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

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00251355

Purpose

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	Intervention	Phase
Pancreatic Cancer	Drug: Gemcitabine Drug: 5-Fluorouracil Procedure: Radiation Therapy	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Study of Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Locally Unresectable Non-Metastatic Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer Radiation Therapy

Drug Information available for: Fluorouracil Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To assess the maximum tolerated dose of weekly gemcitabine when administered with continuous infusion 5-fluorouracil and external beam radiation. [ Time Frame: phase 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the safety if this regimen [ Time Frame: phase 1 ] [ Designated as safety issue: Yes ]
to obtain a preliminary assessment of the efficacy of this regimen in this patient population. [ Time Frame: phase 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	January 1998
Estimated Study Completion Date:	July 2009
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Gemcitabine, IV bolus administered weekly (weeks 1-6) at least 4 hours before that day's radiation therapy.

5-FU via continuous IV infusion.

External Beam Radiotherapy (weeks 1-6), Monday through Friday.

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.

Eligibility

Ages Eligible for Study:	18 Years to 72 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251355

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

Investigators

Principal Investigator:

Charles S. Fuchs, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Charles Fuchs, MD, MPH )
Study ID Numbers:	97-105
Study First Received:	November 8, 2005
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00251355 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

gemcitabine
5-fluorouracil
5-FU
unresectable pancreatic cancer
non-metastatic pancreatic cancer

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Antiviral Agents
Immunosuppressive Agents

Digestive System Diseases
Radiation-Sensitizing Agents
Fluorouracil
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Fluorouracil
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009