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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Charles S. Fuchs, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00251355
First received: November 8, 2005
Last updated: April 29, 2014
Last verified: April 2014

November 8, 2005
April 29, 2014
January 1998
June 2007   (final data collection date for primary outcome measure)
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 ]
To assess the maximum tolerated dose of weekly gemcitabine when administered with continuous infusion 5-fluorouracil and external beam radiation.
Complete list of historical versions of study NCT00251355 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To determine the safety if this regimen
  • to obtain a preliminary assessment of the efficacy of this regimen in this patient population.
Not Provided
Not Provided
 
Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Non-Metastatic Pancreatic Cancer
A Phase I Study of Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Locally Unresectable Non-Metastatic Pancreatic Cancer

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.

  • 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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • 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.
Experimental: 5-FU/gemcitabine/RT
Interventions:
  • Drug: Gemcitabine
  • Drug: 5-Fluorouracil
  • Procedure: Radiation Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2014
June 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 72 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00251355
97-105
Yes
Charles S. Fuchs, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
Principal Investigator: Charles S. Fuchs, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP