Cetuximab Plus Gemcitabine in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Pancreas

December 11, 2013 updated by: University of Alabama at Birmingham

Phase II Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody C225 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer

RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cell from dividing so they stop growing or die. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cetuximab plus gemcitabine in treating patients who have locally advanced, metastatic, or recurrent cancer of the pancreas.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine objective response, time to progression, survival, clinical benefit response, and quality of life of patients with locally advanced, metastatic, or recurrent adenocarcinoma of the pancreas when treated with cetuximab and gemcitabine. II. Determine the safety and toxicity profile of this regimen in this patient population.

OUTLINE: This is a multicenter study. Patients receive a test dose of cetuximab IV over 10 minutes followed by a 30 minute observation period. Following observation, patients receive a loading dose of cetuximab IV over 1-2 hours followed 1 hour later by gemcitabine IV over 30 minutes weekly for 7 weeks. Following 1 week of rest, patients with stable or responding disease continue treatment for a maximum of 6 months. During subsequent courses, patients receive maintenance doses of cetuximab IV over 1 hour weekly for 8 weeks. Gemcitabine IV is administered over 30 minutes weekly for 3 weeks, followed by 1 week of rest, and then repeated for a total treatment course of 8 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline, after each course of therapy, and at 3 months after therapy. Patients are followed every 3 months until evidence of disease progression.

PROJECTED ACCRUAL: A minimum of 40 patients will be accrued for this study within 8 months.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed locally advanced, metastatic, or recurrent adenocarcinoma of the pancreas that is not amenable to curative surgical resection Immunohistochemical evidence of EGFr expression of 1+ or greater Measurable disease No history of treated or active brain metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 No unstable coagulation disorders Hepatic: AST/ALT no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Bilirubin no greater than 2 times ULN Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No uncontrolled hypertension or arrhythmias No unstable congestive heart failure Neurologic: No uncontrolled seizure disorder No active neurological disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent unstable medical condition (e.g., uncontrolled diabetes mellitus or active infections requiring systemic antibiotics, antivirals, or antifungals)

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy No prior cetuximab Chemotherapy: No prior chemotherapy for advanced pancreatic cancer Prior adjuvant chemotherapy following complete surgical resection allowed provided cancer recurrence was first documented more than 6 months after completion of treatment Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to only site of measurable disease unless documented disease progression since prior irradiation Surgery: Prior surgical resection allowed Other: At least 4 weeks since other prior investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Albert F. LoBuglio, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Primary Completion (Actual)

April 1, 2003

Study Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

August 6, 2004

First Posted (Estimate)

August 9, 2004

Study Record Updates

Last Update Posted (Estimate)

December 13, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067696
  • UAB-9929
  • IMCL-CP02-9814
  • UAB-F990927003
  • NCI-G00-1729

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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