Compare the toxic effects in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study followed
by an open-label study. Patients are stratified according to ECOG performance status (0-1 vs
2), prior skeletal-related event (no vs yes), and serum alkaline phosphatase (< upper limit
of normal [ULN] vs ≥ ULN). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive zoledronate IV over 15 minutes on day 1.
- Arm II: Patients receive placebo IV over 15 minutes on day 1. In both arms, courses
repeat every 4 weeks in the absence of disease progression or a skeletal-related event.
All patients receive concurrent androgen deprivation therapy. Patients also receive
oral calcium and cholecalciferol (vitamin D) supplements daily.
Patients progressing to androgen-independent prostate cancer proceed to open-label therapy
comprising zoledronate IV over 15 minutes on day 1. Courses repeat every 3 weeks in the
absence of disease progression or a skeletal-related event.
Patients are followed periodically for approximately 10 years after randomization.
PROJECTED ACCRUAL: A total of 680 patients (340 per treatment arm) will be accrued for this
study within 4 years. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- No small cell, neuroendocrine, or transitional cell carcinomas
- At least 1 bone metastasis by bone scan, MRI, CT scan, or plain radiographs
- Indeterminate lesions should be confirmed by a second imaging method
- At least 1 bone metastasis with no prior irradiation
- Concurrent androgen deprivation therapy required, defined as any of the following:
- Bilateral orchiectomy
- Gonadotropin-releasing hormone (GnRH) agonist with or without an antiandrogen
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Creatinine clearance ≥ 30 mL/min
- Corrected calcium ≥ 8.0 mg/dL and < 11.6 mg/dL
Other
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Concurrent standard biologic response modifiers allowed during open-label therapy
only
Chemotherapy
- Concurrent standard cytotoxic chemotherapy allowed during open-label therapy only
Endocrine therapy
- See Disease Characteristics
- Prior neoadjuvant and/or adjuvant hormonal therapy allowed provided duration of
therapy was no more than 6 months AND therapy was discontinued more than 6 months
before study entry
- No more than 6 months since initiation of any of the following hormonal therapies:
- Orchiectomy
- GnRH agonist (e.g., leuprolide, goserelin, or triptorelin)
- Estrogen therapy
- Antiandrogens (e.g., bicalutamide, flutamide, or nilutamide)
- Any other therapy known to lower testosterone levels or inhibit testosterone
effect
- No intermittent androgen deprivation therapy except for patients concurrently
enrolled on SWOG-9346
- Concurrent palliative corticosteroids allowed during open-label therapy only
- Concurrent standard hormonal agents allowed during open-label therapy only
Radiotherapy
- See Disease Characteristics
- No prior radiopharmaceuticals
- At least 4 weeks since prior radiotherapy
- Concurrent standard radiotherapy to extraskeletal and/or skeletal tumor sites allowed
during open-label therapy only
Surgery
- See Disease Characteristics
Other
- No prior bisphosphonates
- No other concurrent agents expected to alter osteoclast activity (e.g., calcitonin,
mithramycin, gallium nitrate, or any other bisphosphonate)
- Concurrent daily supplemental elemental calcium (500 mg) and a multivitamin
containing cholecalciferol (Vitamin D) (400 IU) OR a combination tablet containing
both recommended
- Concurrent standard marketed antineoplastic therapies allowed during open-label
therapy only |
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| Study is available at: |
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Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
Albuquerque, NM 87110
United States
Primary Contact:
Ian Rabinowitz, MD
Phone: 505-272-4551 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 3, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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