Clinical trial · Interventional
Estramustine, Docetaxel and Zoledronate Treatment in Hormone-Refractory Adenocarcinoma of the Prostate
An Evaluation of Estramustine, Docetaxel and Zoledronate in Patients With Hormone-Refractory Adenocarcinoma of the Prostate
NCT00151073CI-TRIAL-00016675completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Purpose: The aim of this clinical trail is to evaluate the effectiveness of Zoledronate (Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment of patients with hormone-refractory prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone-Refractory Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Estramustine | Drug | Estramustine | ALIAS |
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Zoledronate Alone
- description
- Zoledronate is given alone for the first cycle. All subsequent cycles consist of Docetaxel (70mg/m\^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2.
- interventionNames
- Drug: Zoledronic acid
- Drug: Estramustine
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- Docetaxel and Estramustine
- description
- Docetaxel and Estramustine are given for the first cycle of therapy. All subsequent cycles consist of Docetaxel (70mg/m\^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2.
- interventionNames
- Drug: Zoledronic acid
- Drug: Estramustine
- Drug: Docetaxel
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
All patients must have a histologic diagnosis of hormone-refractory adenocarcinoma of the prostate, and hormone refractory disease must be demonstrated by the appearance of new lesions on bone or CT scan and/or a rising PSA value. (No evidence of brain metastasis or untreated spinal cord compression.) Patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate a rising PSA 4 weeks after withdrawal from flutamide and 6 weeks after withdrawal from bicalutamide. Patient must not be undergoing current chemotherapy, biologic therapy, other investigational or alternative anti-cancer directed therapy or radiation therapy. Prior radiation therapy must have completed more than 4 weeks prior to registration. Patients may not have received prior taxane-based cytotoxic chemotherapy for hormone refractory disease.
References
Publications (0)
Data not yet available
No reference posted for this study.