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Locally Advanced Pancreatic Cancer: Phase II Study of Cetuximab and 3-D Conformal Image Guided Radiotherapy (PACER)


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

Thank you

Trial Information

Locally Advanced Pancreatic Cancer: Phase II Study of Cetuximab and 3-D Conformal Image Guided Radiotherapy (PACER)


OBJECTIVES:

Primary

- To evaluate the progression free survival rate in patients treated with cetuximab and
radiotherapy.

Secondary

- To determine the response rate, toxicity of the combined regimen, and clinical benefit
response in patients treated with cetuximab and radiotherapy.

OUTLINE: Patients receive cetuximab IV over 1-2 hours once weekly for 6-7 weeks. Patients
also undergo concurrent 3-dimensional image-guided conformal radiotherapy in 28-30 fractions
over approximately 5.5-6 weeks (2-4 hours after administration of cetuximab).

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for up to 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histopathologically or cytologically confirmed diagnosis of inoperable,
non-metastatic, locally advanced pancreatic adenocarcinoma

- No neuroendocrine tumors or lymphoma of the pancreas

- No extensive disease unable to be covered in a radically treatable radiotherapy
volume

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

- Life expectancy > 3 months

- Hemoglobin ≥ 10g/dL

- WBC ≥ 3,000/mm³

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³ (prior transfusions for patients with low hemoglobin
allowed)

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT and AST ≤ 1.5 times ULN

- Alkaline phosphatase ≤ 1.5 times ULN

- Serum urea ≤ 1.5 times ULN

- Creatinine ≤ 1.5 times ULN

- Adequate biliary drainage with no evidence of active uncontrolled infection (patients
on prophylactic antibiotics are eligible)

- Not pregnant or nursing

- Negative pregnancy test

- Women and men of child-bearing potential should be using an adequate contraception
method, which must be continued for 3 months after completion of therapy

- No unresolved biliary tract obstruction

- No history of prior malignancy that may interfere with the response evaluation except
for any of the following:

- Cervical carcinoma in-situ treated by cone-biopsy/resection

- Nonmetastatic basal and/or squamous cell carcinomas of the skin

- Any early stage (stage I) malignancy adequately resected for cure greater than 5
years previously

- No relative contraindication to radiotherapy

- No evidence of severe uncontrolled systemic diseases or laboratory finding that in
the view of investigator makes it undesirable for the patient to participate in the
trial

- No disorder likely to impact compliance with the protocol

PRIOR CONCURRENT THERAPY:

- Must be completely recovered from previous surgery

- The following prior interventions are allowed:

- Non-curative operation (i.e., R2 resection with macroscopic residual disease
evident on CT scan or palliative bypass procedure)

- Stent insertion in the common bile duct

- No previous radiotherapy within current treatment field

- No previous administration of EGF monoclonal antibodies, EGFR signal transduction
inhibitors or EGFR-targeted therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate at 6 months

Safety Issue:

No

Principal Investigator

Pat Price, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Christie Hospital NHS Foundation Trust

Authority:

United States: Federal Government

Study ID:

CHNT-PACER

NCT ID:

NCT00599833

Start Date:

May 2007

Completion Date:

October 2010

Related Keywords:

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

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