MedDataX Logo

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

NCT ID: NCT00251355

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

5-FU/gemcitabine/RT

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

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

5-Fluorouracil

Intervention Type DRUG

5-FU via continuous IV infusion.

Radiation Therapy

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gemcitabine

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

Intervention Type DRUG

5-Fluorouracil

5-FU via continuous IV infusion.

Intervention Type DRUG

Radiation Therapy

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Charles S. Fuchs, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Charles S. Fuchs, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

97-105

Identifier Type: -

Identifier Source: org_study_id