Pancreatic Cancer Research

Clinical trialPhase 2Completed

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

NCT00383149 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Outcome unknown
Phase: Phase 2
Status: Completed
Study type: Interventional
Start: January 2007
Expected end: June 2009
Enrollment: 58 participants
Sites: 9
Primary outcomes: Percentage of Participants Surviving at 6 Months
Sponsor: Industry
Results posted: 2010-10-19
Last update: 10 March 2016

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Brief summary public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Percentage of Participants Surviving at 6 Months [From time of first dose of study drug through 6 months]. Number, percentage of participants (95% Confidence Interval). Ixabepilone + Cetuximab (n=54): 57.4 (43.2 to 70.8).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Best Overall Tumor Response [From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression)]. Number, participants. Participants with Complete Response: Ixabepilone + Cetuximab (n=31): 0. Participants with Partial Response: Ixabepilone + Cetuximab (n=31): 4. Participants with Stable Disease: Ixabepilone + Cetuximab (n=31): 24. Participants with Progressive Disease: Ixabepilone + Cetuximab (n=31): 2. Participants with Response Unable to be Determined: Ixabepilone + Cetuximab (n=31): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percentage of Participants With Objective Tumor Response [From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression]. Number, percentage of participants (95% Confidence Interval). Ixabepilone + Cetuximab (n=31): 12.9 (3.6 to 29.8).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Median Progression Free Survival Time [From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression]. Median, months (95% Confidence Interval). Ixabepilone + Cetuximab (n=54): 3.9 (2.6 to 4.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Median Overall Survival Time [From the first dosing date until death (last reported death was 21 months after first dose).]. Median, months (95% Confidence Interval). Ixabepilone + Cetuximab (n=54): 7.6 (5.5 to 12.2).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Median Duration of Response [From first date recorded for CR or PR until the first date of disease progression or death (last participant with tumor response progressed 6.5 months after documented response).]. Median, months (95% Confidence Interval). Ixabepilone + Cetuximab (n=4): 5.7 (2.8 to 6.3).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Median Time to Response [Time from first dose of study therapy until first date of PR or CR. Maximum time to response was 19 months.]. Median, weeks (Full Range). Ixabepilone + Cetuximab (n=4): 8.8 (5.1 to 19.0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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) [From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.]. Number, participants. All deaths within 30 days of last dose: Ixabepilone + Cetuximab (n=54): 7. Any SAE: Ixabepilone + Cetuximab (n=54): 32. Gr 2 (moderate) AE leading to DC: Ixabepilone + Cetuximab (n=54): 2. Gr 3 (severe) AE leading to DC: Ixabepilone + Cetuximab (n=54): 9. Gr 4 (life-threatening) AE leading to DC: Ixabepilone + Cetuximab (n=54): 3. All AEs leading to DC: Ixabepilone + Cetuximab (n=54): 14. Gr 1 (mild) treatment-related AE: Ixabepilone + Cetuximab (n=54): 4. Gr 2 (moderate) treatment-related AE: Ixabepilone + Cetuximab (n=54): 13. Gr 3 (severe) treatment-related AE: Ixabepilone + Cetuximab (n=54): 25. Gr 4 (life-threatening) treatment-related AE: Ixabepilone + Cetuximab (n=54): 10. Gr 5 (death) treatment-related AE: Ixabepilone + Cetuximab (n=54): 1. All treatment-related AEs: Ixabepilone + Cetuximab (n=54): 53.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr) [From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.]. Number, participants. Gr 1 (mild) acneform rash: Ixabepilone + Cetuximab (n=54): 21. Gr 2 (moderate) acneform rash: Ixabepilone + Cetuximab (n=54): 13. Gr 3 (severe) acneform rash: Ixabepilone + Cetuximab (n=54): 1. All acneform rash: Ixabepilone + Cetuximab (n=54): 35. Gr 1 (mild) fatigue: Ixabepilone + Cetuximab (n=54): 8. Gr 2 (moderate) fatigue: Ixabepilone + Cetuximab (n=54): 13. Gr 3 (severe) fatigue: Ixabepilone + Cetuximab (n=54): 8. Gr 4 (life-threatening) fatigue: Ixabepilone + Cetuximab (n=54): 1. All fatigue: Ixabepilone + Cetuximab (n=54): 30. Gr 1 (mild) alopecia: Ixabepilone + Cetuximab (n=54): 13. Gr 2 (moderate) alopecia: Ixabepilone + Cetuximab (n=54): 12. All alopecia: Ixabepilone + Cetuximab (n=54): 25. Gr 1 (mild) nausea: Ixabepilone + Cetuximab (n=54): 13. Gr 2 (moderate) nausea: Ixabepilone + Cetuximab (n=54): 6. Gr 3 (severe) nausea: Ixabepilone + Cetuximab (n=54): 3. All nausea: Ixabepilone + Cetuximab (n=54): 22. Gr 1 (mild) diarrhea: Ixabepilone + Cetuximab (n=54): 11. Gr 2 (moderate) diarrhea: Ixabepilone + Cetuximab (n=54): 4. Gr 3 (severe) diarrhea: Ixabepilone + Cetuximab (n=54): 1. Gr 4 (life-threatening) diarrhea: Ixabepilone + Cetuximab (n=54): 2. All diarrhea: Ixabepilone + Cetuximab (n=54): 18. Gr 1 (mild) vomiting: Ixabepilone + Cetuximab (n=54): 12. Gr 2 (moderate) vomiting: Ixabepilone + Cetuximab (n=54): 2. Gr 3 (severe) vomiting: Ixabepilone + Cetuximab (n=54): 3. All vomiting: Ixabepilone + Cetuximab (n=54): 17. Gr 1 (mild) peripheral neuropathy: Ixabepilone + Cetuximab (n=54): 12. Gr 2 (moderate) peripheral neuropathy: Ixabepilone + Cetuximab (n=54): 1. Gr 3 (severe) peripheral neuropathy: Ixabepilone + Cetuximab (n=54): 3. All peripheral neuropathy: Ixabepilone + Cetuximab (n=54): 16. Gr 1 (mild) hypomagnesemia: Ixabepilone + Cetuximab (n=54): 7. Gr 2 (moderate) hypomagnesemia: Ixabepilone + Cetuximab (n=54): 4. Gr 3 (severe) hypomagnesemia: Ixabepilone + Cetuximab (n=54): 1. Gr 4 (life-threatening) hypomagnesemia: Ixabepilone + Cetuximab (n=54): 3. All hypomagnesemia: Ixabepilone + Cetuximab (n=54): 15.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr) [From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.]. Number, participants. Gr 0 (no abnormality) WBC, n=51: Ixabepilone + Cetuximab (n=54): 12. Gr 1 (mild) WBC, n=51: Ixabepilone + Cetuximab (n=54): 9. Gr 2 (moderate) WBC, n=51: Ixabepilone + Cetuximab (n=54): 9. Gr 3 (severe) WBC, n=51: Ixabepilone + Cetuximab (n=54): 17. Gr 4 (life-threatening) WBC, n=51: Ixabepilone + Cetuximab (n=54): 4. Gr 1-4 WBC, n=51: Ixabepilone + Cetuximab (n=54): 39. Gr 3-4 WBC, n=51: Ixabepilone + Cetuximab (n=54): 21. Gr 0 (no abnormality) ANC, n=50: Ixabepilone + Cetuximab (n=54): 12. Gr 1 (mild) ANC, n=50: Ixabepilone + Cetuximab (n=54): 8. Gr 2 (moderate) ANC, n=50: Ixabepilone + Cetuximab (n=54): 12. Gr 3 (severe) ANC, n=50: Ixabepilone + Cetuximab (n=54): 10. Gr 4 (life-threatening) ANC, n=50: Ixabepilone + Cetuximab (n=54): 8. Gr 1-4 ANC, n=50: Ixabepilone + Cetuximab (n=54): 38. Gr 3-4 ANC, n=51: Ixabepilone + Cetuximab (n=54): 18. Gr 0 (no abnormality) platelet count, n=51: Ixabepilone + Cetuximab (n=54): 29. Gr 1 (mild) platelet count, n=51: Ixabepilone + Cetuximab (n=54): 18. Gr 2 (moderate) platelet count, n=51: Ixabepilone + Cetuximab (n=54): 4. Gr 1-4 platelet count, n=51: Ixabepilone + Cetuximab (n=54): 2. Gr 0 (no abnormality) HGB, n=51: Ixabepilone + Cetuximab (n=54): 3. Gr 1 (mild) HGB, n=51: Ixabepilone + Cetuximab (n=54): 28. Gr 2 (moderate) HGB, n=51: Ixabepilone + Cetuximab (n=54): 18. Gr 3 (severe) HGB, n=51: Ixabepilone + Cetuximab (n=54): 2. Gr 1-4 HGB, n=51: Ixabepilone + Cetuximab (n=54): 48. Gr 3-4 HGB, n=51: Ixabepilone + Cetuximab (n=54): 2. Gr 0 (no abnormality) ALT, n=46: Ixabepilone + Cetuximab (n=54): 31. Gr 1 (mild) ALT, n=46: Ixabepilone + Cetuximab (n=54): 10. Gr 2 (moderate) ALT, n=46: Ixabepilone + Cetuximab (n=54): 3. Gr 3 (severe) ALT, n=46: Ixabepilone + Cetuximab (n=54): 2. Gr 1-4 ALT, n=46: Ixabepilone + Cetuximab (n=54): 15. Gr 3-4 ALT, n=46: Ixabepilone + Cetuximab (n=54): 2. Gr 0 (no abnormality) AST, n=47: Ixabepilone + Cetuximab (n=54): 28. Gr 1 (mild) AST, n=47: Ixabepilone + Cetuximab (n=54): 17. Gr 3 (severe) AST, n=47: Ixabepilone + Cetuximab (n=54): 2. Gr 1-4 AST, n=47: Ixabepilone + Cetuximab (n=54): 19. Gr 3-4 AST, n=47: Ixabepilone + Cetuximab (n=54): 2. Gr 0 (no abnormality) alkaline phosphatase, n=47: Ixabepilone + Cetuximab (n=54): 18. Gr 1 (mild) alkaline phosphatase, n=47: Ixabepilone + Cetuximab (n=54): 20. Gr 2 (moderate) alkaline phosphatase, n=47: Ixabepilone + Cetuximab (n=54): 5. Gr 3 (severe) alkaline phosphatase, n=47: Ixabepilone + Cetuximab (n=54): 4. Gr 1-4 alkaline phosphatase, n=47: Ixabepilone + Cetuximab (n=54): 29. Gr 3-4 alkaline phosphatase, n=47: Ixabepilone + Cetuximab (n=54): 4. Gr 0 (no abnormality) total bilirubin, n=48: Ixabepilone + Cetuximab (n=54): 42. Gr 1 (mild) total b

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Dose Reduction, Dose Delay, or Dose Interruption [From the first dosing date of Cycle 1 until the last dosing date of the last cycle. Last dosing cycle for a participant was Cycle 21.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percentage of Participants With Baseline Epidermal Growth Factor Receptor (EGFR) Tumor Expression [Baseline].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in FHSI-8 Total Score by Time-point [Baseline, Week 3, Week 6, Week 9, Week 12, Week 12, Week 18, Week 24 and every 3 weeks through end of study (participant death/withdrawal from study)].