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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Major Morbidity Related to the Intact Primary Tumor

Outcome Description:

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.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Norman Wolmark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NSABP Foundation, Inc.

Authority:

United States: Federal Government

Study ID:

NSABP C-10

NCT ID:

NCT00321828

Start Date:

March 2006

Completion Date:

December 2012

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the colon
  • stage IV colon cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Kaiser Permanente Medical Center - San Francisco Geary CampusSan Francisco, California  94115
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
McCreery Cancer Center at Ottumwa RegionalOttumwa, Iowa  52501
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Mount Nittany Medical CenterState College, Pennsylvania  16803
Sibley Memorial HospitalWashington, District of Columbia  20016
Southwest Medical CenterLiberal, Kansas  67901
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California  95051-5386
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Advocate Lutheran General Cancer Care CenterPark Ridge, Illinois  60068-1174
St. Barnabas Medical Center Cancer CenterLivingston, New Jersey  07039
West Virginia University Health Sciences Center - CharlestonCharleston, West Virginia  25302
Kaiser Permanente Medical Center - SacramentoSacramento, California  95825
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital CenterBaltimore, Maryland  21237
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
Kaiser Permanente - FremontFremont, California  94538
Kaiser Permanente Medical Center - HaywardHayward, California  94545
Kaiser Permanente Medical Center - Redwood CityRedwood City, California  94063
Kaiser Permanente Medical Center - RichmondRichmond, California  94801
Kaiser Permanente Medical Center - RosevilleRoseville, California  95661
South Sacramento Kaiser-Permanente Medical CenterSacramento, California  95823
Kaiser Permanente Medical Office -Vandever Medical OfficeSan Diego, California  92120
Kaiser Permanente Medical Center - Santa TeresaSan Jose, California  95119
Kaiser Foundation Hospital - San RafaelSan Rafael, California  94903
Kaiser Permanente Medical Center - Santa RosaSanta Rosa, California  95403
Kaiser Permanente Medical Center - South San FranciscoSouth San Francisco, California  94080
Kaiser Permanente Medical Facility - StocktonStockton, California  95210
Kaiser Permanente Medical Center - Walnut CreekWalnut Creek, California  94596
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
Mercy Medical CenterSpringfield, Ohio  45504
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Danville Regional Medical CenterDanville, Virginia  24541
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Arch Medical Services, Incorporated at Center for Cancer Care and ResearchSaint Louis, Missouri  63141
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Mary Rutan HospitalBellefontaine, Ohio  43311
Grant Medical Center Cancer CareColumbus, Ohio  43215
Wayne HospitalGreenville, Ohio  45331
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Clinton Memorial HospitalWilmington, Ohio  45177
Hematology and Oncology Associates of Northeastern PennsylvaniaScranton, Pennsylvania  18510
Community Comprehensive Cancer Center at Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
John H. Stroger, Jr. Hospital of Cook CountyChicago, Illinois  60612-9985
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Louisville Oncology at Norton Cancer Institute - LouisvilleLouisville, Kentucky  40202
Scripps Cancer Center - San DiegoSan Diego, California  92121
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Riddle Memorial Hospital Cancer CenterMedia, Pennsylvania  19063
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096
Associates in Hematology-Oncology, PC at Crozer Regional Cancer CenterUpland, Pennsylvania  19013
Hudner Oncology Center at Saint Anne's Hospital - Fall RiverFall River, Massachusetts  02721
Cancer Institute at St. Joseph Medical CenterTowson, Maryland  21204
Oncology Hematology Care, Incorporated - Blue AshCincinnati, Ohio  45242