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| Descriptive Information Fields | |
| Brief Title † | A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas |
| Official Title † | A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas |
| Brief Summary | Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327. |
| Detailed Description | 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. |
| Study Phase | Phase I |
| Study Type † | Interventional |
| Study Design † | Treatment, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Gastrointestinal Neoplasms Pancreatic Neoplasms |
| Intervention † | Drug: gemcitabine |
| MEDLINE PMIDs | 6313514, 2579295 |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 20 |
| Start Date † | February 1995 |
| Completion Date | November 2000 |
| Eligibility 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00001431 |
| Organization ID | 950075 |
| Secondary IDs †† | 95-C-0075 |
| Study Sponsor † | National Cancer Institute (NCI) |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | November 2000 |
| First Received Date † | November 3, 1999 |
| Last Updated Date | March 3, 2008 |