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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Stage IVA Pancreatic Cancer, Stage III Pancreatic Cancer, Adenocarcinoma of the Pancreas

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David L. Bartlett

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

000218

NCT ID:

NCT00020345

Start Date:

September 2000

Completion Date:

March 2002

Related Keywords:

  • Stage IVA Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Adenocarcinoma of the Pancreas
  • adenocarcinoma of the pancreas
  • adult solid tumor
  • body system/site cancer
  • cancer
  • cellular diagnosis, pancreatic cancer
  • gastrointestinal cancer
  • pancreatic cancer
  • solid tumor
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • stage IVA pancreatic cancer
  • stage, pancreatic cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms

Name

Location

Radiation Oncology BranchBethesda, Maryland  20892
Surgery BranchBethesda, Maryland  20892