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Home > "A" Clinical Trials Conditions > 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
A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas
For Condition: Gastrointestinal Neoplasms,Pancreatic Neoplasms
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 20
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 950075; 95-C-0075
Study Start Date: February 13, 1995
Record last reviewed: November 1, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001431
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3. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
4. Study to treat Cancer-Related Cachexia in Patients with Pancreatic Cancer
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A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas
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