Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer
Treatment of Prostate Cancer by Induction of Alternate Cell Death Pathways: A Phase I Trial of Docetaxel, Estramustine, Mitoxantrone and Prednisone
NCT00003633CI-TRIAL-00013153unknownPhase 1ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with advanced 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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| estramustine phosphate sodium | Drug | Estramustine | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Failure of complete androgen ablation (orchiectomy or LHRH and antiandrogen therapy) as manifested by at least 1 of the following criteria: * Rise in serum PSA greater than 50% of nadir confirmed on 2 measurements 1 week apart * Appearance of new lesions on bone scan * Appearance of new soft-tissue lesions * Measurable or evaluable disease * No brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Greater than 3 months Hematopoietic: * WBC at least 3,500/mm3 * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * Alkaline phosphatase no greater than 5 times ULN * SGOT and SGPT no greater than 2 times ULN Renal: * Creatinine no greater than 2 times ULN Cardiovascular: * No history of coagulopathy * No myocardial infarction in the last 6 months * No history of cardiovascular accident * No history of congestive heart failure Neurological: * No symptomatic peripheral neuropathy greater than grade 1 * No history of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures Pulmonary: * No history of pulmonary embolus Other: * Testosterone no greater than 3.5 nmol/L * No contraindications to glucocorticoid therapy such as uncontrolled diabetes mellitus or active peptic ulcer disease * No active infection * No other serious illness or medical condition * No other concurrent or prior malignancy in the past 5 years except previously excised or curatively irradiated nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior hormonal therapy (including nonsteroidal antiandrogens, but not LHRH agonists) Radiotherapy: * No prior radiotherapy to greater than 30% of bone marrow * At least 6 weeks since isotope therapy * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics Other: * At least 4 weeks since prior investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.