Clinical Trials

Cancer Type: Colorectal


2010-383

CALGB C80702: A Phase III Trial of 6 versus 12 Treatments of Adjuvant Folfox plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer.

This study is for patients who have cancer of the colon that has been surgically removed, but has spread to lymph nodes (Stage III colon cancer). This study is being done to evaluate the effects of different chemotherapy treatments. One of the common combinations of chemotherapy drugs used to treat colon cancer includes 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called FOLFOX. FOLFOX is a standard treatment used to prevent colon cancer from coming back (recurrence).

In this study we will evaluate the effects of an oral drug called celecoxib when given in combination with FOLFOX chemotherapy. The addition of celecoxib to FOLFOX is considered investigational. One of the purposes of this study is to determine if giving patients 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 for this stage of colon cancer is 12 treatments with FOLFOX. That was the number of treatments tested in previous research studies. However, it is not known if fewer treatments would be as helpful in preventing colon cancer from coming back.

Hospitals Offering This Trial: Lombardi/MedStar Georgetown University Hospital; Franklin Square Hospital Center; Washington Hospital Center

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2010-084

A Pilot Trial of GI-4000 plus Bevacizumab and either FOLFOX or FOLFIRI in Patients with Newly Diagnosed Ras Mutant Positive Metastatic Colorectal Cancer.

People are being asked to participate in this study who have newly diagnosed metastatic colorecal cancer, have completed first line therapy with Bevacizumab plus FOLFOX or FOLFIRI or are getting ready to start first-line therapy with these drugs, and the tumor(s) has a cancer signal (known as a mutation) which is contained in the GI-4000 product. The purpose of this study is to test the safety of GI-4000 and see what effects it has against cancer over time. This study is also being done to measure the immune response to GI-4000. Study drug will be given in addition to standard of care which is a standard therapy given to patients with colon cancer.

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2010-360

A prospective study for the assessment of recurrence risk in stage II colon cancer patients using ColoPrint.

People are being asked to participate in this study that have colon cancer and are going to have the tumor removed surgically. A small piece of tumor that is routinely removed during surgery will be sent to Agendia (located in the Netherlands) for the analysis of its gene expression. Enough of the tumor tissue will remain at the hospital for any additional tests the subjects may need to have in the future.

In order to determine the best way to treat the tumor, the physician defines the risk of recurrence of the tumor based on various clinical and pathological factors (for example the stage of the disease). However, it remains difficult to predict long-term outcome and the best way of treatment for any individual.

The purpose of this study is to test the use of a new diagnostic test, called ColoPrint, in a clinical setting. The test determines the activity of the genes in tumor tissue. Subsequently, the gene activity of a tumor is compared to a large database of gene activities in tumor tissue from patients with known disease outcomes. This will identify patients with a higher risk of recurrent disease (who would most likely benefit from additional chemotherapy) and patients with a low risk (who could be spared unnecessary treatment). The diagnostic procedure is called genomic profiling.

This research is being done because it is unknown if ColoPrint will be an effective test for determining the likeliness of tumor recurrence.

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Contact : Nina Gabelia
Email: NG225@georgetown.edu
Phone: 202-687-1265

Pro-063

A Phase II Study of Dovitinib as Maintenance and Adjuvant Therapy in Patients with Colorectal and Pancreas Cancers.

This study is for patients with stage 4 colon cancer who have had initial chemotherapy or had surgery to remove metastases and patients with pancreas cancer, which has been surgically removed and are receiving adjuvant chemotherapy or is locally advanced and have already received chemotherapy and radiation.

The purpose of this study is to determine the effects of oral dovitinib in patients with advanced stage colorectal and pancreas. Dovitinib will be taken by mouth for 5 days out of every week for up to 2 years.

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2013-0596

Title: A Phase I/II Study of Once or Twice Weekly IMMU-130 (hMN-14–SN38) Antibody-Drug Conjugate) in Patients with Colorectal Cancer.

Description: This study is for patients with colorectal cancer. Standard treatments for colorectal cancer may use forms of chemotherapy. In some cases, external radiation therapy may be used as well. These treatments may slow the cancer for some patients, but the cancer will continue to worsen for most patients. The study doctor is researching a new therapy product called IMMU-130. IMMU-130 is composed of a drug attached to an antibody. The drug is the active ingredient in irinotecan which is a common chemotherapy drug used for colorectal cancer. Antibodies are proteins normally made by the immune system. They bind to substances that don’t belong in the body to prevent harm to the body. The antibody in this study was designed to bind to a marker located on colorectal cancer tumors. The antibody was originally made from mouse proteins, but was changed in the laboratory to be more like human antibodies. This study will investigate how IMMU-130 acts for the treatment of colorectal cancer. The study is mainly being done to see if IMMU-130 is safe.

The purpose of this study is to test the safety of IMMU-130 at different dose levels. We want to find out what effects, good and/or bad, it has on the subject and their advanced colorectal cancer.

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Contact Information

Karen Vogel
Email: KD252@georgetown.edu
Phone: 202-687-6974