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
18 Years
N/A
Both
Pancreatic Cancer
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 Group | Tampa, Florida 33606 |
