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Home > "I" Clinical Trials Conditions > Intraperitoneal and Intravenous Gemcitabine, Radiotherapy and Surgery for Advanced Cancer of the Pancreas  Intraperitoneal and Intravenous Gemcitabine, Radiotherapy and Surgery for Advanced Cancer of the Pancreas
Intraperitoneal and Intravenous Gemcitabine, Radiotherapy and Surgery for Advanced Cancer of the Pancreas
For Condition: Pancreatic Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will determine the safety and effectiveness of treating advanced cancer of the pancreas with the anticancer drug gemcitabine given directly into the abdomen (intraperitoneally) and then through a vein (intravenously) along with radiation therapy. Patients 18 years of age or older with pancreatic cancer that has not spread beyond the abdomen may be eligible for this study. Candidates will have a physical examination, chest X-ray, blood tests, electrocardiogram, computed tomography (CT) scan of the chest, abdomen and pelvis, and will fill out a quality of life questionnaire. Participants will have a laparoscopy. Done under general anesthesia, this procedure involves inserting a laparoscope-a thin, flexible tube with a light and special fibers at the end-into the abdomen through a small incision. Through this device, the surgeon can see the tumor and remove a piece of it for microscopic examination. During the laparoscopy, a special tube called a Tenckhoff catheter will be placed in the abdomen, and one end will come out through the skin after the incision is closed. Chemotherapy will be delivered directly into the abdomen through this catheter. Patients will then undergo the following procedures: Intraperitoneal gemcitabine. Patients will be given gemcitabine, mixed with a warm fluid, directly into the abdomen through the Tenckhoff catheter. After 6 hours, any fluid that has not been absorbed will be removed and another dose will be administered. This treatment will be repeated every 6 hours for 24 hours. During the treatment, samples of blood and of fluid from the abdomen will be taken to measure levels of the drug. Patients will remain in the hospital 48 to 72 hours. Chemotherapy and radiation therapy. About 1 to 3 weeks after the intraperitoneal gemcitabine treatment, patients will have 2 days of intravenous gemcitabine (in 30- to 60-minute infusions) followed by 5 days of radiation therapy. This 7-day treatment cycle will be repeated weekly for 6 weeks. Surgery. About 6 weeks after completing the intraperitoneal and intravenous gemcitabine therapy, patients will have their tumors evaluated to determine the response to treatment. Those whose tumors remained stable or shrunk will undergo surgery to remove them. Patients whose tumors did not respond will be taken off the study. Repeat intraperitoneal gemcitabine. Patients whose tumors outside the pancreas (as well as tumors within the pancreas, if possible) are successfully removed will receive 2 more cycles of intraperitoneal gemcitabine 1 to 3 weeks after the surgery. All other patients will be taken off the study. Maintenance chemotherapy. About 3 weeks after the repeat peritoneal gemcitabine, patients will receive intravenous gemcitabine over 30 minutes every week for 3 weeks followed by 1 week of rest. Another anticancer drug called 5-fluorouracil (5-FU) will be given continuously through the IV catheter via a portable pump carried like a "fanny pack" or over the shoulder. Treatment may continue for up to 6 months. Tumor response will be evaluated very 3 months during treatment, then every 3 months for the first year after treatment, every 4 months during the second year, and then every 6 months for a total of 5 years of follow-up.
Details: This is a Phase II study for patients with primary adenocarcinoma of the pancreas which is locally unresectable and/or associated with small volume, resectable metastases to the peritoneal surface, regional lymph nodes, and/or liver. Treatment consists of 2 cycles of weekly intraperitoneal gemcitabine delivered as four 6-hour exchanges of 2 liters containing 50 mg/m(2) gemcitabine over 24 hours. Patients will then be treated with bolus intravenous gemcitabine administered concurrently with radiotherapy in a standard manner over 6 weeks. Patients will be assessed for resectability after treatment and may undergo a surgical debulking procedure. Patients who are completely debulked of all extrapancreatic disease will undergo 2 repeated cycles of weekly intraperitoneal gemcitabine as described. All patients will then be treated with a combination of once weekly intravenous gemcitabine for 3 weeks followed by 1 week of rest and prolonged venous infusion of 5-FU for up to 6 months, designed as an anti-angiogenic dosing strategy to prevent recurrence. Patients will be assessed clinically for toxicity, tumor response, progression free survival and overall survival. The pharmacokinetics of intraperitoneal gemcitabine will be studied, and tumor mRNA expression will be examined for patterns of gene expression which may predict prognosis and chemotherapy response.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Eligible patients must have histologically or cytologically proven measurable adenocarcinoma of the pancreas or ampullae of Vater. Metastases must be confined to the abdominal cavity including peripancreatic lymph nodes, peritoneal carcinomatosis, and hepatic metastases. All extrapancreatic disease must be surgically resectable. Patients who do not have histologic verification at the time of enrollment may be enrolled and histology must be verified by biopsy during laparoscopy in order to continue on study. Patients must sign an informed consent. Patients must have an ECOG performance status of less than or equal to 2. Patients must have a serum creatinine of less than 1.5 mg/L or creatinine clearance of greater than 60 mL/hr; SGOT and SGPT of less than 4 times the upper limit of normal. Patients must have an ANC of greater than 2000/mm(3) and a platelet count of greater than 100,000/mm(3). Patients must be at least 18 years of age. Patients of all racial and gender groups will be included. Patients who have had prior therapy must have documented progressive disease. Patients must be willing to complete a Durable Power of Attorney. Patients must not have received any prior gemcitabine, 5-FU or radiation therapy for pancreatic cancer. Patients must not be receiving concurrent hormonal or immunotherapy treatment for pancreatic cancer. Patients must not have received any antitumor therapy within 30 days of protocol eligibility. Patients must have recovered from any prior treatment related toxicity. Patients must not have evidence of distant metastases outside of abdominal viscera, including lung metastases and bone metastases. Patients must not have concurrent second malignancies other than non-melanoma skin cancer or cervical carcinoma in situ. Patients must not have medical conditions that preclude their undergoing surgery or receiving therapy or follow-up, or have psychiatric disease which would prevent adequate informed consent or render receiving this therapy unsafe. Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g., age greater than 70, Q waves on EKG, history of angina, history of ventricular ectopy requiring treatment, or long standing (>12 months) diabetes), will undergo cardiac evaluation. Patients with significant reversible ischemic changes in wall motion or perfusion with stress, or who have significant resting LV dysfunction as defined by the normal values specific to each test will be excluded. Patients may be eligible after coronary angiography and angioplasty if reversible ischemic changes are corrected. Pregnant or nursing patients are excluded due to the unknown effects of this therapy on the unborn or nursing child. Patients who have received prior abdominal or pelvic irradiation are excluded. No patients with recent myocardial infarction (less than 6 months prior), unstable angina or congestive heart failure (NYHA class 3 or 4). No patients with active disease which makes them more susceptible to infection including but not limited to AIDS, hepatitis, autoimmune disorders, because the experimental treatment to be evaluated in this protocol may be unsafe in the absence of an intact immune system.
Total Enrollment: 100
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000218; 00-C-0218
Study Start Date: September 19, 2000
Record last reviewed: March 8, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006288
Other Pancreatic Cancer Studies:
1. Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
2. OSI-774 (Tarceva) Plus Gemcitabine in Patients with Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.
3. LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
4. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
5. Biological Therapy in Treating Patients With Metastatic Cancer
Related Studies:
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Other Maryland Clinical Trials
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Intraperitoneal and Intravenous Gemcitabine, Radiotherapy and Surgery for Advanced Cancer of the Pancreas
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