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
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Cancer
Intervention: fluorouracil (Drug); gemcitabine hydrochloride (Drug); phosphorus P32 (Drug); brachytherapy (Procedure); chemotherapy (Procedure); radiation therapy (Procedure); radioisotope therapy (Procedure); radiosensitization (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of South Florida Official(s) and/or principal investigator(s):
Alexander Rosemurgy, MD, Study Chair, Affiliation: University of South Florida
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).
Clinical Details
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 design: Treatment, Randomized, Active Control
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
USF Physician's Group, Tampa, Florida 33606, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: May 2001
Last updated: January 26, 2008
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