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CompletedNCT00251355Updated Dec 20, 2016

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

A Phase 1 interventional study of Gemcitabine and 5-Fluorouracil in Pancreatic Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 3 sites in United States. Open to participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2016-12-20.

Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 72 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Pancreatic Cancer

Keywords

  • gemcitabine
  • 5-fluorouracil
  • 5-FU
  • unresectable pancreatic cancer
  • non-metastatic pancreatic cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 40 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 72 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    5-FU/gemcitabine/RT

    Drug: Gemcitabine · Drug: 5-Fluorouracil · Procedure: Radiation Therapy

Interventions

  • DrugGemcitabine

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

  • Drug5-Fluorouracil

    5-FU via continuous IV infusion.

  • ProcedureRadiation Therapy

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

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

3 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00251355
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital
Responsible party
Charles S. Fuchs, MD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Nov 10, 2005
Start date
Jan 1998
Primary completion
Jun 2007
Completion
Aug 2008
Last update
Dec 20, 2016

Study contacts

Charles S. Fuchs, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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