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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Pancreatic Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants Surviving at 6 Months

Outcome Description:

The percentage of participants surviving at 6 months was defined as the number of treated participants who had not died prior to 6 months from the date of their first dose divided by the total number of treated participants.

Outcome Time Frame:

From time of first dose of study drug through 6 months

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA163-116

NCT ID:

NCT00383149

Start Date:

January 2007

Completion Date:

June 2009

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Mayo Clinic JacksonvilleJacksonville, Florida  32224
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Ellis Fischel Cancer CenterColumbia, Missouri  65203
Seattle Cancer Care AllianceSeattle, Washington  98109
Wayne State UniversityDetroit, Michigan  48202
University of MiamiMiami, Florida  33136
West Virginia UniversityMorgantown, West Virginia  26506
Georgetn Univ Lombardi Can CtrWashington, District of Columbia  20007