Tissue Pharmacokinetics of Intraoperative Gemcitabine in Resectable Adenocarcinoma of the Pancreas
This trial is active, not recruiting.
|Sponsor||M.D. Anderson Cancer Center|
|Start date||January 2011|
|End date||March 2018|
|Trial size||18 participants|
|Trial identifier||NCT01276613, 2010-0371, NCI-2011-00244|
The goal of this clinical research study is to learn if gemcitabine can enter pancreas cancer cells.
|Endpoint classification||pharmacokinetics study|
|Intervention model||single group assignment|
Intratumoral Gemcitabine Levels in Human Pancreatic Cancer Tissue
time frame: Collection during surgery, participants followed 30 days post surgery
Gemcitabine DNA Levels in Human Pancreatic Cancer Tissue
time frame: Before surgery, participants followed 30 days post surgery
Effect of Losartan on Gemcitabine DNA Incorporation Human Pancreatic Cancer Tissue
time frame: Before surgery, participants followed 30 days post surgery
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Cytologic or histologic proof of adenocarcinoma of the pancreas is required. Patients with Islet cell tumors are not eligible. 2. Patients do not have known metastases. 3. Patients must have potentially resectable pancreatic cancer and have agreed to undergo surgical resection at M D Anderson Cancer Center. They will have undergone staging (physical examination, chest x-ray, contrast enhanced CT or MRI (if CT contraindicated) and/or angiogram to determine resectability. Potentially resectable is defined as:No extra-pancreatic disease; No evidence (on CT/MRI) of tumor extension to the celiac axis or SMA; No evidence (CT/MRI or angiogram) of occlusion of the SMV or SMPV confluence. 4. Patients with a Karnofsky performance status greater than 70 are eligible. 5. There will be no upper age restriction. Patients less than 18 years of age are excluded from the protocol because adenocarcinoma of the pancreas is rarely seen in the pediatric population. 6. Adequate renal, and bone marrow function: Leukocytes >= 3,000/uL; Absolute neutrophil count >= 1,500/uL; Platelets >= 100,000/Ul; Serum creatinine <= 2.0 mg/dL. 7. Adequate Hepatic function (endoscopic or percutaneous drainage as needed): Total bilirubin < = 3 X institutional upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) <= 5 X institutional ULN. 8. Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude administration of gemcitabine. Patients with uncontrolled congestive heart failure, unstable angina and myocardial infarction within 3 months will be excluded. 9. Patient is not pregnant. Women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent. 10. Patients must sign a study-specific consent form. Exclusion Criteria: 1. Patient has received preoperative chemotherapy and/or radiation. 2. Major cardiovascular or pulmonary comorbidity that precludes use of general anesthesia. 3. Identification of metastatic disease. 4. Inability to comply with study and/or follow-up procedures. 5. Patients < 18 years of age.
|Official title||Tissue Pharmacokinetics of Intraoperative Gemcitabine in Resectable Adenocarcinoma of the Pancreas|
|Principal investigator||Jason B Fleming, MD|
|Description||The Study Drug: Gemcitabine is a drug used to treat pancreatic cancer. However, there are no studies that show that gemcitabine is able to enter pancreatic cancer cells. Surgery: Your surgery will be performed in the same way as it would be even if you were not taking part in this study. You will sign a separate consent form for surgery. The length of the surgery and the time you are under anesthesia are not changed by taking part in the study. To try to find out if gemcitabine enters pancreas cancer cells, participants who are having their pancreatic cancer removed by surgery will receive an infusion of gemcitabine during the surgery. Some of the pancreatic cancer tissue removed then will be checked to learn if gemcitabine is found in the cancer cells. During surgery, you will have routine procedures to learn if the disease has spread to other areas. If the disease has spread beyond the pancreas, surgical removal is not possible. If for any reason during the surgery, the surgeon decides that removal of the pancreas is not possible, you will not receive gemcitabine and your participation in this study will end. If there are no signs of spread or other reasons the cancer cannot be removed, the surgeon will begin the process of removal of the disease. Gemcitabine Infusion: You will receive an infusion of gemcitabine just before the surgeon begins to remove the cancer. Gemcitabine will be given through an infusion catheter that is placed in the operating room after you are asleep. The infusion will take over either 50 or 100 minutes, depending upon when you joined the study. The first 2 participants will receive gemcitabine over 50 minutes and the rest of the participants (up to 18) will receive gemcitabine over 100 minutes. The infusion catheter is not required for the study but is a standard of care procedure for all participants who are having pancreatic cancer surgery. You will sign a separate consent form for the infusion catheter. Blood and Tissue Collection: Up to 10 blood samples (about 1 tablespoon each time) will be drawn during surgery starting before the gemcitabine infusion begins and at the end of surgery. The blood samples are used to measure the levels of gemcitabine in your blood at different time points. This is called pharmacokinetic (PK) testing. The blood will also be used for biomarker testing. Biomarkers are chemical "markers" in the blood/tissue that may be related to your reaction to the study drug. Some of the tumor tissue and normal tissue removed during surgery will be collected to learn if gemcitabine is able to enter the tissue cells and for biomarker testing. Length of Study: Your active participation in this study will be over once you have had surgery and completed the follow-up. The research team will continue to collect information on you for 30 days after surgery (or until you are no longer having side effects). Follow-Up: The study team will follow your health status for 30 days after surgery to check if you are having any side effects from gemcitabine. This follow-up will be done daily while you are in the hospital recovering from the surgery. Follow-up will also occur at the time of a routine clinic visit, or by phone call at least once weekly. These calls should last about 5 minutes each. This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer. Its use during surgery is investigational. Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.|
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