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Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00321828
Recruitment Status : Completed
First Posted : May 4, 2006
Results First Posted : January 14, 2013
Last Update Posted : January 24, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NSABP Foundation Inc

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colon cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colon cancer that cannot be removed by surgery.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: bevacizumab Drug: fluorouracil Drug: leucovorin Drug: oxaliplatin Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • Determine the rate of major morbidity in patients with unresectable stage IV colon cancer and a synchronous asymptomatic primary tumor treated with fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX6) in combination with bevacizumab without resection of the primary tumor.

Secondary

  • Determine the rate of specific events related to the intact primary tumor requiring hospitalization or a major intervention but not requiring surgery.
  • Determine the rate of ≥ grade 3 toxicity as defined by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) that is related to study therapy prior to disease progression.
  • Determine overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV given concurrently with leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years after study entry.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6) Chemotherapy Plus Bevacizumab for Patients With Unresectable Stage IV Colon Cancer and a Synchronous Asymptomatic Primary Tumor
Study Start Date : March 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Biological: bevacizumab
bevacizumab 5 mg/kg IV on day 1 every 14 days until excessive toxicity or disease progression

Drug: fluorouracil
5-FU 400 mg/m2 IV bolus over 2-4 minutes then 2400 mg/m2 IV continuous infusion over 46 hours on day 1 every 14 days until excessive toxicity or disease progression
Other Name: 5-FU

Drug: leucovorin
leucovorin 400 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression
Other Name: leucovorin calcium

Drug: oxaliplatin
Oxaliplatin 85 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression




Primary Outcome Measures :
  1. Major Morbidity Related to the Intact Primary Tumor [ Time Frame: 24 months ]
    Cumulative incidence was used to compute percent probability of morbidity. Cumulative incidence at time t measures the probability of a participant having an event (i.e., Colonic bleeding, perforation, bowel obstruction, or fistula formation requiring surgery or resulting in patient death) over the given duration, t. It involves computing the probability of an event at any observed time (i.e., the number of new cases during a period divided by the number of subjects at risk) and multiplying these successive probabilities by any early computed probability to get the final estimate.


Secondary Outcome Measures :
  1. Local Complications as Assessed by Colonic Obstruction Requiring Hospitalization (But Not Surgery) for Medical Management, Stent Placement, Laser Treatment, or Fulguration [ Time Frame: Time from start of study through year 5 ]
  2. Local Complications as Assessed by Gastrointestinal Bleeding Requiring Transfusion But Not Requiring Surgery [ Time Frame: Time from start of study through year 5 ]
  3. Local Complications as Assessed by Fistula Formation (Self-draining Enterocutaneous Fistula and Intra-abdominal Abscess Requiring Percutaneous Drainage) Not Requiring Surgery [ Time Frame: Time from start of study through year 5 ]
  4. Local Complications as Assessed by Other Events Related to the Intact Primary Tumor Which Require Hospitalization But Not Surgery [ Time Frame: Time from start of study through year 5 ]
  5. Serious Adverse Events (Grades 3, 4, and 5) as Defined by CTCAE v3.0 [ Time Frame: Time from start of study through year 5 ]
  6. Overall Survival as Measured by Death From Any Cause [ Time Frame: Time from start of study through year 5 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the colon

    • No histological findings other than adenocarcinoma of the colon
    • If the primary colon tumor and the metastatic lesions have been identified at the same time and it is not possible to biopsy the colonic lesion, the patient will be eligible without histologic confirmation of the primary cancer of the colon as long as other radiographic studies or scans document the characteristics of a colon cancer AND the biopsy of a metastatic site confirms diagnosis of adenocarcinoma suggestive of a primary tumor of the colon
  • Unresected primary tumor of the colon AND radiographically confirmed metastatic colon cancer (single or multiple sites of metastases) that are not considered surgically resectable for cure by chest imaging and CT scan or MRI of the abdomen within the past 4 weeks and by endoscopy within the past 8 weeks
  • Asymptomatic primary tumor

    • No obstruction, perforation, or active bleeding requiring transfusion
  • Distal extent of the tumor must be ≥ 12 cm from the anal verge on endoscopy
  • Not a candidate for curative surgical resection of all metastatic and colon primary tumors
  • No evidence of Central Nervous System (CNS) metastases
  • No recurrent local or metastatic disease after prior adjuvant therapy
  • No diagnosis of rectal carcinoma

PATIENT CHARACTERISTICS:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Absolute neutrophil count ≥ 1200/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if liver metastases are present)
  • Alkaline phosphatase ≤ 3.0 times ULN (≤ 5.0 times ULN if liver metastases are present)
  • Bilirubin ≤ 1.5 times ULN (≤ 2.0 times ULN if liver metastases are present)
  • Creatinine < 1.8 mg/dL
  • Urine dipstick indicating 0-1+ protein

    • If dipstick reading is ≥ 2+, a 24-hour urine collection must demonstrate < 1 g of protein
  • Prothrombin Time and International Normalized Ratio (PT/INR) ≤ 1.5 unless the patient is on therapeutic doses of warfarin, in which case the following criteria must be met:

    • Patient must have an in-range INR (between 2 and 3) on a stable dose of warfarin
    • Patient must not have active bleeding or a pathologic condition that is associated with a high risk of bleeding
  • Patients with a history of non-colorectal malignancies must be disease free for ≥ 5 years prior to study entry and be deemed at low risk for recurrence
  • Patients with the following cancers are eligible if diagnosed and treated within the past 5 years:

    • Carcinoma in situ of the colon
    • Melanoma in situ
    • Basal cell or squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after the completion of study therapy
  • No uncontrolled blood pressure (BP), defined as BP > 150/100 mm Hg
  • No nonmalignant systemic disease that would preclude any of the study therapy drugs, compromise the safety of the patient, or inhibit the patient's ability to participate in the study, including any of the following:

    • New York Heart Association class III or IV cardiac disease
    • Myocardial infarction within the past 6 months
    • Unstable angina within the past 6 months
    • Symptomatic arrhythmia
  • No transient ischemic attack or cerebrovascular accident within the past 6 months
  • No symptomatic peripheral vascular ischemia within the past 6 months
  • No arterial thrombotic event within the past 6 months
  • No gastroduodenal ulcer(s) determined by endoscopy to be active
  • No gastrointestinal perforation within the past 12 months
  • No serious or nonhealing wound, skin ulcer, or bone fracture
  • No significant traumatic injury within the past 28 days
  • No significant episodes of acute bleeding requiring blood transfusion within the past 6 months
  • No clinically significant (≥ grade 2) peripheral neuropathy (neurosensory or neuromotor toxicity)
  • No pulmonary fibrosis or interstitial pneumonitis by chest x-ray
  • No psychiatric or addictive disorders or other conditions that would preclude the patient from meeting study requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic chemotherapy, radiation therapy, or surgery for this malignancy
  • No prior endoscopic management of this malignancy other than biopsy, including endoscopic stent placement, fulguration, or laser treatment
  • More than 30 days since prior investigational drugs
  • More than 28 days since prior major surgical procedure or open biopsy
  • More than 7 days since prior core biopsy or other minor procedure, excluding placement of a vascular access device
  • No concurrent major surgery unrelated to intact primary colon cancer
  • No concurrent radiotherapy
  • No concurrent filgrastim (G-CSF) or pegfilgrastim as primary prophylaxis for neutropenia
  • No concurrent halogenated antiviral agents
  • No other concurrent investigational drugs
  • No other concurrent antineoplastic agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321828


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Locations
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United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Kaiser Permanente - Fremont
Fremont, California, United States, 94538
Kaiser Permanente Medical Center - Hayward
Hayward, California, United States, 94545
Scripps Cancer Center - San Diego
La Jolla, California, United States, 92037
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States, 94611
Kaiser Permanente Medical Center - Redwood City
Redwood City, California, United States, 94063
Kaiser Permanente Medical Center - Richmond
Richmond, California, United States, 94801
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States, 95661
South Sacramento Kaiser-Permanente Medical Center
Sacramento, California, United States, 95823
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States, 95825
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California, United States, 92120
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, United States, 94115
Kaiser Permanente Medical Center - Santa Teresa
San Jose, California, United States, 95119
Kaiser Foundation Hospital - San Rafael
San Rafael, California, United States, 94903
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States, 95051
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa, California, United States, 95403
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, United States, 94080
Kaiser Permanente Medical Facility - Stockton
Stockton, California, United States, 95210
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States, 94589
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek, California, United States, 94596
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805
United States, Georgia
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Illinois
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, United States, 52501
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Louisville Oncology at Norton Cancer Institute - Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Union Hospital Cancer Program at Union Hospital
Elkton MD, Maryland, United States, 21921
Cancer Institute at St. Joseph Medical Center
Towson, Maryland, United States, 21204
United States, Massachusetts
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States, 02721
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
Arch Medical Services, Incorporated at Center for Cancer Care and Research
Saint Louis, Missouri, United States, 63141
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Great Falls, Montana, United States, 59405
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Community Medical Center
Missoula, Montana, United States, 59801
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Jersey
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States, 07039
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States, 12801
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States, 44710-1799
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Oncology Hematology Care, Incorporated - Blue Ash
Cincinnati, Ohio, United States, 45242
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
CCOP - Columbus
Columbus, Ohio, United States, 43215
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Grandview Hospital
Dayton, Ohio, United States, 45405
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
CCOP - Dayton
Dayton, Ohio, United States, 45429
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Mercy Medical Center
Springfield, Ohio, United States, 45504
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Riddle Memorial Hospital Cancer Center
Media, Pennsylvania, United States, 19063
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Hematology and Oncology Associates of Northeastern Pennsylvania
Scranton, Pennsylvania, United States, 18508
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
Upland, Pennsylvania, United States, 19013
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States, 19096
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Texas
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
United States, West Virginia
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States, 25304
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26102
United States, Wisconsin
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
NSABP Foundation Inc
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc

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Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00321828     History of Changes
Other Study ID Numbers: NSABP C-10
U10CA012027 ( U.S. NIH Grant/Contract )
CDR0000463513 ( Other Identifier: NCI )
First Posted: May 4, 2006    Key Record Dates
Results First Posted: January 14, 2013
Last Update Posted: January 24, 2013
Last Verified: January 2013
Keywords provided by NSABP Foundation Inc:
adenocarcinoma of the colon
stage IV colon cancer
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Bevacizumab
Oxaliplatin
Fluorouracil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors