Clinical trial · Interventional
MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer
NCT00027781CI-TRIAL-00007550completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of MEN-10755 in treating patients who have progressive prostate cancer that has not responded 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sabarubicin | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed hormone-refractory adenocarcinoma of the prostate * Disease progression while on prior luteinizing hormone-releasing hormone (LHRH) analogues or after orchiectomy and antiandrogens, given concurrently or consecutively * Disease progression is defined as PSA progression documented by increases in PSA recorded at 2 consecutive measurements over a prior reference value * Interval of at least 1 week between the reference value and the first of these two PSA increases * Continued elevation of PSA for at least 6 weeks after discontinuation of antiandrogens * Last PSA value at least 5 ng/mL (Hybritech equivalent) * Must have serum testosterone less than 50 ng/mL and must continue on LHRH agonist therapy if no prior surgical castration * No symptomatic brain or leptomeningeal metastatic disease PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * ALT/AST no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal: * Creatinine no greater than 1.7 mg/dL * No uncontrolled hypercalcemia Cardiovascular: * No history of severe heart disease * No myocardial infarction within the past 6 months * No cardiac insufficiency * Normal cardiac function by MUGA scan and 12-lead EKG Other: * No other prior or concurrent malignancy except basal cell or squamous cell skin cancer * No uncontrolled systemic nonmalignant disease or infection * No psychological, familial, or geographical conditions that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy Endocrine therapy: * See Disease Characteristics * No prior hormonal therapy except estramustine * No concurrent estramustine Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy (e.g., for painful bone metastases) Surgery: * See Disease Characteristics Other: * No other concurrent experimental drugs or investigational therapy
References
Publications (1)
- RESULTFiedler W, Tchen N, Bloch J, Fargeot P, Sorio R, Vermorken JB, Collette L, Lacombe D, Twelves C; EORTC new drug development group. A study from the EORTC new drug development group: open label phase II study of sabarubicin (MEN-10755) in patients with progressive hormone refractory prostate cancer. Eur J Cancer. 2006 Jan;42(2):200-4. doi: 10.1016/j.ejca.2005.07.030. Epub 2005 Dec 7. PMID 16337787