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

Study Overview

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

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).

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.

Pancreatic Cancer

DRUG: fluorouracil
DRUG: gemcitabine hydrochloride
RADIATION: brachytherapy
RADIATION: phosphorus P32
RADIATION: radiation therapy

CDR0000355400
USFPG-6034

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2004-03-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-12-03
First Submitted that Met QC Criteria 2004-03-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-12-04
First Posted (ESTIMATED) 2004-03-10	Results First Posted N/A	Last Verified 2005-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

18 and over

Karnofsky 60-100%

Not specified

Absolute neutrophil count: ≥ 1,500/mm^3
Platelet count ≥ 50,000/mm^3
Hemoglobin ≥ 10 g/dL

Bilirubin < 2 times upper limit of normal (ULN)
AST and ALT < 5 times ULN
Alkaline phosphatase < 5 times ULN
Albumin ≥ 2.5 mg/dL

Creatinine ≤ 1.5 mg/dL

See Disease Characteristics

See Disease Characteristics

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

Not specified

Not specified

Not specified

No prior radiotherapy for pancreatic adenocarcinoma

See Disease Characteristics

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Alexander Rosemurgy, MD, University of South Florida

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record