Colorectal Cancer

Clinical Trials


Title: 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.

Description: 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.

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

Description: 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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Title: TO-TAS-102-401: An Open-Label, Expanded Access Study of TAS-102 in Patients with Metastatic Colorectal Cancer Refractory to or Failing Standard Chemotherapy

Description: This study is for patients with colorectal cancer that has progressed or not responded to standard therapy.
All subjects will take the study drug TAS-102 as a pill twice a day

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Title: N1048: A Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer

Description: The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely since 2002 to treat patients with advanced colorectal cancer.

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Title: Regorafenib in Metastatic Colorectal Cancer: An Exploratory Biomarker Study

Description: This study is being done to identify signals or proteins that may help health care providers determine if a patient will benefit from regorafenib treatment. Such signals are called biomarkers. Biomarkers could be proteins or genetic mutations in the tumor or the blood that may predict if a patient would benefit from a particular treatment. Regorafenib is approved by the FDA for treatment of patients with metastatic colorectal cancer. Some patients experience a clinical benefit from regorafenib while others don’t. Doctors therefore designed this study to help identify biomarkers that will help them identify patients that will benefit clinically from regorafenib. Such a finding would spare patients who are not predicted to respond to regorafenib and the side effects. It will also possibly identify groups of patients that will experience a significant benefit from it.

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Title: A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination With Regorafenib in Subjects With Relapsed or Refractory Metastatic Colorectal Cancer

Description: Study of ruxolitinib (or placebo) in combination with regorafenib in patients who have colorectal cancer that has returned or not improved with treatment. Ruxolitinib will be taken by mouth twice a day for 28 days in each 28 day cycle and regorafenib will be taken by mouth the first 21 days of each cycle. Subjects will receive either ruxolitinib & regorafenib or placebo (pill with no active substance) & regorafenib. Participants will be seen regularly in the office for disease follow up, physical exam, bloodwork, etc. A safety follow up visit will ocur about 30 days after the last dose of study treatment and long term follow up will be conducted via phone every 6 -12 weeks thereafter.

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Title: ECOG E7208: A Randomized Phase II Study of Irinotecan and Cetuximab with or Without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-Type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy

Description: This study is for patients with colon or rectal cancer that has spread to other organs or has come back locally with the first choice of treatment and the tumor is now progressing while being treated with standard first-line therapy.

The purpose of this study is to determine what effects the study drug ramucirumab may have and to determine whether it is safe and effective for patients to receive in this setting. Irinotecan and cetuximab are standard treatments for patients who have metastatic colon or rectal cancer, who have already received one previous chemotherapy that is no longer working, and do now have a specific type of mutation (alteration) of the K-ras gene in their tumor. It is unknown if adding ramucirumab to standard second line therapy for colorectal cancer is beneficial. Subjects in this study will be randomized (like the flip of a coin) to receive either the chemotherapy with the study drug or the chemotherapy alone, but will not get both. All the drugs used in this study are given as an IV infusion (through a needle in a vein).

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Title: SWOG S0820: A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer, Phase III- Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)

Description: This study is for patients with a history of colon cancer that has been treated with surgery alone or in combination with chemotherapy.

Colorectal adenomas are tiny growths in the colon that may eventually lead to cancer. The purpose of this study is to determine if eflornithine and sulindac, taken alone or in combination, can decrease the risk of high-grade adenomas or second primary colorectal cancers in patients who have been treated for Stage 0, I, II, or III colon cancer. (“Second primary colorectal cancer” means a new colorectal cancer developing within the colorectum).

The study drugs eflornithine and sulindac are tablets which are taken orally. Subjects on this study will be randomly assigned (like the flip of a coin) to receive either one of the drugs, both of the drugs or placebo (a look alike pill that does not contain active medicine) for three years. 

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