28 studies in 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 -
Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
Rochester, MN
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Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - Assess the confirmed tumor response in patients with metastatic or unresectable locally advanced adenocarcinoma of the small bowel treated with irinotecan hydrochloride, oxaliplatin, and capecitabine when dosed according to UGT1A1 genotype. Secondary - Assess the toxicity of this regimen in these patients. - Assess, preliminarily, whether celiac disease may affect toxicity and outcome in patients treated with this regimen. - Assess, preliminarily, whether tumor origin (duodenal, jejunal, or ileal) affects response or survival in these patients. OUTLINE: This is a prospective, multicenter study. Patients are assigned to 1 of 3 treatment groups based on UGT1A1 genotype. - Group 1 (6/6 UGT1A1 genotype): Patients receive irinotecan hydrochloride IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 2-15. - Group 2 (6/7 UGT1A1 genotype): Patients receive irinotecan hydrochloride as in group 1. They also receive oxaliplatin and capecitabine as in group 1 but at lower doses. - Group 3 (7/7 UGT1A1 genotype): Patients receive irinotecan hydrochloride, oxaliplatin, and capecitabine as in group 1 but at lower doses. In all groups, treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Blood and serum samples are collected at baseline for UGT1A1 genotyping, celiac disease testing, and research studies, including translational and pharmacologic studies. After the completion of study treatment, patients are followed every 6 weeks for 2 years and then periodically thereafter. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
NCT ID:
NCT00433550IRB Number:
06-006631Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer
Scottsdale and Phoenix, AZ
Rochester, MN
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Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer
Location:
Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - To test the hypothesis that laparoscopic-assisted resection is not inferior to open resection, based on a composite primary endpoint of oncologic factors that are indicative of a safe and feasible surgical resection, in patients with stage IIA, IIIA, or IIIB rectal cancer. Secondary - To compare the patient-related benefit of laparoscopic-assisted resection vs open resection, in terms of blood loss, length of stay, and utilization of pain medication. - To compare the disease-free survival and local pelvic recurrence at 2 years. - To compare the quality of life, sexual function, and bowel and stoma function. OUTLINE: This is a multicenter study. Patients are stratified according to site of primary tumor (high vs middle vs low rectum), registering surgeon, and planned operative procedure (low anterior resection vs abdominal perineal resection). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo open laparotomy and rectal resection. - Arm II: Patients undergo laparoscopic-assisted rectal resection. Quality of life is assessed periodically using EORTC Quality of Life Questionnaires (EORTC QLQ-C30 and -CR38), the Linear Analog Self-Assessment (LASA), the Stoma Quality of Life Scale (SQOLS), and the Mayo Bowel Function Questionnaire (MBFQ). After completion of study treatment, patients are followed periodically for up to 5 years.
NCT ID:
NCT00726622IRB Number:
08-007401Who 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
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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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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Liver Cancer
Rochester, MN
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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Liver Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - To estimate the event-free survival (EFS) in pediatric patients with stage I (non-PFH, non-SCU) and stage II (non-SCU) hepatoblastoma treated with surgical resection followed by 2 courses of cisplatin, fluorouracil, and vincristine (C5V). - To determine the feasibility and toxicity of adding doxorubicin hydrochloride to the chemotherapy regimen of C5V for pediatric patients with intermediate-risk hepatoblastoma. - To estimate the response rate to vincristine and irinotecan hydrochloride in previously untreated pediatric patients with high-risk, metastatic hepatoblastoma. - To determine whether timely (between diagnosis and end of second course of chemotherapy) consultation with a treatment center with surgical expertise in major pediatric liver resection and transplant can be achieved in 70% of patients with potentially unresectable hepatoblastoma. - To foster the collection of tumor tissue and biologic samples to facilitate translational research and to provide data that may aid in risk-adapted approaches for subsequent clinical trials. Secondary - To estimate the EFS of patients with stage I PFH treated with surgery alone. - To determine whether liver transplantation (OLT) can be accomplished after successful referral and completion of 4 courses of initial chemotherapy. - To estimate the 2-year EFS for patients once identified as candidates for possible OLT, the 2-year EFS for patients referred to a transplant center that are resected without OLT, and the 2-year EFS for patients referred to a transplant center who receive OLT. - To register pediatric patients with hepatoblastoma who receive OLT with PLUTO (Pediatric Liver Unresectable Tumor Observatory), an international cooperative registry for pediatric patients transplanted for liver tumors. - To determine if PRETEXT grouping can predict tumor resectability. - To monitor the concordance between institutional assessment of PRETEXT grouping and PRETEXT grouping as performed by expert panel review. - To estimate the proportion of stage IV patients who have surgical resection of metastatic pulmonary lesions. - To determine the proportion and estimate the EFS of patients with potentially poor prognostic factors including AFP < 100 ng/mL at diagnosis, microscopic positive surgical margins, surgical complications, multifocal tumors, microscopic vascular invasion, macrotrabecular histologic subtype, and SCU histologic subtype. OUTLINE: This is a multicenter study. Patients are stratified according to risk (very low vs low vs intermediate vs high). Patients are assigned to 1 of 4 treatment groups according to risk group. - Very low-risk group: Patients undergo surgery and receive no further treatment. - Low-risk group (regimen T): Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV on day 2, and vincristine sulfate IV on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. - Intermediate-risk group (regimen F): Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV on day 2, vincristine sulfate IV on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. - High-risk group (regimen W): Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplantation after course 4 of C5VD followed by 2 courses of adjuvant C5VD. After completion of study therapy, patients who receive chemotherapy are followed up periodically for at least 4 years.
NCT ID:
NCT00980460IRB Number:
09-007413Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer
Rochester, MN
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Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. The proportion of subjects with an adenoma recurrence at the 1-year follow-up colonoscopy exam. This adenoma recurrence rate for difluoromethylornithine (DFMO) (eflornithine) + aspirin will be compared to double placebo to see if there is improvement in the adenoma recurrence rate in this patient population. SECONDARY OBJECTIVES: I. To determine the relative tolerability and safety of the treatment regimens administered for 12 months. II. To determine the effect of the study drugs (aspirin [acetylsalicylic acid] + DFMO) and placebo with respect to proliferation (Ki67 labeling index), apoptosis (caspase-3 expression assay), and drug effect markers (COX-1, -2, polyamines, PGE2) from adenomas, aberrant crypt focus (ACF) and normal-appearing mucosa using pre- and 12-month post-intervention tissue biopsy samples. III. To estimate the percentage change in rectal ACF number, as determined by magnifying colonoscopy in subjects treated for 12 months with placebo or study drugs (aspirin +DFMO) by comparing % change in drug versus placebo arms. IV. To characterize ACF based on three criteria (ACF size [crypt number < 50 or >= 50], crypt morphology characteristics, and histology) of ACF and to correlate such characteristics with the intervention (vs placebo). Also, to evaluate the natural history of ACF over 1-year on placebo. V. To correlate the 12-month measurements of ACF size (# crypts/ACF), number, morphology, and histopathology with the adenoma recurrence data at 12 and 36 months; correlate the 12-month % (and actual) change in ACF size and number with the 12- and 36-month adenoma recurrence rate; and correlate the adenoma recurrence data at 1 year with the adenoma recurrence data at 3 years. TERTIARY OBJECTIVES: I. To explore the effects of the study agents on a focused panel of tissue biomarkers in pre- and post-intervention biopsy samples from recurrent adenomas, rectal ACF, and adjacent normal-appearing mucosa among subjects enrolled in the phase II clinical trial. II. To determine if cleaved capase-3 expression can improve the detection of apoptotic cells by recognizing cellular commitment to apoptosis prior to late nuclear morphologic features and correlate with apoptotic regulatory proteins, histology, and treatment response. III. To determine the effects of aspirin on its biochemical targets COX-1, -2, and prostaglandin E2, and polyamine levels in subjects receiving DFMO. IV. To examine COX-2-dependent genes (i.e., Bcl-2 and DR5) in adenomas and ACF that have been shown to regulate the intrinsic mitochondrial and extrinsic death receptor-mediated apoptotic pathways in vitro and in vivo. V. To perform expression profiling of adenomas or ACF and to relate such date to ACF histology, size/morphology, modulation by chemopreventive agents, and subsequent adenoma recurrence rates. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive acetylsalicylic acid orally (PO) once daily and eflornithine PO twice daily on days 1-28. ARM II: Patients receive placebo PO three times daily on days 1-28. Treatment repeats every 28 days for 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 6, 12, and 36 months.
NCT ID:
NCT00983580IRB Number:
09-001758Who can I contact for additional information about this study?
Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
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Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Jacksonville, FL
Rochester, MN
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Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Location:
Jacksonville, FL Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To determine the response rate and progression-free survival at 6 months in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer. II. To determine the toxicity of the combination of temsirolimus and bevacizumab in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer. SECONDARY OBJECTIVES: I. To collect blood and tumor specimens from all patients entered on the trial for possible future analysis. OUTLINE: Patients receive temsirolimus intravenously (IV) on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. 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 years.
NCT ID:
NCT01010126IRB Number:
08-005230Who can I contact for additional information about this study?
Rochester: Charles Erlichman 507-284-2511
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Jacksonville: Gerardo Colon-Otero 507-538-7623
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Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery
Scottsdale and Phoenix, AZ
Rochester, MN
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Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - To compare disease-free survival of patients with resected stage III colon cancer treated with adjuvant FOLFOX chemotherapy comprising oxaliplatin, fluorouracil, and leucovorin calcium with versus without celecoxib. Secondary - To contribute to an international prospective pooled analysis comparing disease-free survival of patients treated with these regimens. - To compare overall survival at 3 years of patients treated with these regimens. - To contribute to an international prospective pooled analysis comparing disease-free survival of patients treated with 6 versus 12 courses of FOLFOX chemotherapy. - To assess toxicities of celecoxib as maintenance adjuvant therapy in these patients. - To assess differences in cardiovascular-specific events in patients treated with versus without celecoxib. - To evaluate differences in toxicities, particularly cumulative peripheral neuropathy, in patients treated with 6 versus 12 courses of FOLFOX chemotherapy. OUTLINE: This is a multicenter study. Patients are stratified according to number of positive lymph nodes* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs no). Patients are randomized to 1 of 4 treatment arms. NOTE: *Patients with N1c-only disease (i.e., no positive nodes but N1c disease by AJCC 7) should be stratified to 1-3 nodes. - Arm I: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours (FOLFOX) on day 1. Patients also receive oral celecoxib once daily on days 1-14 beginning on day 1 of course 2 of FOLFOX. Courses repeat every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive FOLFOX as in arm I and oral placebo once daily on days 1-14 beginning on day 1 of course 2. Courses repeat every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. - Arm III: Patients receive FOLFOX and celecoxib as in arm I. Courses repeat every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. - Arm IV: Patients receive FOLFOX and placebo as in arm II. Courses repeat every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. In all arms, treatment with celecoxib or placebo continues for 3 years in the absence of disease progression or unacceptable toxicity. Blood and tissue samples maybe collected for biomarker analysis and pharmacogenomic studies. After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for years 2-3, and then annually for 3 years.
NCT ID:
NCT01150045IRB Number:
10-005499Who 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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