Clinical Trials

Gastrointestinal Protocols (colon, rectum, pancreas)

As of July 24, 2012 - 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. CALGB 80405: Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU / Leucovorin with Bevacizumab, or Cetuximab, or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum

This study is being done to evaluate the effects (good and bad) of different regimens of chemotherapy. There are two common combinations of chemotherapy drugs used to treat your type of cancer: One uses 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called “FOLFOX;” the other combination uses 5-FU, leucovorin, and irinotecan, this combination is also called “FOLFIRI.” At the present time, the Food and Drug Administration (FDA) has approved each of these as treatment for colon or rectal cancer.

The FDA has also approved the use of a drug called bevacizumab (or Avastin) in combination with these chemotherapy regimens. Bevacizumab plus either of these chemotherapy regimens is considered the standard of care for most patients.

Cetuximab is approved by the FDA for the treatment of colorectal cancer in patients who have developed progressive cancer following the use of irinotecan. Recent studies, however, have shown that people who have a mutation (an abnormality) in a gene in their tumor tissue called

K-ras do not appear to benefit from treatment with cetuximab or other similar drugs.

The purpose of this study is to determine whether cetuximab plus chemotherapy is better than bevacizumab with chemotherapy in patients who do not have K-ras mutations in their tumor tissue.

3. S0809: Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capectibine & Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)

The purpose of this study is to find out what effects, good and/or bad, capecitabine, gemcitabine and radiation have on you and your cholangiocarcinoma.

4. 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.

5. CALGB 80701: A Randomized Phase II Study of Everolimus Alone vs. Everolimus + Bevacizumab in Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors

The purpose of this study is to test what effects, good and/or bad, two new drugs or drug combinations have on patients with advanced pancreatic neuroendocrine cancer. The two regimens are:

Everolimus plus octreotide or
Everolimus plus bevacizumab plus octreotide

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

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