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Combination Chemotherapy and Radiation Therapy Plus Surgery in Treating Patients With Advanced Cancer of the Pancreas
This study is ongoing, but not recruiting participants.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020345
  Purpose

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.


Condition Intervention Phase
Stage IVA Pancreatic Cancer
Stage III Pancreatic Cancer
Adenocarcinoma of the Pancreas
Drug: fluorouracil
Drug: gemcitabine
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Fluorouracil Pancrelipase Ultrase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2000
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

Ages Eligible for Study:   18 Years and older
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020345

Locations
United States, Maryland
Radiation Oncology Branch
Bethesda, Maryland, United States, 20892
Surgery Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Study Chair: David L. Bartlett National Cancer Institute (NCI)
  More Information

Study ID Numbers: CDR0000068298, NCI-00-C-0218
Study First Received: March 2, 2007
Last Updated: March 2, 2007
ClinicalTrials.gov Identifier: NCT00020345  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancrelipase
Carcinoma
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009