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)
18 Years
N/A
Both
Colorectal Cancer
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 Center | Durham, North Carolina 27710 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| Medical City Dallas Hospital | Dallas, Texas 75230 |
| Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
| Greater Baltimore Medical Center and Cancer Center | Baltimore, Maryland 21204 |
| New York Medical College | Valhalla, New York 10595 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
| West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
| Saint Anthony Medical Center | Rockford, Illinois 61108 |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
| California Cancer Care, Inc. | Greenbrae, California 94904-2007 |
| Hematology Oncology Consultants Inc | Columbus, Ohio 43235 |
| North Idaho Cancer Center | Coeur d'Alene, Idaho 83814 |
| South Texas Oncology and Hematology | San Antonio, Texas 78229 |
| Deaconess Billings Clinic Cancer Center | Billings, Montana 59107 |
| Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
| Center for Cancer Prevention and Care at Scott and White Clinic | Temple, Texas 76508 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| St. Vincents Comprehensive Cancer Center | New York, New York 10011 |
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Lone Star Oncology | Austin, Texas 78759 |
| Northwestern Connecticut Oncology-Hematology Associates | Torrington, Connecticut 06790 |
| Arena Oncology Associates | Great Neck, New York 11021 |
| Cancer and Blood Institute of the Desert | Rancho Mirage, California 92270 |
| Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
| Sarah Cannon Cancer Center at Centennial Medical Center | Nashville, Tennessee 37203 |
| Arizona Clinical Research Center | Tucson, Arizona 85712 |
| Valley Tumor Medical Group | Lancaster, California 93534 |
| Jackson Oncology Associates, PLLC | Jackson, Mississippi 39202 |
| Southeastern Medical Oncology Center | Goldsboro, North Carolina 27534 |
| Pennsylvania Oncology Hematology Associates | Philadelphia, Pennsylvania 19107 |
| Florida Oncology Associates | Orange Park, Florida 32073 |
| Memphis Cancer Center | Memphis, 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 Clinic | Memphis, Tennessee 38117 |
| Advanced Oncology Associates | Armonk, New York 10504 |
| New York University Medical Center | New York, New York 10016 |
| Rocky Mountain Cancer Centers - Midtown | Denver, Colorado 80218 |
| Lynn Regional Cancer Center West | Boca Raton, Florida 33428 |
| Peachtree Hematology and Oncology Consultants, P.C. | Atlanta, Georgia 30309 |
| Hematology Oncology Associates of theTreasure Coast - Port St. Lucie | Port Saint Lucie, Florida 34952 |
| Cooper Cancer Institute at Cooper University Hospital | Voorhees, New Jersey 08043 |
| Physicians East - Quadrangle | Greenville, North Carolina 27834 |
| Raleigh Hematology/Oncology Associates, P.A. - Wake Practice | Raleigh, North Carolina 27609-7300 |
| Hematology/Oncology of Salem | Salem, Oregon 97301 |
| McCleod Cancer and Blood Center | Johnson City, Tennessee 37604 |
| Medical Consultants | Milwaukee, Wisconsin 53215-3690 |
