A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer (GIANT)

Date Added
October 8th, 2020
PRO Number
Pro00104741
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal, Pancreas
Summary

This study is for patients over 70 with metastatic pancreatic cancer. We are doing this study because we want to find out what the best approach to lengthen the lives of "vulnerable" patients over the age of 70 with mPCA is.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

DULOXETINE TO PREVENT OXALIPLATIN-INDUCED CHEMOTHERAPY-INDUCED PERIPHERAL NEUROPATHY: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II TO PHASE III STUDY

Date Added
July 6th, 2020
PRO Number
Pro00101249
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal
Summary

This study is for patients receiving oxaliplatin for their cancer treatment. The study is being done to see if duloxetine (either 30 mg or 60 mg) prevents numbness, tingling, and/or pain caused by your cancer treatment with oxaliplatin. The study is being done to see if duloxetine can prevent OIPN (oxaliplatin-induced peripheral neuropathy).

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

RANDOMIZED DOUBLE-BLIND PHASE III TRIAL OF VITAMIN D3 SUPPLEMENTATION IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC COLORECTAL CANCER (SOLARIS)

Date Added
February 4th, 2020
PRO Number
Pro00096338
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with previously untreated metastatic colorectal cancer. The purpose of the study is to see if adding a new drug to the usual combination of drugs can lower the chance of the colorectal cancer growing or spreading.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)

Date Added
January 13th, 2020
PRO Number
Pro00096360
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with colon cancer. The purpose is to determine whether to recommend chemotherapy of no further treatment after surgery for an early stage colon cancer, by taking a blood sample and testing for the presences of circulation tumor DNA (ctDNA)?

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy

Date Added
December 9th, 2019
PRO Number
Pro00091697
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with differentiated thyroid cancer (DTC). The investigational drug used in this study is cabozantinib. The purpose of this study is to evaluate the effect of cabozantinib compared with a placebo in treating patients whose disease has progressed after receiving prior treatment with drugs that inhibit growth of tumor blood vessel (VEGFR-targeted therapy) for their thyroid cancer. Participants can expect to be on this study for about a year including 9 months of treatment, a follow-up visit 4 weeks after treatment and 3 months of follow up.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) plus Platinum and Fluoropyrimidine Versus Placebo plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Date Added
October 7th, 2019
PRO Number
Pro00090649
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

This is a research study to compare the effects and safety, of tislelizumab plus chemotherapy to placebo (an inactive substance) plus chemotherapy on you and your Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (GC/GEJ) to find out the most effective treatment. The study will take place over 3 years 4 months and will include about 17-18 office -visits to the study doctor.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clincal-trials@musc.edu

A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination with Atezolizumab versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy

Date Added
September 23rd, 2019
PRO Number
Pro00091128
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to find out if cabozantinib in combination with atezolizumab is effective in treating liver cancer compared to sorafenib alone in people who have not received prior treatment. Subjects are being asked to take part in this clinical research study because they have hepatocellular carcinoma (liver cancer) that has not been previously treated for advanced disease.It is estimated that subjects will take study drug(s) for this study for approximately 1 to 6 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clincial-trials@musc.edu

A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer

Date Added
September 26th, 2018
PRO Number
Pro00082302
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal
Summary

This study is for patients who have anal cancer that has a high likelihood of returning. The purpose of this study is to find if adding the study drug, nivolumab (also known as OPDIVO®), after standard chemotherapy {(mitomycin-C and 5-fluorouracil (5-FU) or capecitabine) or 5-FU and cisplatin} and radiation will prevent the anal cancer from returning.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of CDX-3379 in Combination with Cetuximab in Patients with Advanced Head and Neck Squamous Cell Carcinoma

Date Added
June 12th, 2018
PRO Number
Pro00076144
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to see whether an investigational drug called CDX-3379 combined with cetuximab, a monoclonal antibody that targets a protein called EGFR, will shrink tumors for subjects with head and neck squamous cell carcinoma (HNSCC). This study is for patients who have been diagnosed with HNSCC and who have previously received cetuximab but who have since experienced progression. Both the investigational drug, CDX-3379, and cetuximab are administered intravenously (into a vein). Subjects can expect to participate in the study for 2 years or longer.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A PHASE III TRIAL OF 6 VERSUS 12 TREATMENTS OF ADJUVANT FOLFOX PLUS CELECOXIB OR PLACEBO FOR PATIENTS WITH RESECTED STAGE III COLON CANCER

Date Added
April 30th, 2013
PRO Number
Pro00024065
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Men's Health, Women's Health
Summary

This study is for subjects who have cancer of the colon, which has been surgically removed, but has spread to lymph nodes. This study is being done to evaluate the effects (good and bad) of different chemotherapy treatments. One of the common combinations of chemotherapy drugs used to treat this type of cancer includes 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called "FOLFOX". The Food and Drug Administration (FDA) has approved each of these drugs as treatment for colon cancer. FOLFOX is a standard treatment used to prevent colon cancer from coming back (recurrence).
In this study, researchers will evaluate the effects (good and bad) of an oral drug called celecoxib when given in combination with FOLFOX chemotherapy. Celecoxib is approved by the FDA to treat arthritis and some other painful conditions. The addition of celecoxib to FOLFOX chemotherapy is considered investigational. One of the purposes of this study is to determine if giving subjects celecoxib (by mouth) and chemotherapy decreases the risk of colon cancer recurrence.
This study will also look at whether receiving FOLFOX chemotherapy for 6 treatments (12 weeks) is as good as 12 treatments (24 weeks) in preventing recurrence of colon cancer. Currently, the standard of care is 12 treatments with FOLFOX. In this trial, researchers will explore whether 6 treatments are as effective as 12 treatments and whether side effects can be reduced with fewer treatments. It expected that subjects will be enrolled in this trial for up to 3 years.

Institution
MUSC
Recruitment Contact
Andie Adelman
843-792-1507
adelman@musc.edu



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