Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate 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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Closed	18 and over	Other	USFPG-6034 NCT00079365

Objectives

Primary

1. 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

1. Compare time to disease progression, tumor response rate, and physical performance in patients treated with these regimens.
2. Compare the safety and tolerability of these regimens in this patient population.
3. Compare duration of response and time to treatment failure in patients treated with these regimens.

Entry 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)

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count: ≥ 1,500/mm³
• Platelet count ≥ 50,000/mm³
• 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

Expected Enrollment

A total of 80 patients (40 per treatment arm) will be accrued for this study within 24-30 months.

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.

Trial Contact Information

Trial Lead Organizations

USF Physician's Group

Alexander Rosemurgy, MD, Protocol chair		Ph: 813-844-7393; 888-873-3627

Registry Information
Official Title		A Randomized Trial Comparing 5-Fluorouracil, External Beam Radiation, and Gemcitabine With or Without 32P Radiopharmaceutical Therapy As A First Line Therapy in Patients With Locally/Regionally Advanced Non-Resectable Adenocarcinoma of the Pancreas
Trial Start Date		2001-05-16
Registered in ClinicalTrials.gov		NCT00079365
Date Submitted to PDQ		2004-02-04
Information Last Verified		2005-05-25

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