A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas
A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas
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 grading system.
DISEASE CHARACTERISTICS:
Histologically or cytologically proven unresectable adenocarcinoma of the pancreas or ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills requirement.
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.
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: More than 4 weeks since immunotherapy.
Chemotherapy:
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.
Radiotherapy:
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.
Surgery:
Prior resection allowed.
Biliary decompression or gastric bypass allowed.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: ECOG 0-2.
Hematopoietic:
ANC greater than 2,000/mm(3).
Platelets greater than 100,000/mm(3).
Hepatic: AST/ALT no greater than 2.5 times normal.
Renal:
Creatinine less than 1.5 mg/dL.
Creatinine clearance at least 60 mL/min,
Cardiovascular:
No myocardial infarction within 6 months.
No unstable angina.
No congestive heart failure (NYHA class III/IV).
OTHER:
HIV seronegative.
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.