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Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fluorouracil
gemcitabine hydrochloride
brachytherapy
phosphorus P32
radiation therapy
Sponsored by
University of South Florida
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed pancreatic adenocarcinoma Locally or regionally advanced disease Unresectable disease defined by the following: Invasion into a major vascular structure determined preoperatively by a CT scan, angiogram, or CT portogram or intraoperatively by surgeon Severe comorbidities precluding operation, such as congestive heart failure, coronary artery disease, or chronic obstructive pulmonary disease Bidimensionally measurable disease by CT scan No recurrent disease No previously resected pancreatic cancer No tumors of the pancreas not ductal in origin (e.g., islet cell tumors, lymphoma, or sarcoma) PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count: ≥ 1,500/mm^3 Platelet count ≥ 50,000/mm^3 Hemoglobin ≥ 10 g/dL Hepatic Bilirubin < 2 times upper limit of normal (ULN) AST and ALT < 5 times ULN Alkaline phosphatase < 5 times ULN Albumin ≥ 2.5 mg/dL Renal Creatinine ≤ 1.5 mg/dL Cardiovascular See Disease Characteristics Pulmonary See Disease Characteristics Other No other malignancy within the past 5 years except curatively resected basal cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or early stage prostate cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No prior radiotherapy for pancreatic adenocarcinoma Surgery See Disease Characteristics Other No prior chromic phosphate P32 suspension (Phosphocol®) At least 4 weeks since prior cytotoxic therapy for pancreatic adenocarcinoma At least 4 weeks since prior investigational anti-tumoral agents No other concurrent investigational agents No other concurrent anticancer agents

Sites / Locations

  • USF Physician's Group

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2004
Last Updated
December 3, 2013
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00079365
Brief Title
Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas
Official Title
A Randomized Trial Comparing 5-Fluorouracil, External Beam Radiation, and Gemcitabine With or Without P Radiopharmaceutical Therapy As A First Line Therapy in Patients With Locally/Regionally Advanced Non-Resectable Adenocarcinoma of the Pancreas
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of South Florida

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Fluorouracil may make the tumor cells more sensitive to radiation therapy. Brachytherapy uses radioactive material, such as phosphorus P32, placed directly into or near a tumor to kill tumor cells. Combining chemotherapy and external-beam radiation therapy with brachytherapy may kill more tumor cells. PURPOSE: This randomized clinical trial is studying fluorouracil, gemcitabine, external-beam radiation therapy, and brachytherapy using phosphorus P32 to see how well they work compared to fluorouracil, gemcitabine, and external-beam radiation therapy in treating patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas (pancreatic cancer).
Detailed Description
OBJECTIVES: Primary Compare the survival of patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas treated with fluorouracil, external beam radiotherapy, and gemcitabine with vs without brachytherapy with phosphorus P32 suspension. Secondary Compare time to disease progression, tumor response rate, and physical performance in patients treated with these regimens. Compare the safety and tolerability of these regimens in this patient population. Compare duration of response and time to treatment failure in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive phosphorus P32 suspension percutaneously under CT guidance on day 0 and at months 1, 2, 6, 7, and 8. Patients receive fluorouracil IV continuously on days 1-5 of weeks 1-6. Patients concurrently undergo external beam radiotherapy 5 days a week on weeks 1-6. At the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes once weekly for 7 weeks. After a 1-week rest, patients then receive gemcitabine IV over 30 minutes once weekly for 3 weeks. Treatment repeats every 28 days. Arm II: Patients receive fluorouracil and gemcitabine and undergo external beam radiotherapy as in arm I. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 24-30 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Radiation
Intervention Name(s)
phosphorus P32
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed pancreatic adenocarcinoma Locally or regionally advanced disease Unresectable disease defined by the following: Invasion into a major vascular structure determined preoperatively by a CT scan, angiogram, or CT portogram or intraoperatively by surgeon Severe comorbidities precluding operation, such as congestive heart failure, coronary artery disease, or chronic obstructive pulmonary disease Bidimensionally measurable disease by CT scan No recurrent disease No previously resected pancreatic cancer No tumors of the pancreas not ductal in origin (e.g., islet cell tumors, lymphoma, or sarcoma) PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count: ≥ 1,500/mm^3 Platelet count ≥ 50,000/mm^3 Hemoglobin ≥ 10 g/dL Hepatic Bilirubin < 2 times upper limit of normal (ULN) AST and ALT < 5 times ULN Alkaline phosphatase < 5 times ULN Albumin ≥ 2.5 mg/dL Renal Creatinine ≤ 1.5 mg/dL Cardiovascular See Disease Characteristics Pulmonary See Disease Characteristics Other No other malignancy within the past 5 years except curatively resected basal cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or early stage prostate cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No prior radiotherapy for pancreatic adenocarcinoma Surgery See Disease Characteristics Other No prior chromic phosphate P32 suspension (Phosphocol®) At least 4 weeks since prior cytotoxic therapy for pancreatic adenocarcinoma At least 4 weeks since prior investigational anti-tumoral agents No other concurrent investigational agents No other concurrent anticancer agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Rosemurgy, MD
Organizational Affiliation
University of South Florida
Official's Role
Study Chair
Facility Information:
Facility Name
USF Physician's Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas

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