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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Alexander Rosemurgy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of South Florida

Authority:

United States: Federal Government

Study ID:

CDR0000355400

NCT ID:

NCT00079365

Start Date:

May 2001

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms

Name

Location

USF Physician's GroupTampa, Florida  33606