Clinical trial · Interventional
BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Colorectal Cancer Previously Treated With A Fluoropyrimidine And Irinotecan
NCT00033306CI-TRIAL-00011596terminatedPhase 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 metastatic colorectal cancer.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluoropyrimidine | Drug | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
| ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BMS-247550
- interventionNames
- Drug: ixabepilone
- Drug: Fluoropyrimidine
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Determine the clinical activity of BMS-247550, as measured by the tumor response rate, in patients with metastatic colorectal cancer previously treated with a fluoropyrimidine and irinotecan.
- timeFrame
- baseline to survival
Secondary outcomes (2)
- measure
- Determine the safety of this drug in these patients.
- timeFrame
- baseline to survival
- measure
- Determine the response duration, time to progression, and survival in patients treated with this drug.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic colorectal adenocarcinoma
* Prior treatment for metastatic disease with at least:
* One regimen of irinotecan in combination with a fluoropyrimidine OR
* Two regimens comprising fluoropyrimidine-based first-line therapy and irinotecan-based second-line therapy
* May have received cetuximab and/or a fluoropyrimidine as part of second- line therapy
* Disease progression during or within 4 months of treatment with irinotecan
* At least 1 bidimensionally measurable lesion
* No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count greater than 125,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases present)
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No New York Heart Association class III or IV heart disease
* No history of unstable angina, myocardial infarction, or congestive heart failure within the past 6 months
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known prior severe hypersensitivity reactions to agents containing Cremophor EL
* No motor or sensory neuropathy grade 2 or greater
* No concurrent serious uncontrolled infection or other nonmalignant medical illness
* No concurrent psychiatric disorders or other conditions that would preclude study compliance
* No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* No concurrent immunotherapy
* No growth factors for 24 hours before and after cytotoxic chemotherapy
Chemotherapy:
* See Disease Characteristics
* Additional prior adjuvant or neoadjuvant chemotherapy allowed
* At least 4 weeks since prior chemotherapy and recovered
* No more than 2 prior regimens of cytotoxic chemotherapy for metastatic disease
* No prior oxaliplatin
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy except hormone replacement therapy
Radiotherapy:
* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to target lesion unless the lesion has shown progression after completion of radiotherapy
* No concurrent therapeutic radiotherapy
* Focal radiotherapy for palliation of bone symptoms may be allowed
Surgery:
* At least 1 week since prior minor surgery (3 weeks for major surgery) and recovered
Other:
* No other concurrent experimental anticancer medicationsReferences
Publications (0)
Data not yet available
No reference posted for this study.