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

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

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

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Albert F. LoBuglio, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms