Clinical trial · Interventional
BMS-247550 in Treating Patients With Liver or Gallbladder Cancer
A Phase II Trial Of The Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Hepatobiliary Cancer
NCT00023946CI-TRIAL-00014520terminatedPhase 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)
Phase II trial to study the effectiveness of BMS-247550 in treating patients who have liver or gallbladder cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Primary Cholangiocellular Carcinoma | Adult Cholangiocarcinoma | ALIAS | 0.90 |
| Adult Primary Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ALIAS | 0.90 |
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Cholangiocarcinoma of the Extrahepatic Bile Duct | — | UNRESOLVED | — |
| Cholangiocarcinoma of the Gallbladder | — | UNRESOLVED | — |
| Localized Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | CURATED_BROADER | 0.78 |
| Localized Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_BROADER | 0.78 |
| Localized Resectable Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Localized Unresectable Adult Primary Liver Cancer |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ixabepilone | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (ixabepilone)
- description
- Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: ixabepilone
- Other: laboratory biomarker analysis
Primary outcomes (4)
- measure
- Objective response rate (partial or complete response) evaluated by RECIST
- timeFrame
- Up to 8 years
- description
- A 10% response rate precludes further study whereas a 25% response rate would indicate that further study is warranted.
- measure
- Frequency and extent of cytotoxic activity graded according to the NCI CTC Version 2.0
- timeFrame
- Up to 8 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically or cytologically confirmed locally advanced, metastatic, or recurrent hepatobiliary cancer
* Liver (hepatocellular)
* Bile duct (cholangiocarcinoma)
* Gallbladder
* At least 1 unidimensionally measurable lesion
* At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* The following are not considered measurable lesions:
* Lesions seen on colonoscopic examination or barium studies
* Bone metastases
* CNS lesions
* Ascites
* No brain metastases
* Performance status - ECOG 0-2
* At least 3 months
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* AST/ALT no greater than 2.5 times upper limit of normal
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No grade 2 or greater peripheral neuropathy
* No other uncontrolled concurrent illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No prior allergic hypersensitivity reaction attributed to compounds containing Cremophor EL (e.g., paclitaxel or compounds of similar chemical or biological composition to BMS-247550)
* No other currently active malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer for which patient has completed therapy and is at less than 30% risk of relapse
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent immunotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
* No concurrent hormonal therapy
* No concurrent therapeutic radiotherapy
* At least 30 days since prior investigational agents
* At least 7 days since prior cimetidine
* No concurrent cimetidine
* No other concurrent commercial or investigational anticancer agents or therapies
* No concurrent unconventional therapies, food, or vitamin supplements (e.g., St. John's Wort)
* No concurrent combination antiretroviral therapy for HIV-positive patientsReferences
Publications (0)
Data not yet available
No reference posted for this study.