View clinical trials related to Pancreatic Cancer.
Filter by:This phase Ib study includes two phases: dose escalation phase and safety expansion phase. During the dose escalation phase, successive cohorts of eligible patients (minimum 3 and maximum 6 evaluable patients per cohort) will receive increasing oral doses of LDE225 administered on a continuous once daily (QD) dose in combination of gemcitabine. This phase of the study will determine the maximum tolerated dose (MTD) and/ or recommended dose for expansion (RDE) of LDE225 administered in combination with gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma patients. During the safety expansion phase, once the MTD of LDE225 is established, additional patients will be enrolled and treated at the MTD of LDE225 in combination with gemcitabine in order to further evaluate its safety, tolerability and explore the potential efficacy of the combined treatments on the patients in locally advanced or metastatic pancreatic adenocarcinoma.
LDE225 is a new medicine that blocks the Hedgehog (Hh) pathway. The Hh pathway is a cascade of molecular events that control cell growth and have been linked with the development of many human cancers, including pancreatic cancer. Information from research studies suggests that LDE225 in combination with FOLFIRINOX may help to stop the growth of cancer cells. In this research study, the investigators are looking to determine the maximum dose of LDE225 in combination that can be given safely to patients with locally advanced or metastatic pancreatic cancer.
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as ganitumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective with or without ganitumab in treating patients with pancreatic cancer. PURPOSE: This phase I/II trial is studying the best dose of combination chemotherapy and ganitumab and how well combination chemotherapy with or without ganitumab works in treating patients with previously untreated metastatic pancreatic cancer.
This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.
This study will evaluate the role of Gemcitabine and Abraxane in the treatment of resectable and borderline-resectable pancreatic cancer by giving the chemotherapy before surgery.
Primary Objectives To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with cisplatin in subjects with metastatic pancreatic cancer based on the progression-free survival (PFS) rate at 6 month. Secondary Objectives - To assess safety and characterize toxicities of the combination of GTX with cisplatin in subjects with metastatic pancreatic cancer. - To estimate disease control rate (DCR), PFS, and overall survival (OS). - To estimate a PFS rate of an expansion cohort testing an alternative schedule. Study Design This study is a single arm phase II study to assess the efficacy of GTX with cisplatin in subjects with metastatic pancreatic cancer. Approximately 38 evaluable subjects will be enrolled, 28 in the initial cohort and 10 in the expansion cohort The study will have a safety run-in phase consisting of 6 subjects. To ensure that the combination is safe, the first six subjects will be treated at DL1 and observed for limiting toxicity for the first 2 cycles before continuation with further accrual. After the safety run-in, the study will be continuously monitored for adverse events. The primary endpoint will be the PFS rate at 6 month, which is defined as the proportion of subjects alive, free of disease progression at 6 months. The treatment regimen would be considered of insufficient activity for further study in this population if PFS rate at 6 months is 50% or less, and the minimum required level of efficacy that would warrant further study with the proposed regimen is a 75% PFS rate at 6 months. The study design includes interim monitoring for futility using a predictive probability approach. We will stop the study early if given the information at the interim analysis, it is unlikely that the PFS rate at 6 months will be greater than 50% if the study continues to the end.
Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.
The Principal Investigator believes that Vitamin E δ-Tocotrienol will slow the progression of pancreatic cancer cells. Therefore, the investigators must determine the safety and tolerability of Vitamin E δ-Tocotrienol in healthy participants before administering to cancer patients. The investigators will do this by giving participants a dose of up to1600 mg twice a day, not to exceed 3200 mg total for 14 consecutive days.
This is a Phase 1, open-label, non-randomized, dose-finding, study of Vitamin E δ-Tocotrienol in subjects with resectable pancreatic tumors.
Background: - Gastrointestinal cancers are among the most commonly diagnosed cancers in the United States. - There are currently no tests to predict how patients with gastrointestinal cancers will respond to radiation therapy or which patients may develop side effects from treatment. - Studies on tumor cells in the stool, urine, or blood from patients may provide valuable information that can be used to develop tests to determine which patients may need more or less aggressive therapy. - Studies of other substances in the stool, urine, or blood from patients may provide valuable information that can be used to develop tests to determine which patients are likely to develop side effects from radiation treatments. Objectives: - To collect blood, urine and stool specimens from patients with gastrointestinal cancers who will undergo radiation therapy. - To study hormone and protein changes in these blood, urine and stool specimens before, during and after radiation treatment in order to develop a way to predict how gastrointestinal cancers will respond to radiation therapy and if patients with these cancers will develop side effects from radiation treatment. Eligibility: -Patients 18 years of age and older with cancer of the gastrointestinal tract (esophagus, stomach, pancreas, rectum) who plan to receive radiotherapy to the site of the cancer on an National Cancer Institute (NCI) protocol Design: Participants undergo the following procedures: - Tumor biopsy: Before any treatment or at the time of surgery if it is the first treatment - Urine collection: Before, during, and after treatment and at follow-up visits. - Stool collection: Before, during, and after treatment and at follow-up visits. - Blood collection: Before, during, and after treatment and at follow-up visits. - Intestinal permeability assessment: Before any treatment, before radiation (if radiation is not the first treatment), 1 month after radiation is completed, and 3 months after radiation is completed. This test determines how the patients intestines are working to absorb sugar and may provide information about side effects from radiation treatments. Patients fast after midnight, then drink a small glass of sugars, and then do a 6-hour urine collection.