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A Randomized, Prospective Study Comparing Three Regimens Of Eloxatin ™ Plus Fluoropyrimidine For Evaluation Of Safety And Tolerability In First Line Treatment Of Patients With Advanced Colorectal Cancer (Tree Study)


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

Thank you

Trial Information

A Randomized, Prospective Study Comparing Three Regimens Of Eloxatin ™ Plus Fluoropyrimidine For Evaluation Of Safety And Tolerability In First Line Treatment Of Patients With Advanced Colorectal Cancer (Tree Study)


OBJECTIVES:

- Compare the incidence of grade 3 and 4 toxic effects occurring within the first 12
weeks of treatment with 2 different schedules of oxaliplatin, bevacizumab (Avastin™),
leucovorin calcium, and fluorouracil or with oxaliplatin, Avastin™, and capecitabine in
patients with advanced colorectal cancer.

- Compare the overall response rate, progression-free survival, and time to treatment
failure in patients treated with these regimens.

- Compare the composite toxicity of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1
of 3 treatment arms.

- Arm I: Patients receive bevacizumab (Avastin™) IV over 30-90 minutes, oxaliplatin IV
over 2 hours, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil (5-FU)
IV over 46 hours beginning on day 1. Courses repeat every 14 days in the absence of
disease progression or unacceptable toxicity.

- Arm II: Patients receive Avastin™ IV over 30-90 minutes and oxaliplatin IV over 2 hours
on days 1 and 15 and leucovorin calcium IV over 10 minutes and 5-FU IV over 3 minutes
on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.

- Arm III: Patients receive Avastin™ IV over 30-90 minutes and oxaliplatin IV over 2
hours on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month, every 3 months for at least 2 years, and then every 6
months thereafter.

PROJECTED ACCRUAL: A total of 375 patients (125 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the colon or rectum

- Metastatic or recurrent disease not amenable to potentially curative treatment

- At least 1 unidimensionally measurable lesion at least 20 mm by conventional
techniques OR at least 10 mm by spiral CT scan

- Histological or cytological confirmation is required for a solitary target
lesion

- No CNS metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

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 2 times upper limit of normal (ULN)

- SGPT and SGOT no greater than 3 times ULN

Renal

- Creatinine no greater than 1.5 times ULN

- Creatinine clearance at least 30 mL/min

Cardiovascular

- No myocardial infarction within the past 6 months

- No clinical evidence of congestive heart failure

- No unstable coronary artery disease

Pulmonary

- No interstitial pneumonia

- No extensive symptomatic fibrosis of the lungs

Gastrointestinal

- Able to tolerate oral medication

- No lack of physical integrity of the upper gastrointestinal tract

- No malabsorption syndrome

- No swallowing difficulties

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
participation

- No other concurrent serious illness

- No uncontrolled infection

- No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of
the cervix or any other cancer for which the patient has been off all therapy and in
remission for at least 5 years

- No peripheral neuropathy

- No hypersensitivity to any of the study drugs or their ingredients

- No known dihydropyrimidine dehydrogenase deficiency

- No other medical or psychiatric disorder that would preclude giving informed consent
or complying with study

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent prophylactic hematopoietic growth factor therapy

- No prior bevacizumab (Avastin™)

Chemotherapy

- At least 6 months since prior adjuvant fluorouracil, leucovorin calcium, and
irinotecan

- No prior oxaliplatin

- No prior chemotherapy for metastatic or recurrent disease

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No concurrent radiotherapy unless for the control of bone pain

Surgery

- Recovered from prior surgery

- No prior organ allografts

Other

- More than 4 weeks since prior investigational drugs

- No concurrent iced mouth rinses for the prevention of stomatitis

- No concurrent cold cap alopecia prevention

- No concurrent pyridoxine

- No concurrent sorivudine or chemically-related analogues (e.g., brivudine)

- No concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, or warfarin

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Richard A. Gams, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Prologue Research International

Authority:

United States: Federal Government

Study ID:

CDR0000304771

NCT ID:

NCT00062426

Start Date:

May 2003

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • recurrent colon cancer
  • stage IV colon cancer
  • recurrent rectal cancer
  • stage IV rectal cancer
  • Colorectal Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - WichitaWichita, Kansas  67214-3882
Medical City Dallas HospitalDallas, Texas  75230
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Greater Baltimore Medical Center and Cancer CenterBaltimore, Maryland  21204
New York Medical CollegeValhalla, New York  10595
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Saint Anthony Medical CenterRockford, Illinois  61108
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
California Cancer Care, Inc.Greenbrae, California  94904-2007
Hematology Oncology Consultants IncColumbus, Ohio  43235
North Idaho Cancer CenterCoeur d'Alene, Idaho  83814
South Texas Oncology and HematologySan Antonio, Texas  78229
Deaconess Billings Clinic Cancer CenterBillings, Montana  59107
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Center for Cancer Prevention and Care at Scott and White ClinicTemple, Texas  76508
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
St. Vincents Comprehensive Cancer CenterNew York, New York  10011
Florida Cancer SpecialistsFort Myers, Florida  33901
Lone Star OncologyAustin, Texas  78759
Northwestern Connecticut Oncology-Hematology AssociatesTorrington, Connecticut  06790
Arena Oncology AssociatesGreat Neck, New York  11021
Cancer and Blood Institute of the DesertRancho Mirage, California  92270
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Sarah Cannon Cancer Center at Centennial Medical CenterNashville, Tennessee  37203
Arizona Clinical Research CenterTucson, Arizona  85712
Valley Tumor Medical GroupLancaster, California  93534
Jackson Oncology Associates, PLLCJackson, Mississippi  39202
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
Florida Oncology AssociatesOrange Park, Florida  32073
Memphis Cancer CenterMemphis, Tennessee  38119
Charleston Hematology-Oncology, P.A.Charleston, South Carolina  29403
North Shore Hematology/Oncology Associates, P.C.East Setauket, New York  11733
Hematology and Oncology Consultants, P.A.Orlando, Florida  32804
West ClinicMemphis, Tennessee  38117
Advanced Oncology AssociatesArmonk, New York  10504
New York University Medical CenterNew York, New York  10016
Rocky Mountain Cancer Centers - MidtownDenver, Colorado  80218
Lynn Regional Cancer Center WestBoca Raton, Florida  33428
Peachtree Hematology and Oncology Consultants, P.C.Atlanta, Georgia  30309
Hematology Oncology Associates of theTreasure Coast - Port St. LuciePort Saint Lucie, Florida  34952
Cooper Cancer Institute at Cooper University HospitalVoorhees, New Jersey  08043
Physicians East - QuadrangleGreenville, North Carolina  27834
Raleigh Hematology/Oncology Associates, P.A. - Wake PracticeRaleigh, North Carolina  27609-7300
Hematology/Oncology of SalemSalem, Oregon  97301
McCleod Cancer and Blood CenterJohnson City, Tennessee  37604
Medical ConsultantsMilwaukee, Wisconsin  53215-3690