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

PhaseTypeAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, Treatment18 and overCALGB 80702
NCI-2011-02050, CALGB/SWOG 80702, CALGB-SWOG C80702, CDR0000675693, NCT01150045

Trial Description

Summary

This randomized phase III trial studies 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. 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, by stopping them from dividing, or by stopping them from spreading. 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.

Further Study Information

PRIMARY OBJECTIVES:

I. To compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only (oxaliplatin, fluorouracil, and leucovorin calcium [FOLFOX]) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily.

SECONDARY OBJECTIVES:

I. 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.

II. 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.

III. 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.

IV. To assess toxicities of celecoxib as maintenance adjuvant therapy in patients with stage III colon cancer.

V. To assess differences in cardiovascular-specific events with celecoxib versus placebo in a population of stage III colon cancer survivors.

VI. 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.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM A: Patients receive oxaliplatin intravenously (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 placebo orally (PO) once daily (QD). Courses repeat every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive FOLFOX as in Arm A and celecoxib PO QD. Courses repeat every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.

ARM C: Patients receive FOLFOX and placebo as in Arm A. Courses repeat every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM D: Patients receive FOLFOX and celecoxib as in Arm B. 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.

After completion of study treatment, patients are followed up every 6 months for 6 years.

Eligibility Criteria

Inclusion Criteria:

Total bilirubin =< 1.5 x upper limit of normal in the absence of Gilbert’s disease; for patients with Gilbert’s syndrome: direct bilirubin =< 1.5 x upper limit of normal

Patients are ineligible if they plan on regular use of nonsteroidal anti-inflammatory drugs (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 wash out period is required

Granulocytes >= 1,500/uL

Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

No symptomatic pulmonary fibrosis or interstitial pneumonitis >= grade 2

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 prior allergic reaction or hypersensitivity to sulfonamides, celecoxib or NSAIDs

No known allergy to platinum compounds

No neurosensory or neuromotor toxicity >= grade 2 at the time of registration

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

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

No evidence of residual involved lymph node disease or metastatic disease at the time of registration

Node positive disease (N1 or N2) as designated in American Joint Committee on Cancer (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

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

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

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

Creatinine =< 1.5 x upper limit of normal

Platelet count >= 100,000/uL

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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Alliance for Clinical Trials in Oncology

  • National Cancer Institute
Jeffrey A. Meyerhardt, Principal Investigator

Trial Sites

U.S.A.

Delaware
Lewes

Beebe Medical Center

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Newark

Christiana Care Health System-Christiana Hospital

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Christiana Gynecologic Oncology LLC

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Delaware Clinical and Laboratory Physicians PA

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Helen F Graham Cancer Center

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Medical Oncology Hematology Consultants PA

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Regional Hematology and Oncology PA

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Rehoboth Beach

Beebe Health Campus

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Seaford

Nanticoke Memorial Hospital

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

Wilmington

Christiana Care Health System-Wilmington Hospital

Stephen Scott Grubbs
Ph: 302-733-6227

Stephen Scott Grubbs
Principal Investigator

District of Columbia
Washington

Kaiser Permanente-Capitol Hill Medical Center

Leon Christopher Hwang
Ph: 301-548-5743

Leon Christopher Hwang
Principal Investigator

Veterans Affairs Medical Center -Washington DC

Dalia A. Mobarek
Ph: 877-328-2621

Dalia A. Mobarek
Principal Investigator

Washington Hospital Center

John Lindsay Marshall
Ph: 202-444-0381

John Lindsay Marshall
Principal Investigator

Maryland
Baltimore

Greater Baltimore Medical Center

Marshall A. Levine
Ph: 443-849-3706

Marshall A. Levine
Principal Investigator

Kaiser Permanente-Woodlawn Medical Center

Leon Christopher Hwang
Ph: 301-548-5743

Leon Christopher Hwang
Principal Investigator

MedStar Franklin Square Medical Center/Weinberg Cancer Institute

John Lindsay Marshall
Ph: 202-444-0381

John Lindsay Marshall
Principal Investigator

Saint Agnes Hospital

Carole Brennan Miller
Ph: 410-368-2910

Carole Brennan Miller
Principal Investigator

Sinai Hospital of Baltimore

Mayer Gorbaty
Ph: 410-601-6120
Email: pridgely@lifebridgehealth.org

Mayer Gorbaty
Principal Investigator

The Union Memorial Hospital

John Lindsay Marshall
Ph: 202-444-0381

John Lindsay Marshall
Principal Investigator

Easton

The Memorial Hospital at Easton

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

Mary S. De Shields
Principal Investigator

Largo

Kaiser Permanente - Largo Medical Center

Leon Christopher Hwang
Ph: 301-548-5743

Leon Christopher Hwang
Principal Investigator

Silver Spring

Holy Cross Hospital

Cheryl A. Aylesworth
Ph: 301-896-2719
Email: Bsquiller@suburbanhospital.org

Cheryl A. Aylesworth
Principal Investigator

New Jersey
Camden

Cooper Hospital University Medical Center

Alexandre Hageboutros
Ph: 856-325-6757

Alexandre Hageboutros
Principal Investigator

East Orange

Veterans Adminstration New Jersey Health Care System

Victor Tsu-Shih Chang
Ph: 800-475-2336
Email: patricia.goyer@med.va.gov

Victor Tsu-Shih Chang
Principal Investigator

Egg Harbor Township

AtlantiCare Surgery Center

Vijay K. Sandilya
Ph: 609-748-7200

Vijay K. Sandilya
Principal Investigator

Hamilton

The Cancer Institute of New Jersey Hamilton

Rebecca A. Moss
Ph: 732-235-8675

Rebecca A. Moss
Principal Investigator

Livingston

Saint Barnabas Medical Center

Stuart P. Leitner
Ph: 973-322-2470

Stuart P. Leitner
Principal Investigator

Mount Holly

Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

Michael S. Entmacher
Ph: 888-847-8823

Michael S. Entmacher
Principal Investigator

New Brunswick

Rutgers Cancer Institute of New Jersey

Rebecca A. Moss
Ph: 732-235-8675

Rebecca A. Moss
Principal Investigator

Newark

Newark Beth Israel Medical Center

Lori Schleicher
Ph: 973-926-7230

Lori Schleicher
Principal Investigator

UMDNJ - New Jersey Medical School

Lillian F. Pliner
Ph: 732-235-8675

Lillian F. Pliner
Principal Investigator

Sewell

Kennedy Health Systems-Cancer Center

Trina A. Poretta
Ph: 888-847-8823

Trina A. Poretta
Principal Investigator

Somerville

Robert Wood Johnson University Hospital Somerset

Kathleen C. Toomey
Ph: 908-685-2481

Kathleen C. Toomey
Principal Investigator

Sparta

Sparta Cancer Treatment Center

Nancy L. Lewis
Ph: 215-955-6084

Nancy L. Lewis
Principal Investigator

Vineland

Inspira Medical Center Vineland

Carl J. Minniti
Ph: 856-641-7933

Carl J. Minniti
Principal Investigator

Voorhees

MD Anderson Cancer Center at Cooper-Voorhees

Alexandre Hageboutros
Ph: 856-325-6757

Alexandre Hageboutros
Principal Investigator

Virtua West Jersey Hospital Voorhees

Michael S. Entmacher
Ph: 888-847-8823

Michael S. Entmacher
Principal Investigator

Woodbury

Inspira Medical Center Woodbury

Carl J. Minniti
Ph: 856-641-7933

Carl J. Minniti
Principal Investigator

Pennsylvania
Abington

Abington Memorial Hospital

Willard G. Andrews
Ph: 215-481-2402

Willard G. Andrews
Principal Investigator

Allentown

Lehigh Valley Hospital-Cedar Crest

Philip M. Monteleone
Ph: 484-884-2201

Philip M. Monteleone
Principal Investigator

Bethlehem

Lehigh Valley Hospital - Muhlenberg

Philip M. Monteleone
Ph: 484-884-2201

Philip M. Monteleone
Principal Investigator

Saint Luke's University Hospital-Bethlehem Campus

Sanjiv Satyanarain Agarwala
Ph: 610-954-3582
Email: infolink@slhn.org

Sanjiv Satyanarain Agarwala
Principal Investigator

Bryn Mawr

Bryn Mawr Hospital

Albert S. DeNittis
Ph: 866-225-5654

Albert S. DeNittis
Principal Investigator

Danville

Geisinger Medical Center

Edward J. Gorak
Ph: 570-271-5251

Edward J. Gorak
Principal Investigator

Drexel Hill

Delaware County Memorial Hospital

Stephen A. Shore
Ph: 610-284-8237
Email: jolene.garney@crozer.org

Stephen A. Shore
Principal Investigator

Easton

Easton Hospital

Sonyo Shin
Ph: 610-250-4000

Sonyo Shin
Principal Investigator

Ephrata

Ephrata Cancer Center

Wilfred A. Layne
Ph: 717-738-4070

Wilfred A. Layne
Principal Investigator

Ephrata Community Hospital

Wilfred A. Layne
Ph: 717-738-4070

Wilfred A. Layne
Principal Investigator

Hanover

Cherry Tree Cancer Center

Wilfred A. Layne
Ph: 717-738-4070

Wilfred A. Layne
Principal Investigator

Harrisburg

PinnacleHealth Cancer Center-Community Campus

Robert Alan Gordon
Ph: 717-724-6765
Email: klitchfield@PINNACLEHEALTH.org

Robert Alan Gordon
Principal Investigator

Hazleton

Geisinger Medical Center-Cancer Center Hazleton

Edward J. Gorak
Ph: 570-271-5251

Edward J. Gorak
Principal Investigator

Lewisburg

Geisinger Medical Oncology at Evangelical Community Hospital

Edward J. Gorak
Ph: 570-271-5251

Edward J. Gorak
Principal Investigator

Norristown

Mercy Suburban Hospital and Cancer Center

Nancy L. Lewis
Ph: 215-955-6084

Nancy L. Lewis
Principal Investigator

Paoli

Paoli Memorial Hospital

Albert S. DeNittis
Ph: 866-225-5654

Albert S. DeNittis
Principal Investigator

Philadelphia

Albert Einstein Medical Center

John C. Leighton
Ph: 215-456-3880

John C. Leighton
Principal Investigator

Thomas Jefferson University Hospital

Nancy L. Lewis
Ph: 215-955-6084

Nancy L. Lewis
Principal Investigator

Phoenixville

Phoenixville Hospital

Carl W. Sharer
Ph: 610-983-1908

Carl W. Sharer
Principal Investigator

Pottstown

Pottstown Memorial Medical Center

Wei (Frank) Song
Ph: 610-327-7544

Wei (Frank) Song
Principal Investigator

Pottsville

Geisinger Medical Oncology-Pottsville

Edward J. Gorak
Ph: 570-271-5251

Edward J. Gorak
Principal Investigator

Scranton

Scranton Hematology Oncology

Martin Hyzinski
Ph: 570-558-3020

Martin Hyzinski
Principal Investigator

Sellersville

Grand View Hospital

Anthony J. Magdalinski
Ph: 215-453-4162
Email: PParsons@gvh.org

Anthony J. Magdalinski
Principal Investigator

Upland

Associates In Hematology Oncology PC-Upland

Nancy L. Lewis
Ph: 215-955-6084

Nancy L. Lewis
Principal Investigator

West Chester

Chester County Hospital

William Emil Luginbuhl
Ph: 610-431-5297

William Emil Luginbuhl
Principal Investigator

West Grove

Jennersville Regional Hospital

Nancy L. Lewis
Ph: 215-955-6084

Nancy L. Lewis
Principal Investigator

West Reading

Reading Hospital

Terrence Paul Cescon
Ph: 610-988-9323

Terrence Paul Cescon
Principal Investigator

Wilkes-Barre

Geisinger Wyoming Valley/Henry Cancer Center

Edward J. Gorak
Ph: 570-271-5251

Edward J. Gorak
Principal Investigator

Williamsport

Susquehanna Cancer Center

Warren Lewis Robinson
Ph: 800-598-4282

Warren Lewis Robinson
Principal Investigator

Wynnewood

Lankenau Medical Center

Albert S. DeNittis
Ph: 866-225-5654

Albert S. DeNittis
Principal Investigator

York

WellSpan Health-York Cancer Center

Wilfred A. Layne
Ph: 717-738-4070

Wilfred A. Layne
Principal Investigator

WellSpan Health-York Hospital

Wilfred A. Layne
Ph: 717-738-4070

Wilfred A. Layne
Principal Investigator

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01150045

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.