Steven R. Alberts, M.D., M.P.H.

Closed for Enrollment

• A Phase 1 Pharmacokinetic and Safety Study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) Alone and in Combination With Carboplatin in Subjects With Advanced Solid Malignancies Rochester, Minn., Scottsdale/Phoenix, Ariz.

  This is a phase I study of PICN alone and in combination with carboplatin and consisting of 2 sequential parts.

  Part A will characterize the pharmacokinetic profile of PICN at 3 dose levels administered as 30-min infusion to separate groups of 3 subjects with advanced solid malignancy.

  Part B will start upon completion of Part A and will use the standard '3+3' dose-escalation design to determine the MTD and recommend phase II dose of PICN in combination with carboplatin.

• A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib (CELESTIAL) Rochester, Minn.

  The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.

• A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy (EPOCH) Rochester, Minn.

  The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere.

• A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients With Stage III Colon Cancer Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It was not known at the time this study was developed which combination chemotherapy regimen is more effective after surgery in treating colon cancer. This study had several key changes, based on the results of other phase III trials. As of 6/1/2005, patients no longer received irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C and F who had not gotten to irinotecan continued on arms A and D, respectively. As of 8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm A and arm D. Patients on arm G were treated per physician discretion and followed for disease and survival status. KRAS was determined in a central laboratory and was process for all patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus on patients having wild-type KRAS tumors. All modifications were approved by the Central Institution Review Board, local Institutional Review Boards, NCI, and the NCCTG Data Safety Monitoring Board.

• N0147SS2, Alcohol Consumption and Survival After Colon Cancer Diagnosis Rochester, Minn.

  The purpose of this study is to assess the relationship between lifetime and recent alcohol consumption history and disease free survival in a population of stage III colon cancer patients treated with chemotherapy and curative surgical resection.

• Phase I/II Study of LY2090314 and Chemotherapy in Metastatic Pancreatic Cancer Patients with Metastases Amenable to Biopsy Rochester, Minn., Jacksonville, Fla.

  Purpose of this phase I/II study is to test how well LY2090314 works in combination with different chemotherapies in treating participants with metastatic pancreatic cancer.

• Pilot Trial of Sirolimus, Gemcitabine and Cisplatin for Patients With High Risk for Cholangiocarcinoma Recurrence Rochester, Minn. This pilot phase I trial studies the side effects and best way to give sirolimus, gemcitabine hydrochloride, and cisplatin in treating patients at high risk for cholangiocarcinoma recurrence after liver transplant or surgery. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sirolimus with gemcitabine hydrochloride and cisplatin may be an effective treatment for patients with a high risk of cancer recurrence after a liver transplant or surgery.