Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00103207
First received: February 7, 2005
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with recurrent or stage IIIB or stage IV lung cancer.


Condition Intervention Phase
Lung Cancer
Biological: cetuximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Objective Response Rate (Proportion of Patients With Objective Response) [ Time Frame: Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years ] [ Designated as safety issue: No ]
    Response was evaluated using RECIST 1.0 criteria. Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from registration to death.

  • Time to Progression [ Time Frame: Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years ] [ Designated as safety issue: No ]
    Time to progression is defined as time from study entry until disease progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.

  • Overall Survival by Smoking Status [ Time Frame: Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline ] [ Designated as safety issue: No ]
    Medians of overall survival by smoking status are reported.

  • Time to Progression by Smoking Status [ Time Frame: Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline ] [ Designated as safety issue: No ]
    Medians of time to progression by smoking status are reported.


Enrollment: 72
Study Start Date: August 2005
Study Completion Date: August 2012
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab
Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.
Biological: cetuximab
Other Name: C225

Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with recurrent or stage IIIB or IV bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features treated with cetuximab.

Secondary

  • Determine the overall survival and time to progression in patients treated with this drug.
  • Determine the toxic effects of this drug in these patients.
  • Correlate expression of total and phosphorylated epidermal growth factor receptor (EGFR), total and phosphorylated AKT3, and total and phosphorylated MAPKinase with response in patients treated with this drug.
  • Determine whether the presence of polymorphisms or mutations in the EGFR gene influences response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours once on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

ACTUAL ACCRUAL: A total of 72 patients were accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Histologically or cytologically confirmed bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features meeting 1 of the following stage criteria:

    • Stage IIIB disease (with pleural or pericardial effusion)
    • Stage IV disease
    • Recurrent disease
  • Measurable disease
  • Tumor tissue available from biopsy
  • Age of 18 and over
  • ECOG performance status of 0-2
  • Life expectancy greater than 3 months
  • White blood cell (WBC) ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin normal
  • Aspartate aminotransferase (AST) and/or alanine aminotranferease (ALT) ≤ 2.5 times upper limit of normal
  • Creatinine normal OR Creatinine clearance ≥ 60 mL/min
  • No more than 1 prior chemotherapy regimen for advanced BAC
  • More than 3 years since prior chemotherapy for other malignancies
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for this malignancy and recovered
  • HIV-positive patients are eligible provided the following criteria are met:

    • CD4 count ≥ 100/mm^3
    • Undetectable viral load within the past 3 months
    • Receiving a stable antiretroviral regimen for ≥ 4 weeks before study entry
  • Fertile patients must use effective contraception
  • At least 2 weeks since prior radiotherapy and recovered

EXCLUSION CRITERIA:

  • Untreated brain metastases

    • Patients with stable brain metastases ≥ 4 weeks after external beam radiotherapy to the brain are eligible
  • Acute hepatitis
  • Symptomatic congestive heart failure
  • Uncontrolled hypertension
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Pregnant or nursing
  • Prior allergic reaction to chimerized or murine monoclonal antibody therapy
  • Documented presence of human anti-mouse antibodies
  • Ongoing or active infection
  • Psychiatric illness or social situation that would preclude study compliance
  • Other uncontrolled illness
  • Prior cetuximab
  • Concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • Other prior known epidermal growth factor receptor inhibitors (e.g., gefitinib or erlotinib)
  • Other concurrent investigational agents
  • Other concurrent anticancer therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103207

  Hide Study Locations
Locations
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States, 80224-2522
Rose Medical Center
Denver, Colorado, United States, 80220
St. Joseph Hospital
Denver, Colorado, United States, 80218
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
St. Anthony Central Hospital
Denver, Colorado, United States, 80204
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Swedish Medical Center
Englewood, Colorado, United States, 80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80502
McKee Medical Center
Loveland, Colorado, United States, 80539
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
Boca Raton, Florida, United States, 33486
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Massachusetts
Morton Hospital & Medical Center
Taunton, Massachusetts, United States, 02780
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul, Minnesota, United States, 55102
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Booker Cancer Center at Riverview Medical Center
Red Bank, New Jersey, United States, 07701
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States, 44710-1799
Hematology Oncology Center
Elyria, Ohio, United States, 44035
Lima Memorial Hospital
Lima, Ohio, United States, 45804
St. Rita's Medical Center
Lima, Ohio, United States, 45801
St. Luke's Hospital
Maumee, Ohio, United States, 43537
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
Fulton County Health Center
Wauseon, Ohio, United States, 43567
United States, Pennsylvania
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
St. Joseph Medical Center
Reading, Pennsylvania, United States, 19604
Hematology and Oncology Associates of Northeastern Pennsylvania
Scranton, Pennsylvania, United States, 18510
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States, 19096
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
United States, Wisconsin
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States, 54701
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Saint Joseph's Hospital
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States, 54548
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States, 54868
Saint Michael's Hospital Cancer Center
Stevens Point, Wisconsin, United States, 54481
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
Marshfield Clinic - Wausau Center
Wausau, Wisconsin, United States, 54401
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Suresh Ramalingam, MD Emory Winship Cancer Institute
  More Information

Additional Information:
Publications:
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00103207     History of Changes
Other Study ID Numbers: CDR0000409755, U10CA021115, E1504
Study First Received: February 7, 2005
Results First Received: December 3, 2012
Last Updated: December 3, 2012
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
bronchioalveolar carcinoma (BAC)
adenocarcinoma with BAC features
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
cetuximab

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Bronchiolo-Alveolar
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014