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A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas Clinical research trials and A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 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 Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas clinical trial. Test subjects typically receive the most expert healthcare available for their A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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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
Other Pancreatic Neoplasms Studies:
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2. Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer
3. A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab
4. A Phase 3 Trial of ALIMTA (LY231514, pemetrexed) plus GEMZAR Versus GEMZAR in Patients with Unresectable or Metastatic Cancer of the Pancreas.
5. Study of Gemcitabine Chemoradiation and TNP-470 Patients Locally Advanced, Nonmetastatic Adenocarcinoma of Pancreas
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A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas
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