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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000582420 | Registry Identifier | PDQ (Physician Data Query) | |
| EUDRACT-2006-001742-13 | |||
| EU-207103 | |||
| CTA-21266/0210/001-0001 |
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RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving cetuximab together with 3-dimensional conformal radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetuximab | Biological | |||
| 3-dimensional conformal radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival rate at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate by RECIST criteria | ||
| Toxicity by NCI CTCAE criteria | ||
| Clinical benefit response |
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DISEASE CHARACTERISTICS:
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:
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:
No previous radiotherapy within current treatment field
No previous administration of EGF monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted therapy
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| Name | Affiliation | Role |
|---|---|---|
| Pat Price, MD | The Christie NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cookridge Hospital | Leeds | England | LS16 6QB | United Kingdom | ||
| Christie Hospital |
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| Manchester |
| England |
| M20 4BX |
| United Kingdom |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D020266 | Radiotherapy, Conformal |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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