Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery
Status: | Active, not recruiting |
---|---|
Conditions: | Colorectal Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/26/2019 |
Start Date: | June 2010 |
A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer
PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium,
and fluorouracil together to compare how well they work when given together with or without
celecoxib in treating patients with stage III colon cancer previously treated with surgery.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and
fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth. It is not yet known whether giving
oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib
in treating colon cancer.
and fluorouracil together to compare how well they work when given together with or without
celecoxib in treating patients with stage III colon cancer previously treated with surgery.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and
fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth. It is not yet known whether giving
oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib
in treating colon cancer.
OUTLINE: This is a multicenter study. Patients are stratified according to number of positive
lymph nodes* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs no).
Patients are randomized to 1 of 4 treatment arms. Please see the "Arms" section for more
information. In all arms, treatment with celecoxib or placebo continues for 3 years in the
absence of disease progression or unacceptable toxicity. Blood and tissue samples maybe
collected for biomarker analysis and pharmacogenomic studies. The primary and secondary
objectives for the research study are described below.
Primary objective:
1. To compare disease-free survival of patients with stage III colon cancer randomized to
standard chemotherapy only FOLFOX or standard chemotherapy FOLFOX with 3 years of celecoxib
400 mg daily.
Secondary objectives:
1. To contribute to an international prospective pooled analysis that will compare
disease-free survival of patients with stage III colon cancer randomized to 6 treatments
of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy.
2. To compare overall survival of patients with stage III colon cancer randomized to
standard chemotherapy only (FOLFOX) or standard chemotherapy (FOLFOX) with 3 years of
celecoxib 400 mg daily.
3. To contribute to an international prospective pooled analysis that will compare overall
survival of patients with stage III colon cancer randomized to 6 treatments of adjuvant
FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of
adjuvant FOLFOX chemotherapy.
4. To assess toxicities of celecoxib as maintenance adjuvant therapy in patients with stage
III colon cancer.
5. To assess differences in cardiovascular-specific events with celecoxib versus placebo in
a population of stage III colon cancer survivors.
6. To evaluate differences in toxicities, particularly cumulative peripheral neuropathy,
for patients treated with 6 treatments of FOLFOX compared to those treated with 12
treatments of FOLFOX.
After completion of study therapy, patients are followed up every 6 months for up to 6 years.
lymph nodes* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs no).
Patients are randomized to 1 of 4 treatment arms. Please see the "Arms" section for more
information. In all arms, treatment with celecoxib or placebo continues for 3 years in the
absence of disease progression or unacceptable toxicity. Blood and tissue samples maybe
collected for biomarker analysis and pharmacogenomic studies. The primary and secondary
objectives for the research study are described below.
Primary objective:
1. To compare disease-free survival of patients with stage III colon cancer randomized to
standard chemotherapy only FOLFOX or standard chemotherapy FOLFOX with 3 years of celecoxib
400 mg daily.
Secondary objectives:
1. To contribute to an international prospective pooled analysis that will compare
disease-free survival of patients with stage III colon cancer randomized to 6 treatments
of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy.
2. To compare overall survival of patients with stage III colon cancer randomized to
standard chemotherapy only (FOLFOX) or standard chemotherapy (FOLFOX) with 3 years of
celecoxib 400 mg daily.
3. To contribute to an international prospective pooled analysis that will compare overall
survival of patients with stage III colon cancer randomized to 6 treatments of adjuvant
FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of
adjuvant FOLFOX chemotherapy.
4. To assess toxicities of celecoxib as maintenance adjuvant therapy in patients with stage
III colon cancer.
5. To assess differences in cardiovascular-specific events with celecoxib versus placebo in
a population of stage III colon cancer survivors.
6. To evaluate differences in toxicities, particularly cumulative peripheral neuropathy,
for patients treated with 6 treatments of FOLFOX compared to those treated with 12
treatments of FOLFOX.
After completion of study therapy, patients are followed up every 6 months for up to 6 years.
1. Requirements for tumor parameters
1. Histologically documented adenocarcinoma of the colon. The gross inferior
(caudad) margin of the primary tumor must lie above the peritoneal reflection
(i.e., patients with rectal cancer are not eligible). Surgeon confirmation that
the entire tumor was above the peritoneal reflection is only required in cases
where it is important to establish if the tumor is a rectal or colon primary.
2. Tumors must have been completely resected. In patients with tumor adherent to
adjacent structures, en bloc R0 resection must be documented in the operative
report or otherwise confirmed by the surgeon. Near or positive radial margin are
not exclusions as long as en bloc resection was performed. Positive proximal
margin or distal margin is an exclusion.
3. Node positive disease (N1 or N2) as designated in AJCC version 7. Either at least
one pathologically confirmed positive lymph node or N1C (defined as tumor
deposit(s) in the subserosa, mesentery, or nonperitonealized pericolic or
perirectal tissues without regional lymph node metastases). Patients with
resected stage IV disease are not eligible.
4. No evidence of residual involved lymph node disease or metastatic disease at the
time of registration.
5. Patients with synchronous colon cancers are eligible and staging for
stratification will be based on higher N stage of the more advanced primary
tumor. However, patients with synchronous colon and rectal primary tumors are not
eligible.
2. NSAID use
Patients are ineligible if they plan on regular use of NSAIDs at any dose more than 2
times per week (on average) or aspirin at more than 325 mg at least three times per
week, on average. Low-dose aspirin not exceeding 100 mg/day is permitted. Patients who
agree to stop regular NSAIDs or higher dose aspirin are eligible and no was out period
is required.
3. Patient history
1. No previous or concurrent malignancy, except treated basal cell or squamous cell
cancer of skin, treated in situ cervical cancer, treated lobular or ductal
carcinoma in situ in one breast, or any other cancer for which the patient has
been disease-free for at least 5 years.
2. No neurosensory or neuromotor toxicity ≥ grade 2 at the time of registration.
3. No known allergy to platinum compounds.
4. No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib or
NSAIDs.
5. No history of upper gastrointestinal ulceration, upper gastrointestinal bleeding,
or upper gastrointestinal perforation within the past 3 years. Patients with
ulceration, bleeding or perforation in the lower bowel are not excluded.
6. No symptomatic pulmonary fibrosis or interstitial pneumonitis ≥ grade 2.
7. No cardiac risk factors including:
- Uncontrolled high blood pressure (systolic blood pressure > 150).
- Unstable angina.
- History of documented myocardial infarction or cerebrovascular accident.
- New York Heart Association class III or IV heart failure.
4. Pregancy/nursing status
Non-pregnant and not nursing. Men and women of childbearing potential must agree to
employ adequate contraception for the duration of chemotherapy and for as many as 8
weeks after the completion of chemotherapy due to the unknown teratogenic effects of
FOLFOX on the developing fetus.
5. Age and performance status
1. ECOG performance status 0, 1 or 2.
2. Age at least 18 years.
6. Required initial laboratory values
1. Granulocytes ≥ 1,500/μL
2. Platelet count ≥ 100,000/μL
3. Creatinine ≤ 1.5 times upper limit of normal (ULN)
4. Total Bilirubin ≤ 1.5 times ULN in the absence of Gilbert's disease
5. Direct bilirubin ≤ 1.5 x upper limit of normal for patients with Gilbert's
syndrome
We found this trial at
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Marietta Memorial Hospital We are 2,600 strong and the county
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
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361 Old Belgrade Road
Augusta, Maine 04330
Augusta, Maine 04330
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
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800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
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75 Francis street
Boston, Massachusetts 02115
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(617) 732-5500
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1 South Prospect Street
Burlington, Vermont 05401
Burlington, Vermont 05401
802-656-8990
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Chapel Hill, North Carolina 27599
(919) 962-2211
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1500 E Duarte Rd
Duarte, California 91010
Duarte, California 91010
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1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
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2500 N State St
Jackson, Mississippi 39216
Jackson, Mississippi 39216
(601) 984-1000
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Phone: 601-984-5080
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200 North Park Street
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
(269) 382-2500
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701 Doctors Dr
Kinston, North Carolina 28504
Kinston, North Carolina 28504
(252) 559-2200
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
(702) 383-2000
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Phone: 218-333-5000
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777 Hemlock Street
Macon, Georgia 31201
Macon, Georgia 31201
(478) 633-1000
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300 Community Drive
Manhasset, New York 11030
Manhasset, New York 11030
(516) 562-0100
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Phone: 516-734-8954
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305 1st Avenue # Dazian 7
New York, New York 10003
New York, New York 10003
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
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Phone: 503-216-6300
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
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593 Eddy Street
Providence, Rhode Island 02903
Providence, Rhode Island 02903
401-444-4000
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401 College Street
Richmond, Virginia 23298
Richmond, Virginia 23298
(804) 828-0450
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60 Crittenden Blvd # 70
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2121
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Phone: 585-275-4911
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
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34800 Bob Wilson Dr,
San Diego, California 92134
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825 Eastlake Ave E
Seattle, Washington 98109
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
Sioux Falls, South Dakota 57108
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601 South Sherman Street
Spokane, Washington 99202
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1200 Old York Road
Abington, Pennsylvania 19001
Abington, Pennsylvania 19001
(215) 481–2000
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1 Akron General Ave
Akron, Ohio 44307
Akron, Ohio 44307
(330) 344-6000
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Phone: 330-384-6505
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Albuquerque, New Mexico 87108
Phone: 505-272-5837
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1111 Duff Ave
Ames, Iowa 50010
Ames, Iowa 50010
(866) 972-5477
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2000 E Greenville St
Anderson, South Carolina 29621
Anderson, South Carolina 29621
(864) 512-4640
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5301 McAuley Drive
Ann Arbor, Michigan 48197
Ann Arbor, Michigan 48197
734-712-3456
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
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364 White Oak St
Asheboro, North Carolina 27203
Asheboro, North Carolina 27203
(336) 625-5151
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Auburn, California 95603
Phone: 408-730-2817
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1501 S Potomac St
Aurora, Colorado 80012
Aurora, Colorado 80012
(303) 695-2600
![Medical Center of Aurora](/wp-content/uploads/logos/medical-center-of-aurora.jpg)
Phone: 303-777-2663
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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13001 E. 17th Pl.
Aurora, Colorado 80045
Aurora, Colorado 80045
303-724-5000
![University of Colorado Cancer Center - Anschutz Cancer Pavilion](/wp-content/uploads/logos/university-of-colorado-cancer-center---anschutz-cancer-pavilion.png)
Phone: 303-724-3837
University of Colorado Cancer Center - Anschutz Cancer Pavilion The University of Colorado Denver |...
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2000 Ogden Ave
Aurora, Illinois 60504
Aurora, Illinois 60504
(630) 978-6200
![Rush - Copley Medical Center](/wp-content/uploads/logos/rush---copley-medical-center.png)
Phone: 217-383-3010
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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Bainbridge Island, Washington 98110
Phone: 253-530-8060
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2401 W Belvedere Ave
Baltimore, Maryland 21215
Baltimore, Maryland 21215
(410) 601-9000
![Sinai Hospital of Baltimore](/wp-content/uploads/logos/sinai-hospital-of-baltimore.jpg)
Phone: 410-701-4466
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Baltimore, Maryland 21237
Phone: 202-444-7064
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Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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Summa Barberton Hospital Summa Barberton Hospital is a full member of Summa Health System and...
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4950 Essen Ln
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
(225) 767-0847
![Mary Bird Perkins Cancer Center - Baton Rouge](/wp-content/uploads/logos/mary-bird-perkins-cancer-center---baton-rouge.jpg)
Phone: 504-210-2828
Mary Bird Perkins Cancer Center - Baton Rouge Mary Bird Perkins Cancer Center (MBPCC) and...
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Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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800 Farson Street
Belpre, Ohio 45714
Belpre, Ohio 45714
(740) 401-0417
![Strecker Cancer Center-Belpre](/wp-content/uploads/logos/strecker-cancer-center-belpre.jpg)
Phone: 614-488-2118
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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1351 Kimberly Rd
Bettendorf, Iowa 52722
Bettendorf, Iowa 52722
(563) 355-7733
![Hematology Oncology Associates of the Quad Cities](/wp-content/uploads/logos/hematology-oncology-associates-of-the-quad-cities.jpg)
Phone: 563-355-7733
Hematology Oncology Associates of the Quad Cities
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1233 North 30th Street
Billings, Montana 59101
Billings, Montana 59101
406-237-7000
![Saint Vincent Healthcare](/wp-content/uploads/logos/saint-vincent-healthcare.png)
Phone: 406-238-6290
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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300 N. Seventh St.
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
(701) 323-6000
![Sanford Bismarck Medical Center](/wp-content/uploads/logos/sanford-bismarck-medical-center.jpg)
Phone: 701-234-6161
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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1505 Eastland Drive
Bloomington, Illinois 61701
Bloomington, Illinois 61701
309-662-2102
![Illinois CancerCare-Bloomington](/wp-content/uploads/logos/illinois-cancercare-bloomington.gif)
Phone: 217-876-6600
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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100 E Idaho St
Boise, Idaho 83712
Boise, Idaho 83712
(208) 381-2711
![Saint Luke's Mountain States Tumor Institute](/wp-content/uploads/logos/saint-luke-s-mountain-states-tumor-institute.gif)
Phone: 208-381-2711
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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1501 North Oakland Drive
Bolivar, Missouri 65613
Bolivar, Missouri 65613
417-326-7200
![Central Care Cancer Center at Carrie J. Babb Cancer Center](/wp-content/uploads/logos/central-care-cancer-center-at-carrie-j-babb-cancer-center.png)
Phone: 417-820-3554
Central Care Cancer Center at Carrie J. Babb Cancer Center Cancer treatment often requires a...
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55 Fruit St
Boston, Massachusetts 02114
Boston, Massachusetts 02114
(617) 724-4000
![Massachusetts General Hospital Cancer Center](/wp-content/uploads/logos/massachusetts-general-hospital-cancer-center.jpg)
Phone: 617-632-6855
Massachusetts General Hospital Cancer Center An integral part of one of the world
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