A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-metastatic Pancreatic Adenocarcinoma
18 Years
75 Years
Both
Pancreatic Cancer
Trial Information
A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-metastatic Pancreatic Adenocarcinoma
This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU,
and external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic
cancer.
All patients will be assessed by history and physical examination including weight, vital
signs, and performance status within 14 days of initiation of therapy. Baseline hematologic
and biochemical profiles, including CBC with differential, alkaline phosphatase, bilirubin,
SGOT (AST), BUN, creatinine, and CA 19-9 will be completed within 14 days of initiation of
therapy.
During cycle I (chemoradiation), gemcitabine (200 mg/m2) and cetuximab 400mg/m2 initial dose
followed by 250mg/m2 IV weekly will be given with continuous infusion 5-FU (200 mg/m2/day)
delivered 5 of every 7 days and concurrent external beam radiation therapy. Cetuximab,
gemcitabine and 5-FU will begin on the first week of external beam radiotherapy and will
continue throughout the course of external beam radiation therapy, and will be discontinued
following the conclusion of external beam radiation therapy. All patients will have a
central venous access device placed to facilitate chemotherapy administration.
During cycles 2 through 5 (chemotherapy), gemcitabine will be administered at a dose of 1000
mg/m2 over 30 minutes followed by cetuximab at a dose of 250mg/m2 over 30 minutes weekly for
3 weeks followed by one-week rest for four cycles.
Inclusion Criteria:
- Histological confirmation of pancreatic adenocarcinoma is required.
- Only patients with unresectable, non-metastatic tumors are eligible.
- Documentation of disease extent by endoscopic ultrasound and either laparotomy or
laparoscopy must be performed within 42 days of registration.
- All patients will also be assessed by chest x-ray and abdominal-pelvic CT scan.
- Confirmation of palliative surgical bypass at the time of laparotomy or whether a
biliary stent was placed will be requested.
- Disease must be locoregional and not amenable to surgery based on one or more of the
following criteria:
- size of pancreatic tumor > 5 cm.
- lymph nodes (bulky, > 2 cm, but within a radiation port)
- vascular involvement or impingement of major vessels (superior mesenteric
artery, superior mesenteric vein, portal vein, hepatic artery).
- invasion into the adjacent structures.
- Patients with either measurable or evaluable disease are eligible.
- Patients with evidence of peritoneal seeding by malignancy are not eligible for the
study.
- Patients with other evidence of metastatic disease are not eligible.
- Patients with concurrent malignancy of any site, except limited basal cell carcinoma
or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, are
ineligible.
- Patients with any other malignancy within 5 years of study entry, except curatively
treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in
situ of the cervix, are ineligible.
- Patients may not have had prior therapy for carcinoma of the pancreas, nor prior
abdominal radiation therapy.
- Age > 18 years.
- CTC performance status < 2.
- No myocardial infarction in the past six months.
- No major surgery in the past two weeks.
- No uncontrolled serious medical or psychiatric illness.
- Required Initial Laboratory Data:
- Total bilirubin < 2.0 mg/dl
- AST < 3x upper limits of normal.
- Serum creatinine < 2.0 mg/dl
- WBC > 3,000/mm3 (ANC>1500/mm3)
- Platelets > 100,000 mm3
- CA 19-9
- Required Diagnostic procedures:
- Chest X-ray
- Abdominal pelvic CT scan
- EUS
- Staging laparoscopy or staging laparotomy
Exclusion Criteria:
Enrollment in this trial will be limited to patients for whom protocol therapy is safe and
appropriate. Physicians should consider the risks and benefits of therapy together with
all relevant medical and other considerations in deciding whether this protocol is
appropriate for a particular patient. Specific considerations include:
- Psychiatric illness which would prevent the patient from giving informed consent.
- Serious medical illness such as uncontrolled infection, severe cardiovascular disease
including recent (< 6 months) myocardial infarction or uncontrolled congestive heart
failure, or other serious illness which would limit anticipated survival to < 12
weeks.
- Protocol treatment would pose significant risk to an unborn child. Pregnant women
should not be enrolled, and women of child-bearing age should be strongly encouraged
to practice effective birth control during and for three months after the trial.
- Inability to swallow medication. Patients should have adequate, unassisted oral
intake.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess progression-free survival of patients with locally advanced pancreatic cancer who are treated with concurrent gemcitabine, 5-FU, cetuximab and external beam radiation therapy.
Outcome Time Frame:
1-year
Safety Issue:
No
Principal Investigator
Venu Bathini, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Massachusetts, Worcester
Authority:
United States: Institutional Review Board
Study ID:
UM200602
NCT ID:
NCT00424827
Start Date:
June 2006
Completion Date:
December 2013
Related Keywords:
- Pancreatic Cancer
- pancreatic cancer, gemcitabine, 5-FU, cetuximab, radiation
- Pancreatic Neoplasms
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