Status:
UNKNOWN
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
Lead Sponsor:
University of South Florida
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-...
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 gemc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00079365
Start Date
May 1 2001
Last Update
December 4 2013
Active Locations (1)
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1
USF Physician's Group
Tampa, Florida, United States, 33606