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A Multicenter, Open-Label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of Metastatic Colorectal Carcinoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

A Multicenter, Open-Label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of Metastatic Colorectal Carcinoma


OBJECTIVES:

- Compare the overall survival of patients with metastatic colorectal cancer treated with
irinotecan with or without oxaliplatin.

- Compare the response rate, time to tumor-related worsening of symptoms, time to disease
progression, onset and duration of responses, and duration of disease stabilization in
these patients treated with these regimens.

- Compare the safety of these regimens in these patients.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs
involved (1 vs 2 or more), lactic dehydrogenase (no greater than 1.5 times upper limit of
normal (ULN) vs greater than 1.5 times ULN), and prior fluorouracil chemotherapy (adjuvant
vs first-line treatment for metastatic disease). Patients are randomized to 1 of 2 treatment
arms.

- Arm I: Patients receive irinotecan IV over 90 minutes on day 1.

- Arm II: Patients receive oxaliplatin IV over 120 minutes followed by irinotecan IV over
30 minutes on day 1.

Courses repeat in each arm every 3 weeks for 1 year in the absence of disease progression or
unacceptable toxicity.

Patients are followed at 30 days, every 4 weeks for 3 months, and then every 3 months
thereafter.

PROJECTED ACCRUAL: A total of 596 patients (298 per arm) will be accrued for this study
within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum

- Metastatic or recurrent disease that is not amenable to potentially curative
treatment

- Progressive or recurrent disease during or after 1, and only 1, regimen of
fluorouracil with or without leucovorin calcium or during or within 6 months after
adjuvant chemotherapy with fluorouracil and leucovorin calcium

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 50-100%

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT/SGPT no greater than 2 times ULN (no greater than 5 times ULN if liver
metastases present)

- Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if
liver metastases present)

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No unstable angina

- No New York Heart Association class III or IV congestive heart failure

- No serious cardiac arrhythmia

- No history of cardiac toxicity from fluorouracil/leucovorin calcium

- No myocardial infarction within past 6 months

Pulmonary:

- No interstitial pneumonia or extensive and symptomatic fibrosis of the lung

Other:

- No uncontrolled predisposing colonic or small bowel disorder

- No prior chronic enteropathy, chronic diarrhea, or unresolved bowel
obstruction/subobstruction

- No diabetes

- No active infection

- No known current peripheral neuropathy

- No concurrent active cancer except curatively treated nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No intolerance of appropriate antiemetics

- No history of anaphylaxis or potential intolerance to atropine sulfate or loperamide

- Not pregnant or nursing

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy

- No prior irinotecan or oxaliplatin

- No other prior chemotherapy agents except fluorouracil with or without leucovorin
calcium as first-line therapy for metastatic disease or in the adjuvant setting

Endocrine therapy:

- Not specified

Radiotherapy:

- Prior radiotherapy to non-target lesions allowed

- No prior radiotherapy to target lesions unless disease progression is documented
within the radiation port

- At least 3 weeks since prior radiotherapy

Surgery:

- At least 4 weeks since prior major surgical procedure and recovered

- Prior surgery for primary tumor or metastasis allowed

Other:

- At least 30 days since prior investigational drug

- No concurrent investigational agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Daniel G. Haller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Federal Government

Study ID:

CDR0000068524

NCT ID:

NCT00012389

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

Name

Location

George Washington University Medical CenterWashington, District of Columbia  20037
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Baptist Regional Cancer Center - KnoxvilleKnoxville, Tennessee  37901
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Whittingham Cancer CenterNorwalk, Connecticut  06856
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Greater Baltimore Medical Center and Cancer CenterBaltimore, Maryland  21204
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
New York Medical CollegeValhalla, New York  10595
Virginia Mason Medical CenterSeattle, Washington  98111
John Wayne Cancer InstituteSanta Monica, California  90404
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Comprehensive Cancer Institute of HuntsvilleHuntsville, Alabama  35801
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Cooper Cancer InstituteCamden, New Jersey  08103
Great Falls ClinicGreat Falls, Montana  59405
California Cancer Care, Inc.Greenbrae, California  94904-2007
Hematology Oncology Consultants IncColumbus, Ohio  43235
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
North Idaho Cancer CenterCoeur d'Alene, Idaho  83814
Interlakes Oncology/Hematology PCRochester, New York  14623
Montefiore Medical CenterBronx, New York  10467-2490
Somerset Medical CenterSomerville, New Jersey  08876
Rocky Mountain Cancer CenterDenver, Colorado  80218
Oncology-Hematology Group of South FloridaMiami, Florida  33176
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Oncology Center at Providence ParkMobile, Alabama  36608
Colorado Permanente Medical Group, P.C.Denver, Colorado  80205
Florida Cancer SpecialistsFort Myers, Florida  33901
Northwest Medical Specialists, P.C.Arlington Heights, Illinois  60004
Louisiana Oncology AssociatesLafayette, Louisiana  70506
Lone Star OncologyAustin, Texas  78759
University of Florida Health Science Center - JacksonvilleJacksonville, Florida  32209
Pinnacle Health HospitalsHarrisburg, Pennsylvania  17105-8700
UW Cancer Center Wausau HospitalWausau, Wisconsin  54401
Cancer Care CenterNew Albany, Indiana  47150
Cancer and Blood Institute of the DesertRancho Mirage, California  92270
St. John's Mercy Medical CenterSaint Louis, Missouri  63141
Lakeland Regional Medical CenterLakeland, Florida  33804
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Norton Healthcare PavilionLouisville, Kentucky  40202
Arizona Clinical Research CenterTucson, Arizona  85712
Siteman Cancer CenterSaint Louis, Missouri  63110
Jackson Oncology Associates, PLLCJackson, Mississippi  39202
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
Stanley Scott Cancer CenterNew Orleans, Louisiana  70112
Comprehensive Cancer Care Specialists of Boca RatonBoca Raton, Florida  33428
Hematology/Oncology AssociatesPort Saint Lucie, Florida  34952
Tower Hematology Oncology Medical GroupLos Angeles, California  90048
Raleigh Hematology/Oncology Associates - Wake PracticeRaleigh, North Carolina  27609
Center for Oncology Research and Treatment, Medical City HospitalDallas, Texas  75230
Memphis Cancer CenterMemphis, Tennessee  38119
Abington Hematology Oncology Associates, IncorporatedAbington, Pennsylvania  19001
Center for Hematology-OncologyBoca Raton, Florida  33486
Southeast Florida Hematology-Oncology GroupFort Lauderdale, Florida  33308
Erlanger Health SystemsChattanooga, Tennessee  37403
Medical Oncology Care AssociatesOrange, California  92668
P.M.K. Medical Group, Inc.Oxnard, California  93030
Oncology & Hematology Associates of West BrowardTamarac, Florida  33321
Hematology and Oncology ConsultantsTitusville, Florida  32796
Dreyer Medical ClinicAurora, Illinois  60506
Northwestern Medical Faculty FoundationChicago, Illinois  60611
Parker Hughes Cancer CenterRoseville, Minnesota  55113
Missouri Cancer Care, P.C.St. Charles, Missouri  63301
Baptist Health System Cancer ProgramSan Antonio, Texas  78205
Hematology-Oncology Associates of Frederiksburg, Inc.Fredericksburg, Virginia  22401
Advanced Health CareMilwaukee, Wisconsin  53209
Fountain Valley, California  92708
Citrus Valley Medical CenterCovina, California  91722
Kenmar Research InstituteLos Angeles, California  90057
Hematology and Oncology Associates of JacksonvilleJacksonville, Florida  32207
Lake Heart and Cancer Medical CenterLeesburg, Florida  34748
Hematology and Oncology Consultants, P.A.Orlando, Florida  32804
University Community HospitalTampa, Florida  33613
Kentuckiana Cancer InstituteLouisville, Kentucky  40202
Veterans Affairs Medical Center - LouisvilleLouisville, Kentucky  40206
Doctors Hospital of JeffersonMetairie, Louisiana  70006
Medical Center of BostonBoston, Massachusetts  02120
Berkshire Hematology Oncology, P.C.Pittsfield, Massachusetts  01201
Flint, Michigan  48532
Western Montana ClinicMissoula, Montana  59807-7609
Queens Medical Associates, PCFresh Meadows, New York  11365
Queens Hospital CenterJamaica, New York  11432
Piedmont Hematology-Oncology AssociatesWinston-Salem, North Carolina  27103
Bend Memorial ClinicBend, Oregon  97701
Kaiser Permanente - PortlandPortland, Oregon  97227
Physicians East - QuadrangleGreenville, South Carolina  27834
West ClinicMemphis, Tennessee  38117
Tennessee Oncology, P.L.L.C.Nashville, Tennessee  37205
Irving Cancer CenterLaramie, Wyoming  82070