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A Phase II Pilot Study of Multi-Agent Neo-Adjuvant Chemoradiation in Patients With Locally Advanced Pancreatic Adenocarcinoma

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Phase II Pilot Study of Multi-Agent Neo-Adjuvant Chemoradiation in Patients With Locally Advanced Pancreatic Adenocarcinoma



- Determine the effect of neoadjuvant chemoradiotherapy and interferon alfa on converting
patients with locally advanced unresectable adenocarcinoma of the pancreas to


- Determine the rate and severity of early and late toxic effects of these regimens in
these patients.

- Improve surgical morbidity profile and overall survival of patients who undergo
surgical resection.

- Determine overall and progression-free survival of patients treated with this regimen.

OUTLINE: This is an pilot, single center study.

- Part 1 (neoadjuvant therapy): Patients receive fluorouracil IV continuously over 24
hours on days 1-38; cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36; and
interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29,
31, 33, 36, and 38. Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26,
29-33, and 36-38. Patients then undergo restaging. Patients with resectable disease
undergo surgery, and 4-10 weeks later, proceed to part 2. Patients with unresectable
disease proceed directly to part 2, 4 weeks after completion of neoadjuvant therapy.

- Part 2 (chemotherapy): Patients receive fluorouracil IV on days 1, 8, 15, 22, 29, and
36. Treatment repeats every 56 days for up to 2 courses in the absence of disease
progression or unacceptable toxicity. Patients with unresectable disease undergo
restaging after each course of fluorouracil. If the tumor subsequently becomes
resectable, patients then undergo surgery.

After completion of study treatment, patients are followed periodically for 5 years and then
annually thereafter.

Inclusion Criteria:

- Patient must have newly diagnosed computated tomography (CT) and endoscopic
ultrasound(EUS) stage Tx-4, N0-1, M0 adenocarcinoma of pancreas according to the
American Joint Committee on Cancer (AJCC) staging system. The following cell types
will NOT be eligible: adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor,
cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal
carcinoma, or islet cell carcinoma

- Treatment must begin within 60 days of diagnosis

- Must have locally advanced inoperable pancreatic cancer with no metastatic spread as
determined by a baseline diagnostic CT scan of the chest, endoscopic ultrasound and
CT scan with intravenous (IV) contrast (or MRI) of abdomen/pelvis, within 30 days
prior to registration.

- No prior systemic chemotherapy or radiation therapy for pancreatic cancer

- Documented Eastern Cooperative Oncology Group (ECOG/Zubrod) performance status 0-1
within 14 days prior to registration

- Adequate hematologic, renal and hepatic function as defined by the following
laboratory values (completed within 14 days prior to registration)

- white blood cell (WBC) > 3,000 mm3

- absolute neutrophil count (ANC) > 1,500 mm3

- platelet count ≥ 100,000 mm3

- hemoglobin > 9.5 g/dl

- serum creatinine < 1.5 times institutional upper limit of normal (ULN)

- total bilirubin ≤ 3 mg/dl

- AST (SGOT) < 4.0 times institutional ULN

- ALT (SGPT) < 4.0 times institutional ULN

- alkaline phosphatase < 2.0 times institutional ULN

- Age ≥ 18 years

- Life expectancy ≥ 12 weeks

- Patient (male or female) of reproductive potential are required to use a medically
acceptable contraception during treatment and for 3 months after the last dose of

- Not pregnant or breastfeeding since the drugs used in this study are Pregnancy
Category D: Clear evidence of risk in pregnancy. A negative pregnancy test is
required within 7 days of registration if pre- or perimenopausal (i.e., last
menstrual period within one year of registration)

- If patient has a previous diagnosis of cancer, all of the following criteria must be
met and documented in the patient's medical record:

- Patient has undergone potentially curative therapy for all prior malignancies.

- No evidence of prior malignancies for at least 5 years (except for successfully
treated cervical carcinoma in situ, carcinoma in situ of the breast, or
nonmelanoma skin cancer.

- No evidence of recurrence of any prior malignancy.

- Patient who is receiving chronic immunotherapy (e.g. prednisone or methotrexate) for
collagen vascular disease or other chronic immunologic abnormality are not eligible.

- Not requiring one or more of the contraindicated medications

- Patient must be able to understand the potential risks and benefits associated with
this study. Patient able to give informed consent and would likely to comply with the
study parameters.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients in Whom Tumor Was Resectable

Outcome Description:

Tumor response is measured in terms of resectability, as measured by CT scan at 2 weeks after completion of each course. A CT scan of the chest abdomen and pelvis will be performed in order to evaluate for the presence of metastatic disease. If no metastatic disease, emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. If potential for resection then surgery will be recommended. This protocol will be followed after each cycle.

Outcome Time Frame:

Up to 5 Years or Until Disease Progression

Safety Issue:


Principal Investigator

Edward W. Greeno, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

January 2005

Completion Date:

August 2011

Related Keywords:

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



Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455