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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Treatments: Fluorouracil; Gemcitabine; Pancreatin; Pancrelipase

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