Colon Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

90

Study ID:

NCT00321828

Recruitment Status:

Completed

Sponsor:

NSABP Foundation Inc

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There are 144 Locations for this study

See Locations Near You

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Kaiser Permanente - Fremont
Fremont California, 94538, United States
Kaiser Permanente Medical Center - Hayward
Hayward California, 94545, United States
Scripps Cancer Center - San Diego
La Jolla California, 92037, United States
Kaiser Permanente Medical Center - Oakland
Oakland California, 94611, United States
Kaiser Permanente Medical Center - Redwood City
Redwood City California, 94063, United States
Kaiser Permanente Medical Center - Richmond
Richmond California, 94801, United States
Kaiser Permanente Medical Center - Roseville
Roseville California, 95661, United States
South Sacramento Kaiser-Permanente Medical Center
Sacramento California, 95823, United States
Kaiser Permanente Medical Center - Sacramento
Sacramento California, 95825, United States
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego California, 92120, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco California, 94115, United States
Kaiser Permanente Medical Center - Santa Teresa
San Jose California, 95119, United States
Kaiser Foundation Hospital - San Rafael
San Rafael California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara California, 95051, United States
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa California, 95403, United States
Kaiser Permanente Medical Center - South San Francisco
South San Francisco California, 94080, United States
Kaiser Permanente Medical Facility - Stockton
Stockton California, 95210, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo California, 94589, United States
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek California, 94596, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Sibley Memorial Hospital
Washington District of Columbia, 20016, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland Florida, 33805, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah Georgia, 31403, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago Illinois, 60612, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Advocate Lutheran General Cancer Care Center
Park Ridge Illinois, 60068, United States
Regional Cancer Center at Memorial Medical Center
Springfield Illinois, 62781, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove Indiana, 46107, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Howard Community Hospital
Kokomo Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Reid Hospital & Health Care Services
Richmond Indiana, 47374, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend Indiana, 46617, United States
McFarland Clinic, PC
Ames Iowa, 50010, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
McCreery Cancer Center at Ottumwa Regional
Ottumwa Iowa, 52501, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Louisville Oncology at Norton Cancer Institute - Louisville
Louisville Kentucky, 40202, United States
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore Maryland, 21237, United States
Union Hospital Cancer Program at Union Hospital
Elkton Maryland, 21921, United States
Cancer Institute at St. Joseph Medical Center
Towson Maryland, 21204, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River Massachusetts, 02721, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit Michigan, 48202, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph Michigan, 49085, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield Minnesota, 55355, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood Minnesota, 55109, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis Minnesota, 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale Minnesota, 55422, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee Minnesota, 55379, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury Minnesota, 55125, United States
Missouri Baptist Cancer Center
Saint Louis Missouri, 63131, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research
Saint Louis Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65802, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings Montana, 59101, United States
St. James Healthcare Cancer Care
Butte Montana, 59701, United States
Great Falls Clinic - Main Facility
Great Falls Montana, 59405, United States

Great Falls Montana, 59405, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Methodist Estabrook Cancer Center
Omaha Nebraska, 68114, United States
St. Barnabas Medical Center Cancer Center
Livingston New Jersey, 07039, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse New York, 13057, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls New York, 12801, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
McDowell Cancer Center at Akron General Medical Center
Akron Ohio, 44307, United States
Mary Rutan Hospital
Bellefontaine Ohio, 43311, United States
Aultman Cancer Center at Aultman Hospital
Canton Ohio, 44710, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
Oncology Hematology Care, Incorporated - Blue Ash
Cincinnati Ohio, 45242, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
CCOP - Columbus
Columbus Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus Ohio, 43228, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Good Samaritan Hospital
Dayton Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Dayton Ohio, 45429, United States
Grady Memorial Hospital
Delaware Ohio, 43015, United States
Blanchard Valley Medical Associates
Findlay Ohio, 45840, United States
Middletown Regional Hospital
Franklin Ohio, 45005, United States
Wayne Hospital
Greenville Ohio, 45331, United States
Charles F. Kettering Memorial Hospital
Kettering Ohio, 45429, United States
Fairfield Medical Center
Lancaster Ohio, 43130, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta Ohio, 45750, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark Ohio, 43055, United States
Mercy Medical Center
Springfield Ohio, 45504, United States
Community Hospital of Springfield and Clark County
Springfield Ohio, 45505, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy Ohio, 45373, United States
Mount Carmel St. Ann's Cancer Center
Westerville Ohio, 43081, United States
Clinton Memorial Hospital
Wilmington Ohio, 45177, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia Ohio, 45385, United States
Genesis - Good Samaritan Hospital
Zanesville Ohio, 43701, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Riddle Memorial Hospital Cancer Center
Media Pennsylvania, 19063, United States
Cancer Center of Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
Scranton Pennsylvania, 18508, United States
Mount Nittany Medical Center
State College Pennsylvania, 16803, United States
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
Upland Pennsylvania, 19013, United States
CCOP - Main Line Health
Wynnewood Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas, 79410, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington Vermont, 05401, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States
West Virginia University Health Sciences Center - Charleston
Charleston West Virginia, 25304, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg West Virginia, 26102, United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin, 54449, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

90

Study ID:

NCT00321828

Recruitment Status:

Completed

Sponsor:


NSABP Foundation Inc

How clear is this clinincal trial information?

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