Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation
using 4-15 MV photons; plus Gemcitabine, NSC-613327.
This is a Phase I trial of gemcitabine given weekly as a 30 minute infusion administered
concurrently with radiation in patients with locally advanced or locally recurrent
pancreatic carcinoma. Patients will be treated with external beam radiation therapy in a
standard manner. Gemcitabine will be administered as a 30 minute infusion beginning on the
first day of irradiation and weekly afterwards for a total of 5 doses. Patients will be
assessed clinically for acute toxicity which will be graded per RTOG and DCT toxicity
Histologically or cytologically proven unresectable adenocarcinoma of the pancreas or
ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills
Unresectable disease defined as tumor with: Gross involvement of regional nodes or direct
extension to any of the following sites: Duodenum, Spleen, Bile duct , Colon,
Peripancreatic tissue, Adjacent large vessels, Stomach.
Metastatic disease requiring local radiotherapy allowed. No CNS metastasis.
No lymphomas or neuroendocrine tumors.
No peritoneal carcinomatosis.
Biologic Therapy: More than 4 weeks since immunotherapy.
No prior chemotherapy for newly diagnosed disease.
More than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas,
mitomycin, or suramin).
Endocrine Therapy: More than 4 weeks since hormonal therapy.
No prior radiotherapy for newly diagnosed disease.
No prior abdominal or pelvic radiotherapy.
More than 4 weeks since radiotherapy for recurrent disease. No prior radiotherapy for
locally advanced disease after resection allowed.
Prior resection allowed.
Biliary decompression or gastric bypass allowed.
Age: 18 and over.
Performance status: ECOG 0-2.
ANC greater than 2,000/mm(3).
Platelets greater than 100,000/mm(3).
Hepatic: AST/ALT no greater than 2.5 times normal.
Creatinine less than 1.5 mg/dL.
Creatinine clearance at least 60 mL/min,
No myocardial infarction within 6 months.
No unstable angina.
No congestive heart failure (NYHA class III/IV).
No medical or psychiatric contraindication to protocol therapy.
No concurrent malignancy other than: Skin cancer, Cervical carcinoma in situ.
No pregnant or nursing women.
Adequate contraception required of fertile patients.