13 studies in Pancreatic Cancer
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Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
Jacksonville, FL
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Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
Location:
Jacksonville, FLTrial status:
Open for EnrollmentWhy is this study being done?
The overall goal of this study is to test a technique that in the future may allow endoscopic detection of pancreatic neoplasia. The study is a single group, prospective, open label pilot study designed to assess the feasibility and efficacy of 4D-ELF in detecting EIBS in peri-ampullary duodenal mucosa in pancreatic cancer patients compared to control patients. The expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up is complete after the initial evaluation.
NCT ID:
NCT01015820IRB Number:
09-002596 -
AZD0530 in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Scottsdale and Phoenix, AZ
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AZD0530 in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES:
Primary
- To determine the 6-month survival of biomarker-positive patients with previously treated metastatic pancreatic cancer receiving AZD0530.
- To determine the adverse events of this drug in these patients.
Secondary
- To evaluate the response rate in patients treated with this drug.
- To evaluate the overall survival of patients treated with this drug.
- To explore the pharmacodynamic effects of AZD0530 with optional tumor biopsies, pharmacokinetic studies, and PET scans in a subset of patients.
OUTLINE: This is a multicenter study.
Patients receive oral AZD0530 once daily on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also complete a medication diary.
Periodically, tumor biopsies for pharmacodynamic studies and limited pharmacokinetic blood sampling, plus pharmacogenomic studies are conducted.
After completion of study treatment, patients are followed up for 2 years.NCT ID:
NCT00735917IRB Number:
07-002414Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders
Jacksonville, FL
Scottsdale and Phoenix, AZ
Rochester, MN
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Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - To collect clinical data and family histories and blood and/or tissue samples from patients diagnosed with pancreatic diseases, including pancreatic cancer, for use in future studies. - To collect information regarding food preparation and intake in these patients. Secondary - To make available to researchers medical data and biospecimens to enable them to develop better ways to screen people at risk for pancreatic conditions, including pancreatic cancer. - To investigate genes or substances that increase susceptibility of developing pancreatic conditions. - To find agents that may help prevent, treat, or cure these conditions. - To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers. OUTLINE: This is a multicenter study. Patients complete two 1-hour surveys assessing health, clinical and family history of pancreatic conditions including cancer, and food preparation and intake. Patients also complete a 15- to 30-minute follow up survey at 6 months and 1 year to assess health, health practices, and family history. A review of the patient's medical information is obtained from the medical record. Blood samples are collected for future research studies. Oral cells and stool samples may also be collected for future studies.
NCT ID:
NCT00830557IRB Number:
354-06 356-06Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma
Rochester, MN
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Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: - To collect clinical history, family history, and blood and/or tissue samples from family members of patients diagnosed with pancreatic diseases, pancreatic cancer, or melanoma. - To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers. OUTLINE: Study participants undergo collection of blood and/or tissue samples as well as survey data for inclusion in a familial data and tissue registry. Participants complete two baseline surveys regarding their personal, family, health, and environmental exposure histories and regarding their opinions on cancer and cancer screening. Patients also complete a follow-up survey at 1 year and undergo review of their medical records.
NCT ID:
NCT00835133IRB Number:
355-06Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed By the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed By Surgery
Rochester, MN
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Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed By the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed By Surgery
Location:
Jacksonville, FL Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To determine whether the addition of erlotinib hydrochloride to adjuvant chemotherapy comprising gemcitabine hydrochloride improves survival as compared to gemcitabine hydrochloride alone following R0 or R1 resection in patients with pancreatic adenocarcinoma. II. To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine hydrochloride-based chemotherapy further enhances survival of patients who have no evidence of progressive disease after 5 courses of gemcitabine hydrochloride-based chemotherapy. SECONDARY OBJECTIVES: I. To evaluate the disease-free survival of patients who are disease-free after 5 courses of adjuvant gemcitabine hydrochloride-based chemotherapy followed by fluoropyrimidine-based chemoradiotherapy. II. To evaluate the disease-free survival of patients treated with adjuvant gemcitabine hydrochloride-based chemotherapy with vs without erlotinib hydrochloride. III. To evaluate the disease-free and overall survival of patients stratified by wild-type and K-Ras status treated with adjuvant gemcitabine hydrochloride-based chemotherapy with vs without erlotinib hydrochloride. IV. To evaluate adverse events associated with adjuvant gemcitabine hydrochloride-based chemotherapy with vs without erlotinib hydrochloride in these patients. V. To evaluate adverse events associated with adjuvant gemcitabine hydrochloride-based chemotherapy with vs without fluoropyrimidine-based chemoradiotherapy in patients who are disease-free after adjuvant gemcitabine hydrochloride-based chemotherapy. VI. To evaluate preoperative cross-sectional imaging of primary adenocarcinoma of the head of the pancreas in order to determine the frequency with which objective criteria of resectability are present. VII. To determine the predictive roles of K-Ras mutations and epithelial to mesenchymal transition phenotype in response to epidermal growth factor receptor (EGFR) tyrosine kinase inhibition in early-stage pancreatic cancer. VIII. To determine the frequency of EGFR-activated pathway and its influence on outcome. IX. To determine the association between developmental molecular markers and outcome. X. To determine the phenotype and genotype of tumors in patients with recurrence after resection. XI. To determine if low baseline fatigue, as measured by the FACIT-Fatigue, predicts survival. XII. To explore correlations between baseline fatigue, as measured by PROMIS, and survival. OUTLINE: This is a multicenter study. Patients are stratified according to nodal status (involved vs uninvolved), CA19-9 result (≤ 90 IU/L vs 91-180 IU/L), and surgical margins (positive [R1] vs negative [R0]). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive gemcitabine hydrochloride as in arm I and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression after treatment in arm I or II are then stratified according to their first randomization treatment arm (arm I vs arm II) and randomized to 1 of 2 additional treatment arms (arm III or IV). ARM III: Patients receive 1 course of the same treatment that they receive in arm I or II. ARM IV: Patients receive 1 course of the same treatment that they receive in arm I or II. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either oral capecitabine twice daily 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. After completion of study, patients are followed up periodically.
NCT ID:
NCT01013649IRB Number:
10-005091Who can I contact for additional information about this study?
Rochester: Michael G. Haddock 507-538-7623
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Jacksonville: Michael G. Haddock 507-538-7623
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Immunotherapy Study for Surgically Resected Pancreatic Cancer
Jacksonville, FL
Rochester, MN
View Summary
Immunotherapy Study for Surgically Resected Pancreatic Cancer
Location:
Jacksonville, FL Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most patients diagnosed with pancreatic cancer continue to die from the rapid progression of their disease. The primary reason for this is that the disease is typically without symptoms until significant local and/or distant spread has occurred and is often beyond the chance for cure at the time of the diagnosis. The lack of any treatment to significantly increase long term survival rates is reflected by the poor outcomes associated with this disease, specifically time to disease progression and overall survival. These disappointing facts typically shape discussions of treatment options for patients with this disease. However, another important part of the body is now being looked at as a target for therapy against this disease -- the immune system. Scientists have clearly shown that pancreatic tumor cells produce a number of defective proteins, or express normal proteins in highly uncharacteristic ways, as part of this cancer. In some cancers, these abnormalities can cause an immune response to the cancer cells much in the way one responds to infected tissue. In progressive cancers however, the immune system fails to identify or respond to these abnormalities and the cancer cells are not attacked or destroyed for reasons not yet fully understood. This clinical trial proposes a new way to stimulate the immune system to recognize the abnormal components found in pancreatic cancer cells and to stimulate an immune response that destroys or blocks the growth of the cancer. This new method of treatment helps the immune system of pancreatic cancer patients to "identify" the cancerous tissue so that it can be eliminated from the body. As an example, most people are aware that patients with certain diseases may require an organ transplant to replace a damaged kidney or heart. After receiving their transplant these patients receive special drugs because they are at great danger of having an immune response that destroys or "rejects" the transplanted organ. This "rejection" occurs when their immune system responds to differences between the cells of the transplanted organ and their own immune system by attacking the foreign tissue in the same way as it would attack infected tissue. When the differences between foreign tissues and the patient's body are even larger, perhaps like differences between organs from pigs and the immune system cells of humans, the rejection is very rapid, highly destructive and the immunity it generates is long lasting. This is called hyperacute rejection and the medicine used to immunize patients in this protocol tries to harness this response to teach a patient's immune system to fight their pancreatic cancer just as the body would learn to reject a transplanted organ from an animal. To do this, the investigators have placed a mouse gene into human pancreatic cancer cells so that the immune system will easily recognize them as foreign, stimulating the patient immune system to attack the vaccine cells just as they would any other animal cells. As part of the process of destroying the immunotherapy cells, the patient immune system is stimulated to identify as many differences from normal human as possible. This extra stimulation is thought to encourage immune responses against the pancreatic cancer in the patient based on shared abnormalities of pancreatic cancer vaccine cells and the patient's pancreatic cancer cells. In this experimental therapy, patients are given injections of an immunotherapy consisting of two types of cancer cells that the investigators have modified to make them more easily recognized and attacked by the immune system. The investigators propose to test this new treatment in patients with pancreatic cancer who have undergone tumor removal surgery but remain at extremely high risk of disease progression to demonstrate that treatment with the immunotherapy increases the time until the tumor recurs or increases overall survival when given in combination with the current standard of care therapy for this disease. For more information, please see our study specific website: www.pancreaticcancer-clinicaltrials.com
NCT ID:
NCT01072981IRB Number:
10-005983Who can I contact for additional information about this study?
Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
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Jacksonville: Mayo Clinic Clinical Trials Office 507-538-7623
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Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery
Jacksonville, FL
Scottsdale and Phoenix, AZ
Rochester, MN
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Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of the combination of vismodegib and sirolimus in unresectable solid tumors. (Cohort I) SECONDARY OBJECTIVES: I. To describe the adverse event profile associated with this treatment combination. II. To describe the tumor responses to treatment combination. CORRELATIVE OBJECTIVES: I. To assess the effect of the sirolimus and vismodegib combination on selected biomarkers in tumor biopsies of patients with metastatic pancreatic cancer. II. To assess the effect of the combination of vismodegib and sirolimus on fludeoxyglucose F 18 (F18-FDG) positron emission tomography (PET) or PET/computed tomography (CT) imaging in Cohort II (MTD) patients with metastatic pancreatic cancer. III. To study the association of clinical (toxicity and/or tumor response or activity) with the biologic (pharmacodynamic) results obtained by examining tissue biopsies and PET or PET/CT imaging from the same patients. OUTLINE: This is a dose-escalation study of sirolimus. Patients receive sirolimus orally (PO) once daily (QD) and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 months.
NCT ID:
NCT01537107IRB Number:
11-005517Who can I contact for additional information about this study?
Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
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Scottsdale: Mayo Clinic Clinical Trials Office 507-538-7623
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Pancreatic Juice Diagnosis From Duodenum
Jacksonville, FL
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Pancreatic Juice Diagnosis From Duodenum
Location:
Jacksonville, FLTrial status:
Open for EnrollmentWhy is this study being done?
Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival rate of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs are currently diagnosed at more advanced non-resectable stages since minimally invasive technique which is capable of screening early-stage PC does not exist. Serum CA19-9 is not recommended as a screening technique because of its low sensitivity and specificity. Imaging modalities such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening tools due to their high cost, discomfort and complications. Therefore, there is a strong demand for a screening tool with high sensitivity and specificity which is highly acceptable for the patient. The investigators would like to standardize the detection method of pancreatic cancer that uses the duodenal juice as an optional endoscopic diagnosis. It's a very useful chance to collect pancreatic juice from duodenum, it is called "duodenal juice" ,if we collect them without additional invasion. The investigators would like to collect duodenal juice during undergoing upper gastrointestinal endoscopy and analyze the pancreatic tumor markers in duodenal juice. A definite diagnosis of the patient is made with histology, cytology or imaging diagnosis and the result of each definite diagnosis is correlated to the each marker analyzing result of duodenal juice. Therefore this study can be positioned as a feasibility study to confirm clinical performance.
NCT ID:
NCT01699698Who can I contact for additional information about this study?
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Jacksonville: Massimo Raimondo, M.D.
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A Study of DMOT4039A in Patients With Unresectable Pancreatic or Platinum-Resistant Ovarian Cancer
Jacksonville, FL
Scottsdale and Phoenix, AZ
Rochester, MN
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A Study of DMOT4039A in Patients With Unresectable Pancreatic or Platinum-Resistant Ovarian Cancer
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
This multicenter, open-label, dose-escalating study will assess the safety and efficacy of DMOT4039A in patients with unresectable pancreatic or platinum-resistant ovarian cancer. Cohorts of patients will receive multiple ascending intravenous doses of DMOT4039A. Anticipated time on study treatment is up to 1 year or until disease progression occurs.
NCT ID:
NCT01469793IRB Number:
11-004436 -
Safety and Efficacy Study of PRI-724 Plus Gemcitabine in Subjects With Advanced or Metastatic Pancreatic Adenocarcinoma
Jacksonville, FL
Scottsdale and Phoenix, AZ
Rochester, MN
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Safety and Efficacy Study of PRI-724 Plus Gemcitabine in Subjects With Advanced or Metastatic Pancreatic Adenocarcinoma
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRI-724 is a small molecule antagonist that binds to the co-activator CBP thereby specifically inhibiting the subset of Wnt/β-catenin-driven genes that are up-regulated in cancer cells. PRI-724 is being developed as a potential antineoplastic agent. Purpose: To determine the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of sequential escalating doses per cohort of PRI-724 administered in combination with gemcitabine to patients with adenocarcinoma of the pancreas that is locally advanced, metastatic, or otherwise inoperable, who are candidates for second-line therapy after failing first-line therapy with FOLFIRINOX (i.e., folinic acid [leucovorin], fluorouracil, irinotecan, oxaliplatin) - PRI-724: 320, 640, 905 mg/m2/day, continuous intravenous (CIV) infusion over 24 h, daily × 7 days, 1 week on with 1 week recovery × 2 (4 weeks equals 1 cycle) - Gemcitabine: 1000 mg/m2 IV over 30 minutes; 3 weeks on with 1 week recovery (4 weeks equals 1 cycle) Patients with documented, measurable or evaluable adenocarcinoma of the pancreas that is locally advanced, metastatic, or otherwise inoperable, who are candidates for second-line therapy after failing first-line therapy with FOLFIRINOX, will be entered into this phase 1b, multicenter, open-label, non-randomized, dose-escalation per cohort study. The trial is designed to evaluate the safety, tolerability, DLT(s), and MTD of escalating doses of PRI-724, a CBP/ β- catenin inhibitor, when administered in combination with a standard dose of gemcitabine. Correlative studies include characterization of the PK profiles of PRI-724 and gemcitabine, evaluation of the utility of potential PD markers of PRI-724 activity, as well as preliminary assessment of the antineoplastic activity of PRI-724 plus gemcitabine in this patient population.
NCT ID:
NCT01764477IRB Number:
12-006767Who can I contact for additional information about this study?
Rochester: Robert R McWilliams, M.D. 507-538-7623
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Scottsdale: Donald W Northfelt, M.D. 507-538-7623
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