Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer
Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features
3 other identifiers
interventional
72
1 country
157
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 lung-cancer
Started Oct 2005
Typical duration for phase_2 lung-cancer
157 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2005
CompletedFirst Posted
Study publicly available on registry
February 8, 2005
CompletedStudy Start
First participant enrolled
October 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
January 4, 2013
CompletedJune 28, 2023
June 1, 2023
4.5 years
February 7, 2005
December 3, 2012
June 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (Proportion of Patients With Objective Response)
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.
Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years
Secondary Outcomes (4)
Overall Survival
Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years
Time to Progression
Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years
Overall Survival by Smoking Status
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
Time to Progression by Smoking Status
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
Study Arms (1)
Cetuximab
EXPERIMENTALCetuximab 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +9 more criteria
You may not qualify if:
- 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)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (157)
Aurora Presbyterian Hospital
Aurora, Colorado, 80012, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933, United States
St. Anthony Central Hospital
Denver, Colorado, 80204, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, 80218, United States
St. Joseph Hospital
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
CCOP - Colorado Cancer Research Program
Denver, Colorado, 80224-2522, United States
Swedish Medical Center
Englewood, Colorado, 80110, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, 81502, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, 80502, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
Boca Raton, Florida, 33486, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, 60504, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435, United States
Swedish-American Regional Cancer Center
Rockford, Illinois, 61104-2315, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, 62781-0001, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403, United States
Mercy Capitol Hospital
Des Moines, Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67042, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
Morton Hospital & Medical Center
Taunton, Massachusetts, 02780, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
Foote Memorial Hospital
Jackson, Michigan, 49201, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, 48144, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Community Cancer Center of Monroe
Monroe, Michigan, 48162, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, 48162, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601, United States
St. John Macomb Hospital
Warren, Michigan, 48093, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, 55355, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul, Minnesota, 55102, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, 55125, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, 55125, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, 08053, United States
Booker Cancer Center at Riverview Medical Center
Red Bank, New Jersey, 07701, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, 08043, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
Wood County Oncology Center
Bowling Green, Ohio, 43402, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, 44710-1799, United States
Hematology Oncology Center
Elyria, Ohio, 44035, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Northwest Ohio Oncology Center
Maumee, Ohio, 43537, United States
St. Luke's Hospital
Maumee, Ohio, 43537, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon, Ohio, 43616, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, 44870, United States
Flower Hospital Cancer Center
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43617, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, 43623, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, 18015, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
St. Joseph Medical Center
Reading, Pennsylvania, 19604, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
Scranton, Pennsylvania, 18510, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, 16801, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
CCOP - Main Line Health
Wynnewood, Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039, United States
CCOP - Scott and White Hospital
Temple, Texas, 76508, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401, United States
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, 54701, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, 54548, United States
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, 54501, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, 54868, United States
Saint Michael's Hospital Cancer Center
Stevens Point, Wisconsin, 54481, United States
Marshfield Clinic - Wausau Center
Wausau, Wisconsin, 54401, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, 54401, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Related Publications (1)
Ramalingam SS, Lee JW, Belani CP, Aisner SC, Kolesar J, Howe C, Velasco MR, Schiller JH. Cetuximab for the treatment of advanced bronchioloalveolar carcinoma (BAC): an Eastern Cooperative Oncology Group phase II study (ECOG 1504). J Clin Oncol. 2011 May 1;29(13):1709-14. doi: 10.1200/JCO.2010.33.4094. Epub 2011 Mar 21.
PMID: 21422434RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG Statistical Office
Study Officials
- STUDY CHAIR
Suresh Ramalingam, MD
Emory Winship Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2005
First Posted
February 8, 2005
Study Start
October 13, 2005
Primary Completion
April 1, 2010
Study Completion
August 1, 2012
Last Updated
June 28, 2023
Results First Posted
January 4, 2013
Record last verified: 2023-06