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

R-Pharm

Status and phase: Completed; Phase 2

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: Cetuximab; Drug: Ixabepilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00383149

CA163-116

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Ixabepilone plus Cetuximab

Experimental group

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).

Treatment:

Drug: Cetuximab

Drug: Ixabepilone