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Clinical Trials (PDQ®)

Clinical Trials (PDQ®)

Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherCDR0000675693
CALGB-80702, CALGB-SWOG-C80702, NCT01150045

Trial Description

Summary

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.

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.

Further Study Information

OBJECTIVES:

Primary

  • To compare disease-free survival of patients with resected stage III colon cancer treated with adjuvant FOLFOX chemotherapy comprising oxaliplatin, fluorouracil, and leucovorin calcium with versus without celecoxib.

Secondary

  • To contribute to an international prospective pooled analysis comparing disease-free survival of patients treated with these regimens.
  • To compare overall survival at 3 years of patients treated with these regimens.
  • To contribute to an international prospective pooled analysis comparing disease-free survival of patients treated with 6 versus 12 courses of FOLFOX chemotherapy.
  • To assess toxicities of celecoxib as maintenance adjuvant therapy in these patients.
  • To assess differences in cardiovascular-specific events in patients treated with versus without celecoxib.
  • To evaluate differences in toxicities, particularly cumulative peripheral neuropathy, in patients treated with 6 versus 12 courses of FOLFOX chemotherapy.

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.

NOTE: *Patients with N1c-only disease (i.e., no positive nodes but N1c disease by AJCC 7) should be stratified to 1-3 nodes.

  • Arm I: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours (FOLFOX) on day 1. Patients also receive oral celecoxib once daily on days 1-14 beginning on day 1 of course 2 of FOLFOX. Courses repeat every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive FOLFOX as in arm I and oral placebo once daily on days 1-14 beginning on day 1 of course 2. Courses repeat every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.
  • Arm III: Patients receive FOLFOX and celecoxib as in arm I. Courses repeat every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm IV: Patients receive FOLFOX and placebo as in arm II. Courses repeat every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

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.

After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for years 2-3, and then annually for 3 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the colon
  • Stage III disease
  • The gross inferior (caudal) margin of the primary tumor must lie above the peritoneal reflection
  • No rectal cancer
  • Synchronous colon cancers allowed
  • No synchronous colon and rectal primary tumors
  • Completely resected tumor
  • Patients with adherent to adjacent structures, en bloc R_o resected tumor, must have it documented in the operative report
  • 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
  • Patients with resected stage IV disease are not eligible
  • 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)
  • No evidence of residual involved lymph node disease or metastatic disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Granulocyte count ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 8 weeks after completion of chemotherapy
  • No prior or concurrent malignancy except treated basal cell or squamous cell cancer of the skin, treated in situ cervical cancer, treated lobular or ductal carcinoma in situ in 1 breast, or any other cancer for which the patient has been disease-free for ≥ 5 years
  • No neurosensory or neuromotor toxicity ≥ grade 2
  • No known allergy to platinum compounds
  • No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib, or NSAIDs
  • "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
  • No symptomatic pulmonary fibrosis or interstitial pneumonitis ≥ grade 2
  • No cardiac risk factors including, but not limited to, any of the following:
  • Uncontrolled high BP (systolic BP > 150 mm Hg)
  • Unstable angina
  • History of documented myocardial infarction or cerebrovascular accident
  • NYHA class III-IV heart failure
  • :

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent NSAIDs ≥ 2 times per week on average or aspirin at > 325 mg ≥ 3 times per week on average
  • Low-dose aspirin not exceeding 100 mg/day allowed
  • Patients who agree to stop regular NSAIDs or higher-dose aspirin are eligble and no wash-out period is required

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

National Cancer Institute

Jeffrey A. MeyerhardtPrincipal Investigator

Trial Sites

U.S.A.
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Stephen Scott Grubbs Ph: 302-733-6227
  Newark
 Christiana Gynecologic Oncology, LLC
 Stephen Scott Grubbs Ph: 302-733-6227
 Delaware Clinical and Laboratory Physicians
 Stephen Scott Grubbs Ph: 302-733-6227
 Helen F. Graham Cancer Center at Christiana Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
 Stephen Scott Grubbs Ph: 302-733-6227
 Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center
 Stephen Scott Grubbs Ph: 302-733-6227
 Regional Hematology/Oncology, PA - Newark
 Stephen Scott Grubbs Ph: 302-733-6227
  Rehoboth Beach
 Beebe Health Campus
 Stephen Scott Grubbs Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
  Wilmington
 Christiana Care Health System-Wilmington Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
District of Columbia
  Washington
 Kaiser Permanente at Capitol Hill Medical Center
 Leon C. Hwang Ph: 301-816-7446
 Veterans Affairs Medical Center - Washington, DC
 Dalia A Mobarek Ph: 877-328-2621
 Washington Cancer Institute at Washington Hospital Center
 John L. Marshall Ph: 202-444-0381
Maryland
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Mayer Gorbaty Ph: 410-601-6120
  Email: pridgely@lifebridgehealth.org
 Kaiser Permanente at Woodlawn Medical Center
 Leon C. Hwang Ph: 301-816-7446
 St. Agnes Hospital Cancer Center
 Carole Miller Ph: 410-368-2910
  Easton
 Shore Regional Cancer Center at Memorial Hospital - Easton
 Mary S. DeShields Ph: 410-820-6800ext108
  Email: srichter@shorehealth.org
  Elkton MD
 Union Hospital of Cecil County
 Stephen Scott Grubbs Ph: 302-733-6227
  Largo
 Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
 Leon C. Hwang Ph: 301-816-7446
  Silver Spring
 Holy Cross Hospital
 Cheryl A. Aylesworth Ph: 301-896-2719
  Email: Bsquiller@suburbanhospital.org
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Alexandre Hageboutros Ph: 856-325-6757
  East Orange
 Veterans Affairs Medical Center - East Orange
 Basil S. Kasimis Ph: 800-475-2336
  Email: patricia.goyer@med.va.gov
  Egg Harbor Township
 AtlantiCare Surgery Center
 Vijay K Sandilya Ph: 609-748-7200
  Hamilton
 Cancer Institute of New Jersey at Hamilton
 Rebecca A Moss Ph: 732-235-8675
  Livingston
 St. Barnabas Medical Center Cancer Center
 Stuart P. Leitner Ph: 973-322-2470
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Michael S. Entmacher Ph: 888-847-8823
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Rebecca A Moss Ph: 732-235-8675
  Newark
 Newark Beth Israel Medical Center
 Lori Schleicher Ph: 973-926-7230
  Sewell
 Radiation Oncology Center at Kennedy Health System - Sewell
 Trina A Poretta Ph: 888-847-8823
  Sparta
 Frederick R. and Betty M. Smith Cancer Treatment Center
 Nancy Lewis Ph: 215-955-6084
  Vineland
 Frank and Edith Scarpa Regional Cancer Pavillion at South Jersey Healthcare
 Carl J. Minniti Ph: 856-641-7933
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Alexandre Hageboutros Ph: 856-325-6757
 Fox Chase Virtua Health Cancer Program at Virtua West Jersey
 Michael S. Entmacher Ph: 888-847-8823
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Willard G. Andrews Ph: 215-481-2402
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Eliot Lawrence Friedman Ph: 610-402-2273
  Bethlehem
 Lehigh Valley Hospital - Muhlenberg
 Eliot Lawrence Friedman Ph: 610-402-2273
 St. Luke's Cancer Network at St. Luke's Hospital
 Sanjiv S. Agarwala Ph: 610-954-3582
  Email: infolink@slhn.org
  Bryn Mawr
 Bryn Mawr Hospital
 Albert S DeNittis Ph: 866-225-5654
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Edward J Gorak Ph: 570-271-5251
  Doylestown
 Doylestown Hospital Cancer Center
 Mitchell Alden Ph: 215-345-2378
  Email: lheacock@dh.org
  Drexel Hill
 Delaware County Regional Cancer Center at Delaware County Memorial Hospital
 Stephen A. Shore Ph: 610-284-8237
  Email: jolene.garney@crozer.org
  Easton
 Easton Regional Cancer Center at Easton Hospital
 Sonyo Shin Ph: 610-250-4000
  Harrisburg
 PinnacleHealth Regional Cancer Center at Polyclinic Hospital
 Robert Alan Gordon Ph: 717-724-6765
  Email: klitchfield@PINNACLEHEALTH.org
  Hazleton
 Geisinger Hazleton Cancer Center
 Edward J Gorak Ph: 570-271-5251
  Lewisburg
 Geisinger Medical Oncology at Evangelical Community Hospital
 Edward J Gorak Ph: 570-271-5251
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
  Philadelphia
 Albert Einstein Cancer Center
 John Leighton Ph: 215-456-3880
 Fox Chase Cancer Center - Philadelphia
 Crystal S Denlinger Ph: 215-728-4790
 Frankford Hospital Cancer Center - Torresdale Campus
 Allen Lord Terzian Ph: 215-612-5296
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Nancy Lewis Ph: 215-955-6084
  Phoenixville
 Cancer Center at Phoenixville Hospital
 Carl W. Sharer Ph: 610-983-1908
  Pottsville
 Geisinger Medical Oncology-Pottsville
 Edward J Gorak Ph: 570-271-5251
  Scranton
 Scranton Hematology Oncology
 Martin B. Hyzinski Ph: 570-558-3020
  Sellersville
 Grand View Hospital
 Anthony J Magdalinski Ph: 215-453-4162
  Email: PParsons@gvh.org
  Upland
 Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
 Nancy Lewis Ph: 215-955-6084
  West Chester
 Cancer Center of Chester County
 William E. Luginbuhl Ph: 610-431-5297
  West Grove
 Jennersville Regional Hospital
 Nancy Lewis Ph: 215-955-6084
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Terrence P. Cescon Ph: 610-988-9323
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Edward J Gorak Ph: 570-271-5251
  Williamsport
 Susquehanna Cancer Center at Divine Providence Hospital
 Warren L Robinson Ph: 800-598-4282
  Wynnewood
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01150045
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.