A phase 2 trial of ixabepilone plus cetuximab in first-line treatment of metastatic pancreatic cancer

Caio M. Rocha Lima; Edward H. Lin; George P. Kim; Jeffrey K. Giguere; John Marshall; Mark Zalupski; Chris Papageorgio; Miklos L. Auber; Remigiusz Kaleta; M. Brent Mchenry; Ovidiu C. Trifan; Philip A. Philip

A phase 2 trial of ixabepilone plus cetuximab in first-line treatment of metastatic pancreatic cancer

Caio M. Rocha Lima, Edward H. Lin, George P. Kim, Jeffrey K. Giguere, John Marshall, Mark Zalupski, Chris Papageorgio, Miklos L. Auber, Remigiusz Kaleta, M. Brent Mchenry, Ovidiu C. Trifan, Philip A. Philip

Medicine

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Abstract

BACKGROUND: The aim of this phase 2 study was to evaluate the safety and efficacy of ixabepilone plus cetuximab in patients with advanced pancreatic cancer. METHODS: Eligible patients had advanced pancreatic adenocarcinoma that was metastatic or not amenable to resection, a Karnofsky performance status ≥70%, and no prior therapy for advanced disease. Patients received ixabepilone 32 mg/m² (3-hour IV infusion) every 3 weeks and cetuximab 250 mg/m² (1-hour IV infusion) weekly. The primary efficacy end point was the 6-month survival rate. Secondary end points included tumor response rate, overall survival, progression- free survival, and tolerability. RESULTS: A total of 54 patients were enrolled on this study. The 6-month survival rate was 57% (31/54:95% CI: 43-71%) with a median overall survival of 7.6 months (95% CI: 5.5-12.2 months). Patients who developed acneiform rash (n = 36) had a median survival of 8.8 months, compared with 2.6 months for those without rash (n = 18). Of 31 patients with measurable disease (defined as response-evaluable), 4 had confirmed partial responses and an additional 24 had stable disease. The combination was generally well-tolerated with the most common grade 3/4 hematological toxicities being leucopenia (39%) and neutropenia (33%). The most common grade 3/4 nonhematologic toxicity was fatigue (17%). CONCLUSIONS: The combination of ixabepilone and cetuximab was active and had acceptable toxicity. The efficacy results are similar to single-agent ixabepilone and gemcitabine-based combination therapies in patients with advanced pancreatic cancer. Exploratory analyses suggest a trend toward improved survival for patients who experienced rash. Gastrointest Cancer Res 5:155-160.

Original language	English (US)
Pages (from-to)	155-160
Number of pages	6
Journal	Gastrointestinal Cancer Research
Volume	5
Issue number	5
State	Published - Sep 1 2012

ASJC Scopus subject areas

Oncology
Gastroenterology

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Rocha Lima, C. M., Lin, E. H., Kim, G. P., Giguere, J. K., Marshall, J., Zalupski, M., Papageorgio, C., Auber, M. L., Kaleta, R., Mchenry, M. B., Trifan, O. C., & Philip, P. A. (2012). A phase 2 trial of ixabepilone plus cetuximab in first-line treatment of metastatic pancreatic cancer. Gastrointestinal Cancer Research, 5(5), 155-160.

A phase 2 trial of ixabepilone plus cetuximab in first-line treatment of metastatic pancreatic cancer. / Rocha Lima, Caio M.; Lin, Edward H.; Kim, George P.; Giguere, Jeffrey K.; Marshall, John; Zalupski, Mark; Papageorgio, Chris; Auber, Miklos L.; Kaleta, Remigiusz; Mchenry, M. Brent; Trifan, Ovidiu C.; Philip, Philip A.

In: Gastrointestinal Cancer Research, Vol. 5, No. 5, 01.09.2012, p. 155-160.

Research output: Contribution to journal › Article

Rocha Lima, Caio M. ; Lin, Edward H. ; Kim, George P. ; Giguere, Jeffrey K. ; Marshall, John ; Zalupski, Mark ; Papageorgio, Chris ; Auber, Miklos L. ; Kaleta, Remigiusz ; Mchenry, M. Brent ; Trifan, Ovidiu C. ; Philip, Philip A. / A phase 2 trial of ixabepilone plus cetuximab in first-line treatment of metastatic pancreatic cancer. In: Gastrointestinal Cancer Research. 2012 ; Vol. 5, No. 5. pp. 155-160.

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title = "A phase 2 trial of ixabepilone plus cetuximab in first-line treatment of metastatic pancreatic cancer",

abstract = "BACKGROUND: The aim of this phase 2 study was to evaluate the safety and efficacy of ixabepilone plus cetuximab in patients with advanced pancreatic cancer. METHODS: Eligible patients had advanced pancreatic adenocarcinoma that was metastatic or not amenable to resection, a Karnofsky performance status ≥70%, and no prior therapy for advanced disease. Patients received ixabepilone 32 mg/m2 (3-hour IV infusion) every 3 weeks and cetuximab 250 mg/m2 (1-hour IV infusion) weekly. The primary efficacy end point was the 6-month survival rate. Secondary end points included tumor response rate, overall survival, progression- free survival, and tolerability. RESULTS: A total of 54 patients were enrolled on this study. The 6-month survival rate was 57% (31/54:95% CI: 43-71%) with a median overall survival of 7.6 months (95% CI: 5.5-12.2 months). Patients who developed acneiform rash (n = 36) had a median survival of 8.8 months, compared with 2.6 months for those without rash (n = 18). Of 31 patients with measurable disease (defined as response-evaluable), 4 had confirmed partial responses and an additional 24 had stable disease. The combination was generally well-tolerated with the most common grade 3/4 hematological toxicities being leucopenia (39%) and neutropenia (33%). The most common grade 3/4 nonhematologic toxicity was fatigue (17%). CONCLUSIONS: The combination of ixabepilone and cetuximab was active and had acceptable toxicity. The efficacy results are similar to single-agent ixabepilone and gemcitabine-based combination therapies in patients with advanced pancreatic cancer. Exploratory analyses suggest a trend toward improved survival for patients who experienced rash. Gastrointest Cancer Res 5:155-160.",

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T1 - A phase 2 trial of ixabepilone plus cetuximab in first-line treatment of metastatic pancreatic cancer

AU - Rocha Lima, Caio M.

AU - Lin, Edward H.

AU - Kim, George P.

AU - Giguere, Jeffrey K.

AU - Marshall, John

AU - Zalupski, Mark

AU - Papageorgio, Chris

AU - Auber, Miklos L.

AU - Kaleta, Remigiusz

AU - Mchenry, M. Brent

AU - Trifan, Ovidiu C.

AU - Philip, Philip A.

PY - 2012/9/1

Y1 - 2012/9/1

N2 - BACKGROUND: The aim of this phase 2 study was to evaluate the safety and efficacy of ixabepilone plus cetuximab in patients with advanced pancreatic cancer. METHODS: Eligible patients had advanced pancreatic adenocarcinoma that was metastatic or not amenable to resection, a Karnofsky performance status ≥70%, and no prior therapy for advanced disease. Patients received ixabepilone 32 mg/m2 (3-hour IV infusion) every 3 weeks and cetuximab 250 mg/m2 (1-hour IV infusion) weekly. The primary efficacy end point was the 6-month survival rate. Secondary end points included tumor response rate, overall survival, progression- free survival, and tolerability. RESULTS: A total of 54 patients were enrolled on this study. The 6-month survival rate was 57% (31/54:95% CI: 43-71%) with a median overall survival of 7.6 months (95% CI: 5.5-12.2 months). Patients who developed acneiform rash (n = 36) had a median survival of 8.8 months, compared with 2.6 months for those without rash (n = 18). Of 31 patients with measurable disease (defined as response-evaluable), 4 had confirmed partial responses and an additional 24 had stable disease. The combination was generally well-tolerated with the most common grade 3/4 hematological toxicities being leucopenia (39%) and neutropenia (33%). The most common grade 3/4 nonhematologic toxicity was fatigue (17%). CONCLUSIONS: The combination of ixabepilone and cetuximab was active and had acceptable toxicity. The efficacy results are similar to single-agent ixabepilone and gemcitabine-based combination therapies in patients with advanced pancreatic cancer. Exploratory analyses suggest a trend toward improved survival for patients who experienced rash. Gastrointest Cancer Res 5:155-160.

AB - BACKGROUND: The aim of this phase 2 study was to evaluate the safety and efficacy of ixabepilone plus cetuximab in patients with advanced pancreatic cancer. METHODS: Eligible patients had advanced pancreatic adenocarcinoma that was metastatic or not amenable to resection, a Karnofsky performance status ≥70%, and no prior therapy for advanced disease. Patients received ixabepilone 32 mg/m2 (3-hour IV infusion) every 3 weeks and cetuximab 250 mg/m2 (1-hour IV infusion) weekly. The primary efficacy end point was the 6-month survival rate. Secondary end points included tumor response rate, overall survival, progression- free survival, and tolerability. RESULTS: A total of 54 patients were enrolled on this study. The 6-month survival rate was 57% (31/54:95% CI: 43-71%) with a median overall survival of 7.6 months (95% CI: 5.5-12.2 months). Patients who developed acneiform rash (n = 36) had a median survival of 8.8 months, compared with 2.6 months for those without rash (n = 18). Of 31 patients with measurable disease (defined as response-evaluable), 4 had confirmed partial responses and an additional 24 had stable disease. The combination was generally well-tolerated with the most common grade 3/4 hematological toxicities being leucopenia (39%) and neutropenia (33%). The most common grade 3/4 nonhematologic toxicity was fatigue (17%). CONCLUSIONS: The combination of ixabepilone and cetuximab was active and had acceptable toxicity. The efficacy results are similar to single-agent ixabepilone and gemcitabine-based combination therapies in patients with advanced pancreatic cancer. Exploratory analyses suggest a trend toward improved survival for patients who experienced rash. Gastrointest Cancer Res 5:155-160.

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