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Clinical Trials

Gastrointestinal Protocols (colon, rectum, pancreas)

As of July 8, 2013 - protocols do open and close daily.  
Please check with your physician for additional protocols and/or information.


1. S0713: Phase II Study of Oxaliplatin, Capecitabine, Cetuximab, and RT in Pre-Operative Therapy in Rectal Cancer

The purpose of this study is to find out what effects, good and/or bad, the combination of this chemotherapy (including cetuximab), radiation therapy and surgery has on you and your rectal cancer.

2. RTOG 0848: A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma

The standard treatment for patients with pancreatic cancer that was removed by surgery is to receive the chemotherapy drug gemcitabine. In this study, you will get either gemcitabine alone or gemcitabine combined with erlotinib. Erlotinib is a pill that may help treat cancers by blocking a gene that is important in cancer growth.

3. CALGB 80802: A Phase III Randomized Study of Sorafenib + Doxorubicin vs. Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)

The purpose of this study is to compare the effects (good and bad) of the drug sorafenib with the combination of sorafenib plus doxorubicin on you and your advanced primary liver cancer to find out which is better.

4. RTOG 1010: A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment Of HER2-Overexpressing Esophageal Adenocarcinoma

This study is being done to compare the effects, good and/or bad, of the addition of trastuzumab to standard chemotherapy, radiation, and surgery for patients with HER2 positive esophageal cancer.

5. N0148: A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation vs. Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision

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.

6. NSABP P5: Statin Polyp Prevention Trial in Patients with Resected Colon Cancer

This study will look at the effects, good and/or bad, of the drug rosuvastatin (also called Crestor®). Rosuvastatin is a type of drug called a statin. The U.S. Food and Drug Administration (FDA) and Health Canada have approved rosuvastatin for use in lowering cholesterol. Reports of people who take statins to lower cholesterol suggest that statins may also lower the risk of certain cancers developing, including cancers of the colon or rectum (also called colorectal cancer or CRC). Rosuvastatin is considered to be investigational, which means it is still being tested, for use by people who have colon cancer to prevent adenomatous polyps and new CRC. Adenomatous polyps are a type of polyp that is more likely to become a cancer. In this consent form, adenomatous polyps will be referred to simply as "polyps".

  • The main purpose of this study is to find out whether or not rosuvastatin is able to prevent colon polyps and CRC from occurring in patients who have already had a colon cancer removed by surgery. People who have had colon cancer have a greater than average risk of developing polyps in the colon and rectum that may become CRC in the future. Prevention of polyps may reduce the risk of a new CRC.
  • Another reason for doing this study is to learn about the side effects of rosuvastatin when given to prevent the development of polyps and new CRC.
  • This study will also evaluate the benefits of rosuvastatin in certain groups of patients, for example, patients who take daily aspirin and patients with a family history of colon or rectal polyps or CRC.

7. CALGB 80803: Randomized Phase II Trial Of Pet Scan-Directed Combined Modality Therapy In Esophageal Cancer

The purpose of this trial is to learn if we can improve the outcomes for patients with esophageal cancer by using PET/CT scans to determine whether or not a particular chemotherapy regimen is showing any effect on the tumor. We are trying to learn if PET/CT response can be used as a way to better direct therapy for your tumor.

8. S1115: Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate and MK-2206 vs. mFOLFOX in Patients with Metastatic Pancreatic Cancer after Prior Chemotherapy

The purpose of this study is to find out what effects, good and/or bad, the combination of MK-2206 and AZD6244 hydrogen sulfate or a standard combination of oxaliplatin and fluorouracil (5-FU) called mFOLFOX, has on you and your metastatic pancreatic cancer. MK-2206 and AZD6244 hydrogen sulfate are investigational drugs that have not been approved by the FDA for use in this type of cancer. The combination of MK-2206 and AZD6244 hydrogen sulfate is experimental.

9. RTOG 1010: A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment Of HER2-Overexpressing Esophageal Adenocarcinoma

A standard treatment for esophageal adenocarcinoma is treatment with radiation therapy and the chemotherapy drugs paclitaxel and carboplatin. Afterwards surgery is done to remove the cancer by removing the esophagus. This study will test whether the addition of the drug trastuzumab to standard treatment with paclitaxel, carboplatin, and surgery can help prevent your cancer from growing back.

Trastuzumab is a drug that can only be effective in cancers that are HER2 positive. HER2 positive cancer means that the cancer has increased amounts of either HER2 genes or HER2 protein. (Genes are inside cells and make proteins.) Trastuzumab attaches to the HER2 protein. In patients with HER2 positive breast cancer, trastuzumab is proven to reduce cancer from growing back. However, the use of trastuzumab for esophageal cancer is experimental.

For more information on these protocols or any other research, please contact your physician or our clinical research coordinator, Jessica Gerlach, CCRP at 845-333-1133

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Middletown, NY 10940

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