Clinical trial · Interventional
BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients With Hormone Refractory Prostate Cancer
NCT00016393CI-TRIAL-00010970completedPhase 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 BMS-247550 in treating patients who have 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 |
|---|---|---|---|
| ixabepilone | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Stage D1 or D2 disease (T4, N0, M0; any T, N1-3, M0; or any T, any N, M1) * Unresponsive or refractory to prior hormonal therapy by at least 1 of the following: * Progression of unidimensionally measurable lesion outside of a prior radiation port * Progression of non-measurable disease (e.g., bone scan) * Rising prostate-specific antigen (PSA) on at least 2 consecutive measurements taken at least 7 days apart * PSA at least 5 ng/mL * No brain metastases PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * SGOT or SGPT no greater than 2.5 times ULN Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 40 mL/min Other: * No other malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, any carcinoma in situ, or stage I or II cancer in complete remission * No other concurrent significant active illness that would preclude study participation * Recovered from major infections * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 28 days since prior biologic therapy and recovered * No more than 1 prior biologic (non-cytotoxic) therapy * No concurrent biological response modifiers Chemotherapy: * No prior chemotherapy for this disease * No other concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * At least 28 days since prior flutamide or ketoconazole * At least 42 days since prior bicalutamide or nilutamide * No concurrent hormonal therapy, except luteinizing hormone-releasing hormone therapy * No concurrent corticosteroids Radiotherapy: * See Disease Characteristics * Prior radiotherapy to less than 30% of bone marrow allowed * No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium * At least 28 days since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * Recovered from prior surgery * Prior orchiectomy allowed Other: * No concurrent unconventional therapy (e.g., St. John's Wort, PC-SPES, or other herbal remedy for prostate cancer) * Not planning to begin bisphosphonate therapy (patients already receiving bisphosphonates are eligible provided they have progressive disease)
References
Publications (1)
- RESULTHussain M, Tangen CM, Lara PN Jr, Vaishampayan UN, Petrylak DP, Colevas AD, Sakr WA, Crawford ED; Southwest Oncology Group. Ixabepilone (epothilone B analogue BMS-247550) is active in chemotherapy-naive patients with hormone-refractory prostate cancer: a Southwest Oncology Group trial S0111. J Clin Oncol. 2005 Dec 1;23(34):8724-9. doi: 10.1200/JCO.2005.02.4448. PMID 16314632