Combination Chemotherapy Plus Bevacizumab With or Without Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer
Status: | Recruiting |
---|---|
Conditions: | Colorectal Cancer, Cancer, Cognitive Studies, Neurology |
Therapuetic Areas: | Neurology, Oncology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | January 2011 |
Randomized Phase III Trial of mFOLFOX7 or XELOX Plus Bevacizumab Versus 5-Fluorouracil/Leucovorin or Capecitabine Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. Giving more than one
drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as
bevacizumab, can block cancer growth in different ways. Some block the ability of cancer
cells to grow and spread. Others find cancer cells and help kill them or carry
cancer-killing substances to them. Bevacizumab may also stop the growth of cancer by
blocking blood flow to the tumor. It is not yet known whether combination chemotherapy plus
bevacizumab is more effective with or without oxaliplatin in treating colorectal cancer.
PURPOSE: This randomized phase III clinical trial is studying how well combination
chemotherapy plus bevacizumab with or without oxaliplatin works in treating older patients
with metastatic colorectal cancer.
OBJECTIVES:
Primary
- To compare the progression-free survival (PFS) of elderly patients with metastatic
colorectal carcinoma who are randomized to receive fluoropyrimidine-based therapy plus
bevacizumab, with or without oxaliplatin.
Secondary
- In a prospectively planned pooled analysis with a similar trial to be conducted by the
Japanese Clinical Oncology Group (JCOG), evaluate and compare the overall survival (OS)
of elderly patients with metastatic colorectal carcinoma who are randomized to receive
fluoropyrimidine-based therapy plus bevacizumab, with or without oxaliplatin.
- To assess and compare response rates and adverse events of elderly patients with
metastatic colorectal carcinoma randomized to receive fluoropyrimidine-based therapy
plus bevacizumab, with or without oxaliplatin.
Tertiary (correlative)
- To evaluate the quality of life (QoL) in elderly patients with metastatic colorectal
carcinoma randomized to receive fluoropyrimidine-based therapy plus bevacizumab, with
or without oxaliplatin.
- To determine whether a geriatric/frailty assessment predicts overall ≥ grade 3 toxicity
to chemotherapy and is associated with PFS, OS, overall QoL, hospitalization, dose
modification (delay or reduction), or discontinuation of chemotherapy due to toxicity,
morbidity, or mortality in elderly patients with metastatic colorectal cancer
randomized to receive fluoropyrimidine-based therapy plus bevacizumab, with or without
oxaliplatin.
- Determine whether a geriatric/frailty assessment tool can identify a subgroup of
elderly patients who benefit from oxaliplatin-based chemotherapy as first-line
treatment of metastatic colorectal carcinoma.
- To analyze relevant pharmacogenetic markers in tissue and blood that may predict
toxicity and/or tumor response in elderly patients with metastatic colorectal carcinoma
randomized to receive fluoropyrimidine-based therapy plus bevacizumab, with or without
oxaliplatin.
- To evaluate the association of tissue-based biomarkers (e.g., KRAS and BRAF status) and
outcome in elderly patients with metastatic colorectal carcinoma randomized to receive
fluoropyrimidine-based therapy plus bevacizumab, with or without oxaliplatin.
- To analyze pharmacokinetics and circulating biomarkers prior to and during therapy and
to assess these alterations with outcome in elderly patients with metastatic colorectal
carcinoma randomized to receive fluoropyrimidine-based therapy plus bevacizumab, with
or without oxaliplatin.
OUTLINE: This is a multicenter study. Patients are stratified according to age (≥ 85 years
vs 80-84 years vs 75-79 years vs 70-74 years), ECOG performance status (0-1 vs 2), and
number of metastatic sites (1 vs > 1). Patients are randomized to 1 of 2 treatment arms.
- Arm A: Patients are assigned to 1 of 2 treatment groups based on physician decision for
fluoropyrimidine.
- Arm A1: Patients receive fluorouracil IV over 46-48 hours, leucovorin calcium IV
over 2 hours, and bevacizumab IV over 10-90 minutes on day 1. Courses repeat every
14 days in the absence of disease progression or unacceptable toxicity.
- Arm A2: Patients receive capecitabine orally (PO) twice daily on days 1-14 and
bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
- Arm B: Patients are assigned to 1 of 2 treatment groups based on physician decision for
fluoropyrimidine.
- Arm B1: Patients receive mFOLFOX7 comprising oxaliplatin IV over 2 hours,
leucovorin calcium IV over 2 hours, and fluorouracil IV over 46-48 hours on day 1.
Patients also receive bevacizumab IV over 10-90 minutes on day 1. Courses repeat
every 14 days in the absence of disease progression or unacceptable toxicity.
- Arm B2: Patients receive XELOX comprising oxaliplatin IV over 2 hours on day 1 and
capecitabine PO twice daily on days 1-14. Patients also receive bevacizumab IV
over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
Patients may undergo blood and tissue sample collection at baseline and additional blood
sample collection during and after study for correlative biomarker, pharmacogenetic, and
pharmacological research studies.
Patients undergo neurotoxicity, quality of life, and geriatric/frailty assessments at
baseline and periodically during and after study treatment.
After completion of study treatment, patients are followed up periodically for 5 years.
DISEASE CHARACTERISTICS:
- Patients must have metastatic colorectal cancer that has been histologically or
cytologically confirmed
- Histologic confirmation can be obtained from the primary tumor with appropriate
imaging studies confirming metastatic spread
- No known central nervous system or brain metastasis that are either symptomatic or
untreated
- If a patient has a resection of the metastasis and is no longer symptomatic, the
patient is eligible for the study
- Patients with neurological symptoms must undergo a CT scan/MRI of the brain to
exclude brain metastasis
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2
- Life expectancy ≥ 3 months
- Absolute neutrophil count (ANC) ≥ 1,500/mm^3
- Peripheral platelet count (PLT) ≥ 100,000/mm^3
- Hemoglobin (HgB) > 9.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Aspartate transaminase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver
involvement)
- Alkaline phosphatase ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement)
- Creatinine ≤ 1.5 x ULN
- No calculated creatinine clearance < 60 mL/minute
- NOTE: If calculated creatinine clearance does not meet eligibility requirement,
a 24-hour urine can be collected for a creatinine clearance, and the patient can
be enrolled if measured creatinine clearance ≥ 60 mL/minute.
- INR < 1.5 x ULN unless patients are receiving anti-coagulation therapy
- Patients receiving prophylactic anti-coagulation therapy with an agent such as
warfarin or heparin are allowed to participate if INR ≤ 3.0
- UPC ratio < 1 or urine dipstick < 2+
- NOTE: Urine protein must be screened by urine analysis for urine protein
creatinine (UPC) ratio or by dipstick. For UPC ratio ≥ 1.0 or urine dipstick ≥
2+, 24-hour urine protein must be obtained and the level should be < 1,000 mg.
- No men of childbearing potential who are unwilling to employ adequate contraception
during and for 6 months after the last dose of bevacizumab
- Ability to complete questionnaire(s) by themselves or with assistance
- Willing to provide mandatory blood samples for correlative research purposes
- No co-morbid systemic illnesses or other severe concurrent disease that, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of the safety and
adverse events of the prescribed regimens
- No immunocompromised patients (other than that related to the use of corticosteroids)
including patients known to be HIV positive with CD4 < 100 cells/uL
- No uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study
requirements
- No other active malignancy ≤ 3 years prior to randomization EXCEPT for nonmelanotic
skin cancer or carcinoma-in-situ of the cervix
- No New York Heart Association (NYHA) classification III or IV congestive heart
failure
- No inadequately controlled hypertension (systolic blood pressure of > 150 mm Hg or
diastolic blood pressure > 100 mm Hg on anti-hypertensive medications)
- No significant traumatic injury ≤ 28 days prior to randomization
- No active or recent hemoptysis (≥ ½ teaspoon of bright red blood per episode) ≤ 30
days prior to randomization
- No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess ≤ 6 months prior to randomization
- No serious non-healing wound, active ulcer, or untreated bone fracture
- NOTE: Patients with fractures secondary to metastatic disease are eligible after
appropriate radiotherapy.
- No history of hypertensive crisis or hypertensive encephalopathy
- No patient that has experienced any arterial thromboembolic events including, but not
limited to:
- Myocardial infarction
- Stroke
- Transient ischemic attack (TIA)
- Cerebrovascular accident
- Unstable angina ≤ 6 months prior to randomization
- Congestive heart failure requiring use of ongoing maintenance therapy for
life-threatening ventricular arrhythmias
- No significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent
peripheral arterial thrombosis ≤ 6 months prior to randomization
- No evidence or history of bleeding diathesis (greater than normal risk of bleeding),
coagulopathy (in the absence of therapeutic anticoagulation), or hemorrhage/bleeding
event > grade 3 ≤ 4 weeks prior to randomization
- No known hypersensitivity to any of the components of 5-fluorouracil/leucovorin,
capecitabine, oxaliplatin, or bevacizumab
- No clinically significant peripheral neuropathy at the time of randomization (defined
in the NCI Common Terminology Criteria for Adverse Events [CTCAE] v4.0 as ≥ grade 2
neurosensory or neuromotor toxicity)
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiation therapy, immunotherapy, or biological therapy for
recurrent or metastatic colorectal cancer
- NOTE: Prior chemotherapy or radiotherapy is permitted if they had been
administered as adjuvant or neoadjuvant therapy and a complete surgical
resection of the original colorectal cancer had been achieved.
- No progressive disease ≤ 12 months of completing oxaliplatin-containing adjuvant
therapy
- No prior radiation to > 30% of the bone marrow at any time
- No major surgical procedures or open biopsy ≤ 28 days prior to randomization or
anticipation of need for elective or planned major surgical procedure during the
course of the study
- No core biopsy or other minor surgical procedures ≤ 7 days prior to randomization
- NOTE: Placement of a vascular access device is allowed.
- If there is a history of prior malignancy, patients must not be receiving other
specific treatment (other than hormonal therapy) for this prior cancer
- Not receiving any other investigational agent which would be considered as a
treatment for the primary neoplasm
- Patients receiving full-dose anticoagulants are eligible provided the patient has
been on a stable dose, for at least 2 weeks, of low molecular weight heparin or
warfarin and has an INR range 2-3
- No aspirin doses > 325 mg daily
We found this trial at
381
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McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
1.877.590.5995
![CCOP - Michigan Cancer Research Consortium](/wp-content/uploads/logos/ccop---michigan-cancer-research-consortium.jpg)
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
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Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
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5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(678) 843-7001
![Saint Joseph's Hospital of Atlanta](/wp-content/uploads/logos/saint-joseph-s-hospital-of-atlanta.png)
Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
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Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Aurora Presbyterian Hospital At The Medical Center of Aurora and Centennial Medical Plaza, we treat...
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St. Agnes Hospital Cancer Center Saint Agnes Hospital is leading Maryland in the battle against...
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Summa Barberton Hospital Summa Barberton Hospital is a full member of Summa Health System and...
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8111 South Emerson Avenue
Beech Grove, Indiana 46237
Beech Grove, Indiana 46237
(317) 528-5000
![St. Francis Hospital and Health Centers - Beech Grove Campus](/wp-content/uploads/logos/st-francis-hospital-and-health-centers---beech-grove-campus.jpg)
St. Francis Hospital and Health Centers - Beech Grove Campus A trusted leader in providing...
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720 E Rosser Ave
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
(701) 323-6741
![Medcenter One Hospital Cancer Care Center](/wp-content/uploads/logos/medcenter-one-hospital-cancer-care-center.jpg)
Medcenter One Hospital Cancer Care Center Sanford Health is an integrated health system headquartered in...
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Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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900 East Broadway
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
701.530.7000
![St. Alexius Medical Center Cancer Center](/wp-content/uploads/logos/st-alexius-medical-center-cancer-center.gif)
St. Alexius Medical Center Cancer Center Throughout the healing continuum we are dedicated to our...
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St. Joseph Medical Center Located in Bloomington, Illinois, OSF St. Joseph Medical Center is a...
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Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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1055 N Curtis Rd
Boise, Idaho 83706
Boise, Idaho 83706
(208) 367-2121
![Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center](/wp-content/uploads/logos/saint-alphonsus-cancer-care-center-at-saint-alphonsus-regional-medical-center.jpg)
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Saint Alphonsus Health System...
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44 Binney St
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 632-6364
![Dana-Farber/Brigham and Women's Cancer Center](/wp-content/uploads/logos/dana-farber-brigham-and-women-s-cancer-center.gif)
Dana-Farber/Brigham and Women's Cancer Center Boston's Brigham and Women's Hospital (BWH) is an international leader...
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Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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Wood County Oncology Center The Cancer Care Center at Wood County Hospital opened March 2014,...
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Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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Burbank, California 91505
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Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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Graham Hospital At Graham Hospital, we have a proud and rich history of serving the...
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Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
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701 10th St SE
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
(319) 365-4673
![Mercy Regional Cancer Center at Mercy Medical Center](/wp-content/uploads/logos/mercy-regional-cancer-center-at-mercy-medical-center.gif)
Mercy Regional Cancer Center at Mercy Medical Center Hall-Perrine Cancer Center is a part of...
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Cedar Rapids Oncology Associates Oncology Associates at Mercy Medical Center in Cedar Rapids (also known...
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Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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1801 West Taylor, Suite 1E
Chicago, Illinois 60612
Chicago, Illinois 60612
312.355.1625
![University of Illinois Cancer Center](/wp-content/uploads/logos/university-of-illinois-cancer-center.jpg)
University of Illinois Cancer Center The University of Illinois Cancer Center is dedicated to reducing...
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Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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Marshfield Clinic - Chippewa Center The 15,000 square foot Lake Hallie Center provides urgent care...
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Mercy Cancer Center - West Lakes When it comes to cancer care, there
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2222 N. Nevada Avenue
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
(719) 776-5000
![Penrose Cancer Center at Penrose Hospital](/wp-content/uploads/logos/penrose-cancer-center-at-penrose-hospital.png)
Penrose Cancer Center at Penrose Hospital Through a full range of clinical trials, genetic counseling,...
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John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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Doctors Hospital Nationally recognized for care quality and patient safety and satisfaction, Doctors Hospital is...
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CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
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Mount Carmel Health - West Hospital Located near downtown Columbus, Mount Carmel West is the...
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300 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(800) 293-5066
![The Ohio State University Comprehensive Cancer Center](/wp-content/uploads/logos/arthur-g-james-cancer-hospital-and-solove-research-institute-at-ohio-state-university-medical-center.jpg)
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center...
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11850 Blackfoot St. NW
Suite 130
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
763-236-0808
![Mercy and Unity Cancer Center at Mercy Hospital](/wp-content/uploads/logos/mercy-and-unity-cancer-center-at-mercy-hospital.jpg)
Mercy and Unity Cancer Center at Mercy Hospital The Virginia Piper Cancer Institute - Mercy...
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Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
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