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NCT00081159 · ClinicalTrials.gov registry record · Phase 2
Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT00081159: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00081159 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00081159, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and leuprolide may fight prostate cancer by stopping the adrenal glands from producing androgens. Drugs used in chemotherapy such as doxorubicin work in different ways to stop tumor cells from dividing so they stop growing or die. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. Radioactive substances such as strontium-89 may relieve bone pain associated with prostate cancer. It is not yet known whether hormone (androgen) ablation therapy and chemotherapy combined with zoledronate is more effective with or without strontium-89 in treating prostate cancer and bone metastases. PURPOSE: This randomized phase II trial is studying giving hormone ablation therapy, doxorubicin, and zoledronate together with strontium-89 to see how well it works compared to hormone ablation therapy, doxorubicin, and zoledronate alone in treating patients with androgen-dependent prostate cancer and bone metastases.
Interventions
- DRUG Leuprolide acetate
- DRUG Zoledronic acid
- DRUG Doxorubicin hydrochloride
- DRUG Goserelin acetate
- PROCEDURE orchiectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2004-07 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00081159
The ClinicalTrials.gov registry entry for NCT00081159 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Leuprolide acetate is the first listed.
NCT00081159 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00081159 about?
NCT00081159 is a clinical study titled "Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases". RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and leuprolide may fight prostate cancer by stopping the adrenal glands from producing androgens. Drugs used in chemotherapy such as doxorubicin work in different ways to stop tumor cells from dividing so...
What is the current status of trial NCT00081159?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2004-07. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00081159?
The interventions under investigation include: Leuprolide acetate (DRUG), Zoledronic acid (DRUG), Doxorubicin hydrochloride (DRUG), Goserelin acetate (DRUG), orchiectomy (PROCEDURE).
Who is sponsoring clinical trial NCT00081159?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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