Combination Chemotherapy and Radiation Therapy Plus Surgery in Treating Patients With Advanced Cancer of the Pancreas
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stage IVA Pancreatic Cancer; Stage III Pancreatic Cancer; Adenocarcinoma of the Pancreas
Intervention: fluorouracil (Drug); gemcitabine (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: National Cancer Institute (NCI) Official(s) and/or principal investigator(s):
David L. Bartlett, Study Chair, Affiliation: National Cancer Institute (NCI)
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Giving the drugs in different ways, such as directly into the
abdomen, and combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation
therapy plus surgery in treating patients who have advanced cancer of the pancreas.
Clinical Details
Official title: Phase II Study of Neoadjuvant Intraperitoneal Gemcitabine and Intravenous Gemcitabine With Radiotherapy Followed by Surgery and Adjuvant Intraperitoneal Gemcitabine, Intravenous Gemcitabine, and Fluorouracil in Patients With Advanced Adenocarcinoma of the Pancreas
Study design: Treatment
Detailed description:
OBJECTIVES: I. Determine radiographic and/or pathologic response, time to disease
progression, and survival in patients with advanced adenocarcinoma of the pancreas treated
with neoadjuvant intraperitoneal gemcitabine and intravenous gemcitabine with radiotherapy
followed by surgery and adjuvant intraperitoneal gemcitabine, intravenous gemcitabine, and
fluorouracil.
II. Determine the pharmacokinetics of intraperitoneal gemcitabine in these patients.
III. Correlate patterns of mRNA expression with response to this regimen and prognosis in
these patients.
PROTOCOL OUTLINE: Patients receive gemcitabine intraperitoneally (IP) every 6 hours for 4
doses on day 1. Treatment repeats in 1 week for a total of 2 courses. Beginning 1-3 weeks
after completion of IP chemotherapy, patients receive gemcitabine IV over 30-60 minutes on
day 1 or 2 of each week and radiotherapy on days 1-5 of each week for 6 weeks. Within 6
weeks after the completion of combination chemotherapy and radiotherapy, patients with stable
or responding disease undergo surgical resection. Patients with completely resected
extrapancreatic disease then receive 2 additional courses of IP gemcitabine beginning 1-3
weeks after surgery. Beginning 3 weeks after the completion of IP chemotherapy, patients
receive gemcitabine IV once weekly for a total of 3 weeks and fluorouracil IV continuously
for up to 6 months.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6
months for 3 years.
PROJECTED ACCRUAL:
A total of 10-100 patients will be accrued for this study within 2 years.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics-- Histologically or cytologically confirmed adenocarcinoma of the
pancreas or ampullae of vater not amenable to curative surgery Metastases confined to
abdominal cavity May include peripancreatic lymph nodes, peritoneal carcinomatosis, and
hepatic metastases Extrapancreatic disease must be resectable Must have progressive disease
if received any prior therapy No distant metastases, including lung or bone metastases
- -Prior/Concurrent Therapy-- Biologic therapy: No concurrent immunotherapy for pancreatic
cancer Chemotherapy: No prior gemcitabine or fluorouracil Endocrine therapy: No concurrent
hormonal therapy for pancreatic cancer Radiotherapy: No prior radiotherapy for pancreatic
cancer No prior abdominal or pelvic radiotherapy Surgery: See Disease Characteristics
Other: At least 30 days since prior anticancer therapy and recovered - -Patient
Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 Platelet count
greater than 100,000/mm3 Hepatic: SGOT and SGPT less than 4 times upper limit of normal No
active hepatitis Renal: Creatinine less than 1. 5 mg/dL OR Creatinine clearance greater than
60 mL/min Cardiovascular: No significant reversible ischemic changes in wall motion or
perfusion with stress (correction using angiography and angioplasty allowed) No significant
resting left ventricle dysfunction No unstable angina No New York Heart Association class
III or IV heart disease No myocardial infarction within past 6 months Other: Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception No
active disease increasing possibility of infection, including AIDS and other autoimmune
disorders No other medical condition or psychiatric disease that would preclude study No
other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the
cervix
Locations and Contacts
Radiation Oncology Branch, Bethesda, Maryland 20892, United States
Surgery Branch, Bethesda, Maryland 20892, United States
Additional Information
Starting date: September 2000
Last updated: March 2, 2007
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