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

Sponsor

University of South Florida (Other)

Overall Status

Unknown status

CT.gov ID

NCT00079365

Collaborator

(none)

Location

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: fluorouracil Drug: gemcitabine hydrochloride Radiation: brachytherapy Radiation: phosphorus P32 Radiation: radiation therapy	N/A

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

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 Start Date :

May 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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