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

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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. Meyerhardt, Principal 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: 301-548-5743

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

Greater Baltimore Medical Center Cancer Center

Marshall A. Levine
Ph: 443-849-3706

Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

John L. Marshall
Ph: 202-444-0381

Kaiser Permanente at Woodlawn Medical Center

Leon C. Hwang
Ph: 301-548-5743

St. Agnes Hospital Cancer Center

Carole Miller
Ph: 410-368-2910

Union Memorial Hospital

John L. Marshall
Ph: 202-444-0381

Easton

Shore Regional Cancer Center at Memorial Hospital - Easton

Mary S. DeShields
Ph: 410-820-6800ext108
Email: srichter@shorehealth.org

Largo

Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility

Leon C. Hwang
Ph: 301-548-5743

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

Victor T Chang
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

Morristown

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Michael Joel Kane
Ph: 609-748-7200

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

Somerville

Somerset Medical Center

Kathleen C Toomey
Ph: 908-685-2481

Sparta

Frederick R. and Betty M. Smith Cancer Treatment Center

Nancy Lewis
Ph: 215-955-6084

Summit

Overlook Hospital

Michael Joel Kane
Ph: 609-748-7200

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

Woodbury

Underwood Memorial Hospital

Carl J. Minniti
Ph: 856-641-7933

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

Philip M Monteleone
Ph: 484-884-2201

Bethlehem

Lehigh Valley Hospital - Muhlenberg

Philip M Monteleone
Ph: 484-884-2201

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

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

Ephrata

Ephrata Cancer Center at Ephrata Community Hospital

Wilfred A Layne
Ph: 717-738-4070

Wilfred A Layne
Ph: 717-738-4070

Hanover

Cherry Tree Cancer Center

Wilfred A Layne
Ph: 717-738-4070

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

Norristown

Norristown Regional Cancer Center

Nancy Lewis
Ph: 215-955-6084

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

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

Pottstown

Pottstown Memorial Regional Cancer Center

Wei Song
Ph: 610-327-7544

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

York

WellSpan Health

Wilfred A Layne
Ph: 717-738-4070

York Cancer Center at Apple Hill Medical Center

Wilfred A Layne
Ph: 717-738-4070

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01150045
ClinicalTrials.gov processed this data on April 09, 2015

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.