A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Pancreatic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ixabepilone plus Cetuximab

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).

Group Type EXPERIMENTAL

Ixabepilone

Intervention Type DRUG

Intravenous Infusion (IV), 32 mg/m\^2 every 21 days.

Cetuximab

Intervention Type DRUG

Initial dose of 400 mg/m\^2 intravenous (IV) over 2 hours) followed by a weekly lower dose of 250 mg/m\^2 IV over 1 hour.

Interventions

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Ixabepilone

Intravenous Infusion (IV), 32 mg/m\^2 every 21 days.

Intervention Type DRUG

Cetuximab

Initial dose of 400 mg/m\^2 intravenous (IV) over 2 hours) followed by a weekly lower dose of 250 mg/m\^2 IV over 1 hour.

Intervention Type DRUG

Other Intervention Names

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IXEMPRA® Erbitux® BMS-247550 BMS-564717

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No