Clinical trial · Interventional
S0355 Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
A Phase I Pharmacokinetic Study Of Epothilone B Analogue BMS-247550 (NSC 710428D) In Patients With Advanced Malignancies And Varying Levels Of Liver Dysfunction
NCT00049400CI-TRIAL-00017377completedPhase 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 work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in treating patients with advanced solid tumors or lymphomas and liver dysfunction.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-247550 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment
- description
- Single-arm, dose-escalation of BMS-247550
- interventionNames
- Drug: BMS-247550
Primary outcomes (1)
- measure
- dose defining
- timeFrame
- Treatment delays >2 weeks constitute a DLT
Secondary outcomes (2)
- measure
- Progression
- timeFrame
- 30 days after going off study
- description
- 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective * Pathological confirmation of diagnosis not required in patients with liver mass, raised alpha-fetoprotein levels (at least 500 ng/mL), and positive serology for hepatitis consistent with a diagnosis of hepatocellular carcinoma * Any solid tumor or lymphoma tumor type eligible * Must have had thoracic and upper abdominal CT scan, including entire liver and adrenals, within 28 days before study entry * Patients with glioma or brain metastases must be on a stable dose of corticosteroids and be seizure-free for the past month * Prior whole brain or gamma knife radiotherapy required for known brain metastases * No unstable or untreated (non-irradiated) brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No active hemolysis Hepatic * See Disease Characteristics * Patients with biliary obstruction for which a shunt has been placed are allowed if shunt is in place for at least 10 days and liver function is stable * Abnormal liver function (bilirubin and SGOT) allowed regardless of cause (metastases or other causes) * No evidence of biliary sepsis Renal * Creatinine no greater than 1.5 mg/dL Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * No concurrent uncontrolled illness * No ongoing or active infection * No uncontrolled diarrhea * No peripheral neuropathy grade II or greater * No psychiatric illness or social situation that would preclude study compliance * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy for malignancy Chemotherapy * More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No other concurrent chemotherapy for malignancy Endocrine therapy * See Disease Characteristics * No concurrent oral contraceptives * No concurrent hormone therapy for malignancy * Concurrent luteinizing hormone-releasing hormone agonists allowed Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy for malignancy Surgery * More than 2 weeks since prior major surgery Other * Recovered from prior therapy * No concurrent medications that are known to be inhibitors of CYP3A4
References
Publications (1)
- RESULTTakimoto CH, Liu PY, Lenz H, et al.: A phase I pharmacokinetic (PK) study of the epothilone B analogue, ixabepilone (BMS-247550) in patients (pts) with advanced malignancies and varying degrees of hepatic impairment. A SWOG Early Therapeutics Committee and NCI Organ Dysfunction Working Group Trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-2004, 2006.