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

Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Cancer

Intervention: Gemcitabine (Drug); 5-Fluorouracil (Drug); Radiation Therapy (Procedure)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Dana-Farber Cancer Institute

Official(s) and/or principal investigator(s):
Charles S. Fuchs, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute

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.

Clinical Details

Official title: A Phase I Study of Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Locally Unresectable Non-Metastatic Pancreatic Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To assess the maximum tolerated dose of weekly gemcitabine when administered with continuous infusion 5-fluorouracil and external beam radiation.

Secondary outcome:

To determine the safety if this regimen

to obtain a preliminary assessment of the efficacy of this regimen in this patient population.

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

Minimum age: 18 Years. Maximum age: 72 Years. Gender(s): Both.

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.

Locations and Contacts

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Additional Information

Starting date: January 1998
Last updated: April 29, 2014

Page last updated: August 20, 2015

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