Bevacizumab, Radiation Therapy, and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal Cancer
NCT ID: NCT00321685
Last Updated: 2019-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2006-07-25
2019-02-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (bevacizumab and chemoradiotherapy)
See Detailed Description
Bevacizumab
Given IV
Capecitabine
Given PO
Fluorouracil
Given IV
Leucovorin Calcium
Given IV
Oxaliplatin
Given IV
Radiation Therapy
Undergo radiotherapy
Therapeutic Conventional Surgery
Undergo surgical resection
Interventions
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Bevacizumab
Given IV
Capecitabine
Given PO
Fluorouracil
Given IV
Leucovorin Calcium
Given IV
Oxaliplatin
Given IV
Radiation Therapy
Undergo radiotherapy
Therapeutic Conventional Surgery
Undergo surgical resection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must not have evidence of tumor outside of the pelvis including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy
* Patients must not have intra-operative radiotherapy (IORT) or brachytherapy treatment to the pelvis
* The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of the anal verge by proctoscopic examination
* Transmural penetration of tumor through the muscularis propria must be demonstrated by either of the following: computed tomography (CT) scan plus endorectal ultrasound, or a magnetic resonance imaging (MRI); an endorectal coil or pelvic MRI is allowed
* For the patient to be eligible, the surgeon must prospectively define the tumor as either initially resectable or potentially resectable after pre-operative chemoradiation; clinically resectable tumors are defined as completely resectable with negative margins based on routine examination of the non-anesthetized patient; patients whose tumors are not resectable are not eligible; before pre-operative (op) treatment, the surgeon should estimate and record the type of resection anticipated: pelvic exenteration, posterior pelvic exenteration, APR, LAR, or LAR/coloanal anastomosis
* Patients with tumors that are clinically fixed, clinical stage T4N0-2, M0 are eligible if it is believed that their tumors are potentially resectable after chemoradiation; based on the following:
* Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall or sacrum
* Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack of clear tissue plane will be considered evidence of fixation
* Hydronephrosis on CT scan or intravenous pyelogram (IVP) or ureteric or bladder invasion as documented by cystoscopy and cytology or biopsy, or invasion into prostate
* Vaginal or uterine involvement
* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* A surgical evaluation must confirm patient's ability to tolerate the proposed surgical procedure
* Patients must have a caloric intake \> 1500 kilocalories/day (d)
* Within 4 weeks prior to registration, the patient's absolute neutrophil count (ANC) level must be \>= 1,500/mm\^3
* Within 4 weeks prior to registration, the patients platelet level must be \>= 100,000/mm\^3
* Within 4 weeks prior to registration, serum creatinine must be \< 1.5 X upper limit of normal (ULN); if serum creatinine \> 1.5 x ULN, then creatinine clearance must be \>= 50 mL/mm
* Within 4 weeks prior to registration, serum bilirubin must be =\< 1.5 X ULN
* Within 4 weeks prior to registration, alkaline phosphatase (alk phos) must be \< 2 x ULN
* Within 4 weeks prior to registration, serum glutamic oxaloacetic transaminase (SGOT) must be \< 2 x ULN
* Carcinoembryonic antigen (CEA) must be determined prior to initiation of therapy
* Within 4 weeks prior to registration, urine protein/creatinine (UPC) ratio must be \< 1; patients with a ratio of \>= 1 must undergo a 24-hour urine collection which must be an adequate collection and must demonstrate \< 1 gram (gm) of protein in order to participate
* Within 4 weeks prior to registration, albumin must be \>= 2 gm/dl
* Absence of clinical evidence of high-grade (lumen diameter \< 1 cm) large bowel obstruction, unless diverting colostomy has been performed
* Eligible patients of reproductive potential (both sexes) must agree to use an accepted and effective method of contraceptive during study therapy and for at least 6 months after the completion of bevacizumab
* Women must not be pregnant or breast-feeding; all females of childbearing potential must have a serum pregnancy test to rule out pregnancy within 2 weeks of registration
* Patients must have had no prior chemotherapy for rectal cancer or pelvic irradiation therapy
* Patients with prior malignancies, including pelvic cancer, are eligible if they have been disease free for \> 5 years; patients with prior in situ carcinomas are eligible provided there was complete removal
* Patients must have no active inflammatory bowel disease or other serious medical illness or disease that might limit the patient's ability to receive protocol therapy
* Patients with a history of cerebrovascular accident (CVA)/transient ischemic attack (TIA) at any time, or myocardial infarction/unstable angina within 12 months of study entry are not eligible
* Patients with \> grade 1 peripheral neuropathy are not eligible
* Patients must have urine protein/creatinine (UPC) ratio of \< 1.0; patients with a UPC ratio \>= 1.0 must undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate \< 1 gm of protein in order to participate
* Patients with a history of hypertension must measure \< 150/90 mmHg and be on a stable regimen of anti-hypertensive therapy
* Patients with clinically significant peripheral vascular disease are not eligible
* Patients must not have any of the following:
* Unstable angina (within 12 months of study entry)
* New York Heart Association (NYHA) grade II or higher congestive heart failure
* Evidence of bleeding diathesis/coagulopathy
* Serious non-healing wound or bone fracture
* Patients with a history of the following within 28 days prior to registration are not eligible:
* Abdominal fistula
* Gastrointestinal perforation
* Intrabdominal abscess
* Patients with a history of the following within 28 days prior to day 0 (first treatment day) are not eligible:
* Major surgical procedure
* Open biopsy
* Significant traumatic injury
* Patients must not have core biopsy within 7 days prior to day 0 (first treatment day)
* Patients with prothrombin time (PT) (international normalized ratio \[INR\]) \> 1.5 are not eligible, unless the patient is on full-dose anticoagulants; if so, the following criteria must be met for enrollment:
* The subject must have an in-range INR (usually between 2 and 3), be on a stable dose of warfarin or on a stable dose of low molecular weight heparin
* The subject must not have active bleeding or a pathological condition that is associated with a high risk of bleeding
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Jerome C Landry
Role: PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Locations
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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 Township, New Jersey, United States
Inspira Medical Center Woodbury
Woodbury, New Jersey, United States
Montefiore Medical Center-Wakefield Campus
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The 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
Countries
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References
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Landry JC, Feng Y, Prabhu RS, Cohen SJ, Staley CA, Whittington R, Sigurdson ER, Nimeiri H, Verma U, Benson AB. Phase II Trial of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin, and Bevacizumab Followed by Surgery and Postoperative 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX), and Bevacizumab in Patients With Locally Advanced Rectal Cancer: 5-Year Clinical Outcomes ECOG-ACRIN Cancer Research Group E3204. Oncologist. 2015 Jun;20(6):615-6. doi: 10.1634/theoncologist.2015-0106. Epub 2015 Apr 29.
Other Identifiers
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NCI-2009-01081
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000471148
Identifier Type: -
Identifier Source: secondary_id
ECOG-E3204
Identifier Type: -
Identifier Source: secondary_id
E3204
Identifier Type: OTHER
Identifier Source: secondary_id
E3204
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-01081
Identifier Type: -
Identifier Source: org_study_id
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