Phase 2
Completed N=54
A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer
Source: ClinicalTrials.gov NCT00383149 ↗Enrolled (actual)
54
Serious AEs
59.3%
Results posted
Oct 2010
Primary outcomePrimary: Percentage of Participants Surviving at 6 Months — 57.4 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Surviving at 6 Months |
57.4 | — |
| SECONDARY Best Overall Tumor Response |
0; 4; 24; 2; 1 | — |
| SECONDARY Percentage of Participants With Objective Tumor Response |
12.9 | — |
| SECONDARY Median Progression Free Survival Time |
3.9 | — |
| SECONDARY Median Overall Survival Time |
7.6 | — |
| SECONDARY Median Duration of Response |
5.7 | — |
| SECONDARY Median Time to Response |
8.8 | — |
| SECONDARY Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr) |
7; 32; 2; 9; 3; 14 | — |
| SECONDARY Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr) |
21; 13; 1; 35; 8; 13 | — |
| SECONDARY Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr) |
12; 9; 9; 17; 4; 39 | — |
| SECONDARY Number of Participants With Dose Reduction, Dose Delay, or Dose Interruption |
— | — |
| SECONDARY Percentage of Participants With Baseline Epidermal Growth Factor Receptor (EGFR) Tumor Expression |
— | — |
| SECONDARY Change From Baseline in FHSI-8 Total Score by Time-point |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00383149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.