Clinical trial · Interventional
Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer
- 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, such as mitoxantrone, etoposide, and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which drug is more effective in killing tumor cells. PURPOSE: This randomized phase II trial is studying how well mitoxantrone works compared to etoposide or vinorelbine works as second-line therapy in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
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 |
|---|---|---|---|
| etoposide | Drug | Etoposide | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Palliative response rate
Secondary outcomes (8)
- measure
- Duration of palliative response
- measure
- Biological response
- measure
- Tumor response as assessed by RECIST criteria
- measure
- Time to progression
- measure
- Overall survival
- measure
- Quality of life as assessed by QLQ-PR25
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Metastatic progressive disease meeting the following criteria:
* Increase in measurable lesions \> 25%
* Increase in bone lesions \> 25%
* Biological progression rate of PSA \> 4 ng/mL
* Received docetaxel as first-line chemotherapy
* Received at least 1 prior regimen of hormone therapy
* Pain \> 2 on Visual Analog Scale or continuing level 2 analgesics
* No symptomatic or evolutionary CNS disease
PATIENT CHARACTERISTICS:
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 times normal
* Alkaline phosphatase ≤ 2 times normal (unless bone metastases are present)
* Transaminases ≤ 1.5 times normal
* Bilirubin ≤ 1.5 times normal
* No prior malignancy except basal cell skin cancer
* No peripheral neuropathy or severe neuropathy ≥ grade 2
* No other severe lung, hepatic, renal, or digestive disease that would be complicated by treatment
* LVEF \> 50%
* No history of peptic ulcer, unstable diabetes, or other contraindication to using steroids
* No severe infection requiring antibiotics
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 8 weeks since prior metabolic radiotherapy
* More than 4 weeks since prior external radiotherapy
* At least 1 month since prior docetaxel-based chemotherapy
* At least 1 month since prior antiandrogen therapy in the case of complete hormonal blockage
* No participation in another clinical trial within the past 30 daysReferences
Publications (0)
Data not yet available