Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00599833
• Date of registration: 11/01/2008
• Primary sponsor: Christie Hospital NHS Foundation Trust
• Public title: Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
• Scientific title: Locally Advanced Pancreatic Cancer: Phase II Study of Cetuximab and 3-D Conformal Image Guided Radiotherapy (PACER)
• Date of first enrolment: May 2007
• Target sample size: 44
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00599833
• Study type: Interventional
• Study design: Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United Kingdom

Contacts

• Name: Pat Price, MD
• Affiliation: Christie Hospital NHS Foundation Trust

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pancreatic Cancer

Intervention(s)

Biological: cetuximab

Radiation: 3-dimensional conformal radiation therapy

Primary Outcome(s)

Progression-free survival rate at 6 months [Time Frame: No]

Secondary Outcome(s)

Clinical benefit response [Time Frame: No]

Response rate by RECIST criteria [Time Frame: No]

Toxicity by NCI CTCAE criteria [Time Frame: Yes]

Secondary ID(s)

CDR0000582420

CHNT-PACER

CTA-21266/0210/001-0001

EU-207103

EUDRACT-2006-001742-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors