Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Non-Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251355
Recruitment Status : Completed
First Posted : November 10, 2005
Last Update Posted : December 20, 2016
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Charles S. Fuchs, MD, Dana-Farber Cancer Institute

Brief Summary:
The purpose of this study is to test a new treatment of pancreatic cancer that cannot be removed by surgery. This treatment is a Phase I dose escalation research study which will combine one drug at increasing doses with a fixed dose of a second drug and radiation therapy. The drug that will be used at increasing doses is gemcitabine whereas 5-fluorouracil will remain the same for all patients.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine Drug: 5-Fluorouracil Procedure: Radiation Therapy Phase 1

Detailed Description:
  • Ultimately we plan to find the maximum tolerated dose of the combination of gemcitabine, 5-fluorouracil and radiation therapy. We also hope to assess the number of people who respond to this therapy and to assess the feasibility of giving intraoperative radiation therapy following gemcitabine, 5-fluorouracil, and external beam radiation therapy.
  • A surgical procedure, either laparotomy or laparoscopy, will be required to check the amount of disease before treatment is started.
  • All patients will receive the same two chemotherapy drugs and radiation therapy. Both gemcitabine and 5-fluorouracil will begin on the first week of radiation therapy. 5-fluorouracil will be given continuously by intravenous infusion and will continue until the external beam radiation therapy is completed. The gemcitabine will be given (at different doses for each cohort of patients) once per week for seven weeks. Radiation therapy will be given daily for five days for seven weeks. On those days when gemcitabine is given, radiation therapy will be given approximately four hours after the gemcitabine dose.
  • Four weeks after completing the radiation therapy and chemotherapy, patients will undergo a scan to check the extent of disease. Following the scan, patients will be considered for a repeat surgical procedure to remove the tumor, if possible. If removal of the tumor is not possible, patients will receive intraoperative radiation therapy.
  • After completing the therapy, patients will be seen at least every 3 months for one year. A complete physical exam and CT scan will be done regularly.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Locally Unresectable Non-Metastatic Pancreatic Cancer
Study Start Date : January 1998
Actual Primary Completion Date : June 2007
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 5-FU/gemcitabine/RT Drug: Gemcitabine
Gemcitabine, IV bolus administered weekly (weeks 1-6) at least 4 hours before that day's radiation therapy.

Drug: 5-Fluorouracil
5-FU via continuous IV infusion.

Procedure: Radiation Therapy
External Beam Radiotherapy (weeks 1-6), Monday through Friday.

Primary Outcome Measures :
  1. To assess the maximum tolerated dose of weekly gemcitabine when administered with continuous infusion 5-fluorouracil and external beam radiation. [ Time Frame: phase 1 ]

Secondary Outcome Measures :
  1. To determine the safety if this regimen [ Time Frame: phase 1 ]
  2. to obtain a preliminary assessment of the efficacy of this regimen in this patient population. [ Time Frame: phase 1 ]

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologic confirmation of locally unresectable pancreatic adenocarcinoma. Patients with either measurable of evaluable disease are eligible.
  • Unresectable, non-metastatic tumors. Unresectable patients include those with local extension of the tumor into adjacent structures and/or nodal metastasis.
  • Total bilirubin < 2.0 mg/dl
  • AST < 3x ULN
  • Serum creatinine < 2.0 mg/dl
  • WBC > 3,000/mm3
  • Platelets > 100,000/mm3
  • ECOG performance status < or = to 2
  • Life expectancy of greater than 12 weeks

Exclusion Criteria:

  • Evidence of peritoneal seeding by malignancy
  • Prior radiation therapy or chemotherapy for pancreatic cancer
  • Myocardial infarction in the past 6 months
  • Major surgery in past two weeks
  • Uncontrolled serious medical or psychiatric illness
  • Pregnant or lactating women
  • Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251355

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Principal Investigator: Charles S. Fuchs, MD Dana-Farber Cancer Institute

Responsible Party: Charles S. Fuchs, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00251355     History of Changes
Other Study ID Numbers: 97-105
First Posted: November 10, 2005    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016

Keywords provided by Charles S. Fuchs, MD, Dana-Farber Cancer Institute:
unresectable pancreatic cancer
non-metastatic pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs