Clinical trial · Interventional
A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer
A Phase II, Open Label Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer
NCT00383149CI-TRIAL-00021281completedPhase 2Results postedClinicalTrials.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)
The purpose of this clinical research study is to learn if ixabepilone plus cetuximab improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic cancer compared to historical data. The safety of this combination treatment will also be studied.
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 |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ixabepilone plus Cetuximab
- description
- All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
- interventionNames
- Drug: Ixabepilone
- Drug: Cetuximab
Primary outcomes (1)
- measure
- Percentage of Participants Surviving at 6 Months
- timeFrame
- From time of first dose of study drug through 6 months
- description
- The percentage of participants surviving at 6 months was defined as the number of treated participants who had not died prior to 6 months from the date of their first dose divided by the total number of treated participants.
Secondary outcomes (12)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis of pancreatic adenocarcinoma (locally advanced disease that is not surgically resectable, or distant metastatic disease) * Participants must have measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines * Participants must not have received prior chemotherapy, immunotherapy or chemoradiotherapy for advanced pancreas cancer * Karnofsky performance status (KPS) of 70-100 * Adequate hematologic, hepatic and renal function
References
Publications (0)
Data not yet available
No reference posted for this study.