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Pancreatic Neoplasms clinical trials

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NCT ID: NCT00690300 Recruiting - Pancreas Neoplasms Clinical Trials

Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer

Start date: January 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy.

NCT ID: NCT00551057 Recruiting - Clinical trials for Pancreatic Neoplasms

Expression of Inflammatory Proteins in Pancreatic Cancer

Start date: October 2007
Phase: N/A
Study type: Observational

The purpose of this trial is to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue.

NCT ID: NCT00541021 Recruiting - Pancreatic Cancer Clinical Trials

Gemcitabine With or Without Sorafenib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Start date: December 2006
Phase: Phase 3
Study type: Interventional

RATIONALE: Drugs used in chemotherapy such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving gemcitabine together with sorafenib is more effective than giving gemcitabine alone in treating pancreatic cancer. PURPOSE: This randomized phase III trial is studying giving gemcitabine together with sorafenib to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.

NCT ID: NCT00486460 Recruiting - Pancreatic Cancer Clinical Trials

Phase III Trial of Gemcitabine, Curcumin and Celebrex in Patients With Advance or Inoperable Pancreatic Cancer

Start date: June 2005
Phase: Phase 3
Study type: Interventional

Pancreatic cancer is an aggressive disease with an extremely poor prognosis. It is the forth leading cause of cancer-related fatalities, with an estimated one-year and five-year survival rate of 21% and 5%, respectively. Despite recent progress, the median survival time is 6-10 months for patients with locally advanced disease and 3-6 months for metastatic disease (1). The anti-metabolite gemcitabine has become the standard chemotherapy for locally advanced and metastatic pancreatic cancer, after demonstrating an improved rate of clinical benefit response and an overall survival advantage over 5-FU (2). In addition to its clinical effectiveness gemcitabine has a manageable toxicity profile, making it an attractive agent to investigate in combination with newer agents. Series of phase III trials were conducted examining the efficacy of the combination of gemcitabine and a second cytotoxic agent, including 5-FU, cisplatin, oxaliplatin and irinotecan. These gemcitabine doublets demonstrated no survival advantage over single-agent gemcitabine (3-6). However, the rationale for continuing to study gemcitabine-based combinations remains compelling. Curcumin (diferuloylmethane) is a natural compound derived from the rhizome of Curcuma Longa, an East Indian plant, commonly called turmeric. It has been shown to possess potent anti-inflammatory and anti-oxidative properties, for which it has a long history of dietary use as a food additive. Curcumin has also a potent anti-proliferative effects against a variety of cancer cell lines in vitro, which stem from its ability to modulate many intracellular signal transduction pathways (7). Human phase I-II studies found curcumin to be safe, and indicated no dose-limiting toxicity when taken by mouth at doses up to 10 g/day (8, 9). This data, together with the dismal therapeutic options available for pancreatic cancer patients, suggest that curcumin warrants investigation in this setting. Investigators from MD Anderson Cancer Center and Rambam Medical Center in Haifa, have recently initiated, separately, a phase II study of single agent Curcumin in patients with pancreatic cancer (10). One of the lessons learned from cancer research in recent decades is that combination strategies can provide dramatic improvement in a therapy’s safety and efficacy over mono-therapeutic regiments, especially if the combined drugs differ in their mode of action. In a recent paper that was accepted for publication we demonstrated, in vitro, the mechanism, clinical importance and implications of a novel combinatorial therapy, of celecoxib and curcumin, that was discovered in our lab, in inhibiting the growth of several pancreatic cell lines. P-34 (expressing high levels of COX -2), MiaPaca (Expressing low levels of COX-2) and Panc-1 (no expression of COX -2) cell lines were exposed to different concentrations of celecoxib (0-40µM), curcumin (0-20µM) and their combination. In P-34 cells, curcumin synergistically potentiated the inhibitory effect of celecoxib on cell growth. The growth inhibition was associated with inhibition of proliferation and induction of apoptosis. These experiments further demonstrate, for the first time, that the combination effect is correlated with synergistic augmentation of apoptosis and involves down-regulation of COX-2 protein. The present study evaluates gemcitabine in combination with curcumin and celecoxib for patients with pancreatic cancer.

NCT ID: NCT00346281 Recruiting - Pancreatic Cancer Clinical Trials

32P BioSiliconTM in Addition to Gemcitabine in Pancreatic Cancer

Start date: June 2006
Phase: Phase 2
Study type: Interventional

This is the first study investigating the safety of 32P BioSilicon in patients with advanced,unresectable pancreatic cancer who are also receiving standard intravenous gemcitabine chemotherapy. The secondary aims of the study will assess the implantation procedure, localisation of 32P BioSilicon, tumour response and survival parameters. Tumours targetted with 32P BioSilicon is hypothesized to show a reduction in tumour volume and with the low radioactivity dose that is delivered intratumourally, the incidence of side effects associated with the treatment is expected to be low. Prologation of survival and improved quality of life could be favourable outcomes of the investigational product.

NCT ID: NCT00323583 Recruiting - Clinical trials for Stage III Pancreatic Cancer

Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer

Start date: May 2006
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, oxaliplatin, leucovorin and 5-fluoruracil, work in different ways separately and in combination to stop tumor cells from dividing so they stop growing or die. The use of metronomic dosing of chemotherapy minimizes side effects and increases efficacy by anti-angiogenic effects. The pilot study demonstrated promising responses in all patients. It is not yet known how effective this drug and dosing combination is in treating advanced pancreatic cancer. PURPOSE: This non-randomized phase II trial is studying giving weekly doses of paclitaxel, oxaliplatin, leucovorin and 5-fluorouracil together as second or third-line therapy in treating patient with locally advanced unresectable or metastatic adenocarcinoma of the pancreas following demonstrated progression after first-line gemcitabine.

NCT ID: NCT00259532 Recruiting - Pancreas Cancer Clinical Trials

Three New Methods for Diagnosing Pancreas Cancer

Start date: February 2005
Phase: N/A
Study type: Interventional

The purpose of this project is to evaluate and compare three new methods for diagnosis, staging, operability evaluation and treatment control of pancreas cancer. The investigators use contrast-enhanced ultrasound combined with the gastrointestinal hormones Secretin and Cholecystokinin, which triggers the enzyme production of pancreas. The hormones induce an increased metabolism and thus an increased blood flow through healthy pancreas tissue, however, not in tumor tissue. The investigators hope to be able to use this effect diagnostically. The patients included will also have a 64-slice-CT in order to evaluate, if an increased diagnostic safety can be reached compared to an older CT scanning method. All patients will also be examined for the tumor marker CA 19-9. Further, the investigators will examine if contrast-enhanced ultrasound can contribute with information in treatment control after either surgery or medical treatment.

NCT ID: NCT00197431 Recruiting - Pancreatic Cancer Clinical Trials

Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer

Start date: January 2004
Phase: Phase 2
Study type: Interventional

S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug of 5-fluorouracil (5-FU); 5-chloro-2,4-dihydropyridine (CDHP), which inhibits dihydropyrimidine dehydrogenase (DPD) activity; and potassium oxonate (Oxo), which reduces gastrointestinal toxicity. 5-FU is metabolized by CYP2A6 and DPD. In this study, the researchers investigate the influences of differences in activities of CYP2A6 and DPD on pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes in digestive organ cancer patients treated with S-1.

NCT ID: NCT00178763 Recruiting - Clinical trials for Pancreatic Neoplasms

Hyperthermia With Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer

FR-WB-TT
Start date: September 2003
Phase: Phase 2
Study type: Interventional

Thermal therapy (hyperthermia, or heat) enhances the chemotherapy anti-tumor kill. Thermal therapy by itself also kills cancer cells. Whole-body thermotherapy is a systemic treatment that includes the entire body. By using fever-range whole-body thermal therapy, cancer cells can be treated wherever they are throughout the entire body. In this study, we are testing a combination of fever-range thermal therapy combined with chemotherapy to test: 1) the response of metastatic or advanced pancreas cancer to the combined modality treatment of thermotherapy and selected chemotherapy; 2) whether it helps the body immunity fight the pancreas cancer; and 3) if this treatment is safe for the patient. This study does not offer thermal therapy alone. Any patient with measurable, inoperable or metastatic pancreatic cancer may be treated; however, the they will need to undergo specific medical tests to make sure this treatment would be safe for them. We hypothesize that a combined-modality therapy using fever-range whole-body hyperthermia (FR-WBH; temperature = 40 o C; duration = 6 h), administered in an optimized time/sequence schedule with cisplatin, gemcitabine HCl (gemcitabine), and metronomically administered, low-dose interferon-alpha (IFN-alpha) to patients with inoperable or metastatic pancreas cancer, will, without inducing intolerable toxicity: a.) decrease the pancreatic cancer size; b.) improve quality of life; c.) enhance the immune response against the cancer; d.) increase survival; and e.) allow inoperable pancreatic cancer to be converted to operable disease.

NCT ID: NCT00160836 Recruiting - Cholangiocarcinoma Clinical Trials

Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter

Start date: October 2004
Phase: Phase 1
Study type: Interventional

Introduction In patients with a biliary obstruction, tissue is acquired immediately before drainage during endoscopic retrograde cholangio-pancreatography (ERCP). This is performed by passing a brush inside the bile duct stricture. However, brush cytology has a modest sensitivity (30-57%) for the diagnosis of cancer. A device, called the "G.I.U.M." catheter, allows for the sampling of higher amounts of tissue during ERCP compared to brush cytology. The aim of this study is to compare the diagnostic yield of tissue sampling performed in patients with a suspected malignant biliary stricture using 2 techniques, namely a standard brush catheter and the G.I.U.M.. Protocol design Eligible patients will have tissue sampling performed using both techniques during ERCP, the first technique used being randomly assigned and immediately followed by the other one as well as biliary decompression. All specimens obtained will be subjected to cytopathological examination. After inclusion of the total number of patients, smears will be anonymized and analyzed for diagnosis, cell cellularity and quality. The final clinical diagnosis in each case will be based on cytologic results plus histological examination of biopsy specimens.