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Brief Title: Bevacizumab, Radiation Therapy, and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal Cancer
Official Title: Phase II Study of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin and Bevacizumab Followed by Surgery and Postoperative 5-FU, Leucovorin, Oxaliplatin (FOLFOX) and Bevacizumab in Patients With Locally Advanced Rectal Cancer
Study ID: NCT00321685
Brief Summary: This phase II trial studies how well giving bevacizumab, radiation therapy, and combination chemotherapy works in treating patients who are undergoing surgery for locally advanced nonmetastatic rectal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with radiation therapy and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab together with combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
Detailed Description: PRIMARY OBJECTIVES: I. To evaluate the pathological complete response rate in patients with T3 and T4 rectal cancers when treated preoperatively with capecitabine, oxaliplatin, bevacizumab, and concurrent radiotherapy (XRT). II. To evaluate the resection rate for T3 and T4 rectal cancers and the expected versus actual type of resection (abdominoperinal resection \[APR\] vs. low anterior resection \[LAR\] vs. LAR/coloanal anastomosis). III. To make preliminary observations of patient survival and patterns of recurrence for this treatment combination. IV. To gain additional experience regarding the toxicity and tolerability of this preoperative and postoperative regimen. OUTLINE: PREOPERATIVE CHEMORADIOTHERAPY: Patients undergo radiotherapy (total dose to the tumor bed was 5040 cGy) once daily (QD) 5 days a week and receive capecitabine 825 mg/m\^2 orally (PO) twice daily (BID) 5 days a week for 5.5 weeks. Patients also receive oxaliplatin 50 mg/m\^2 intravenously (IV) over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab 5 mg/kg IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy. SURGERY: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection. Patients whose tumors are not completely resected or who have metastatic disease discontinue protocol therapy. POSTOPERATIVE CHEMOTHERAPY: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium 400 mg/m\^2 IV over 2 hours, and bevacizumab 5 mg/kg IV over 30-90 minutes on day 1. Patients also receive fluorouracil 2400 mg/m\^2 IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Patients then receive up to 3 additional courses of leucovorin calcium, fluorouracil, and bevacizumab. After completion of study treatment, patients are followed up periodically for 10 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Atlanta VA Medical Center, Decatur, Georgia, United States
Medical Center of Central Georgia, Macon, Georgia, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
MacNeal Hospital and Cancer Center, Berwyn, Illinois, United States
Hematology and Oncology Associates, Chicago, Illinois, United States
Northwestern University, Chicago, Illinois, United States
Jesse Brown Veterans Affairs Medical Center, Chicago, Illinois, United States
Mercy Hospital and Medical Center, Chicago, Illinois, United States
Swedish Covenant Hospital, Chicago, Illinois, United States
Presence Saint Joseph Hospital-Chicago, Chicago, Illinois, United States
Saint Anthony Memorial Hospital, Effingham, Illinois, United States
Hematology Oncology Associates of Illinois-Highland Park, Highland Park, Illinois, United States
Hinsdale Hematology Oncology Associates Incorporated, Hinsdale, Illinois, United States
Midwest Center for Hematology Oncology, Joliet, Illinois, United States
Joliet Oncology-Hematology Associates Limited, Joliet, Illinois, United States
NorthShore Hematology Oncology-Libertyville, Libertyville, Illinois, United States
Garneau, Stewart C MD (UIA Investigator), Moline, Illinois, United States
Porubcin, Michael MD (UIA Investigator), Moline, Illinois, United States
Sharis, Christine M MD (UIA Investigator), Moline, Illinois, United States
Spector, David MD (UIA Investigator), Moline, Illinois, United States
Stoffel, Thomas J MD (UIA Investigator), Moline, Illinois, United States
Trinity Medical Center, Moline, Illinois, United States
Vigliotti, Antonio, P.G. M.D. (UIA Investigator), Moline, Illinois, United States
DuPage Medical Group-Ogden, Naperville, Illinois, United States
Illinois Cancer Specialists-Niles, Niles, Illinois, United States
Edward H Kaplan MD and Associates, Skokie, Illinois, United States
Hematology Oncology Associates of Illinois - Skokie, Skokie, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana, United States
Constantinou, Costas L MD (UIA Investigator), Bettendorf, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
Mercy Medical Center-Sioux City, Sioux City, Iowa, United States
Saint Luke's Regional Medical Center, Sioux City, Iowa, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview-Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
Meeker County Memorial Hospital, Litchfield, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
Saint Joseph's Hospital - Healtheast, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States
Woodwinds Health Campus, Woodbury, Minnesota, United States
Nebraska Cancer Research Center, Lincoln, Nebraska, United States
Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center, Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
Virtua Memorial, Mount Holly, New Jersey, United States
Sparta Cancer Treatment Center, Sparta, New Jersey, United States
Virtua Voorhees, Voorhees, New Jersey, United States
Inspira Medical Center Woodbury, Woodbury, New Jersey, United States
Montefiore Medical Center-Wakefield Campus, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, United States
Summa Barberton Hospital, Barberton, Ohio, United States
Mary Rutan Hospital, Bellefontaine, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Grant Medical Center, Columbus, Ohio, United States
Mount Carmel Health Center West, Columbus, Ohio, United States
Doctors Hospital, Columbus, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Saint Rita's Medical Center, Lima, Ohio, United States
Marietta Memorial Hospital, Marietta, Ohio, United States
Licking Memorial Hospital, Newark, Ohio, United States
Springfield Regional Medical Center, Springfield, Ohio, United States
Saint Ann's Hospital, Westerville, Ohio, United States
Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States
Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa, Oklahoma, United States
Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States
Mercy Fitzgerald Hospital, Darby, Pennsylvania, United States
Pocono Medical Center, East Stroudsburg, Pennsylvania, United States
Ephrata Cancer Center, Ephrata, Pennsylvania, United States
Riddle Memorial Hospital, Media, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Aria Health-Torresdale Campus, Philadelphia, Pennsylvania, United States
Einstein Medical Center Philadelphia, Philadelphia, Pennsylvania, United States
Hematology and Oncology Associates of North East Pennsylvania, Scranton, Pennsylvania, United States
Associates In Hematology Oncology PC-Upland, Upland, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Avera McKennan Hospital and University Health Center, Sioux Falls, South Dakota, United States
Medical X-Ray Center, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Name: Jerome C Landry
Affiliation: ECOG-ACRIN Cancer Research Group
Role: PRINCIPAL_INVESTIGATOR