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Phase II Selection Design Trial Of Concurrent Chemotherapy + Cetuximab Vs. Chemotherapy Followed By Cetuximab In Advanced Non-Small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Phase II Selection Design Trial Of Concurrent Chemotherapy + Cetuximab Vs. Chemotherapy Followed By Cetuximab In Advanced Non-Small Cell Lung Cancer (NSCLC)


OBJECTIVES:

Primary

- Compare overall survival of patients with selected stage IIIB or stage IV non-small
cell lung cancer treated with concurrent vs sequential paclitaxel, carboplatin, and
cetuximab.

Secondary

- Compare response rates (confirmed and unconfirmed, complete and partial) in patients
treated with these regimens.

- Compare the toxic effects of these regimens in these patients.

- Correlate epidermal growth factor receptor polymorphisms and downstream biomarkers with
response to cetuximab in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I (concurrent cetuximab): Patients receive cetuximab IV over 1 hour (over 2 hours
on day 1 of course 1 only) on days 1, 8, and 15 and paclitaxel IV over 3 hours and
carboplatin IV over 30 minutes on day 8. Treatment repeats every 21 days for a total of
4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity.
Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour once
weekly in the absence of disease progression or unacceptable toxicity.

- Arm II (sequential cetuximab): Patients receive paclitaxel IV over 3 hours and
carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a total of
4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity.
Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour (over 2
hours on week 13 only) once weekly in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this
study within 9 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of one
of the following stages:

- Newly diagnosed selected stage IIIB disease (T4 lesion due to malignant pleural
effusion, any N, M0)

- Newly diagnosed stage IV disease (any T, any N, M1)

- Recurrent stage IV disease after prior surgery or radiotherapy

- The following subtypes are eligible:

- Adenocarcinoma

- Squamous cell carcinoma

- Large cell carcinoma

- Unspecified

- Measurable disease by CT scan, MRI, x-ray, or physical exam

- Pleural effusions, ascites, or laboratory parameters are not acceptable as the
only evidence of disease

- Not within prior radiotherapy field unless a new lesion is present

- Not within area of prior surgical resection

- No known brain metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 mg/dL

Hepatic

- Bilirubin ≤ 2 times upper limit of normal (ULN)

- SGOT or SGPT ≤ 2 times ULN

- Alkaline phosphatase ≤ 2 times ULN

- No known acute hepatitis

Renal

- Creatinine ≤ ULN

- Creatinine clearance ≥ 50 mL/min

Cardiovascular

- No significant cardiac disease

- No uncontrolled hypertension

- No unstable angina

- No congestive heart failure

Other

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission

- No active or uncontrolled infection

- No sensory neuropathy ≥ grade 2

- No known human anti-mouse antibodies

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior biologic therapy for NSCLC

- No prior chimeric or murine monoclonal antibody therapy

- No prior cetuximab

Chemotherapy

- No prior systemic chemotherapy for NSCLC

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

Surgery

- See Disease Characteristics

- At least 2 weeks since prior thoracic or major surgery and recovered

Other

- No prior gefitinib or other investigational agents that target the epidermal growth
factor receptor pathway

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Select a regimen based on overall survival

Outcome Description:

To select a regimen based on overall survival via a Phase II selection design of chemotherapy in conjunction with cetuximab (concurrent vs. sequential) for Phase III testing against chemotherapy alone in Stage IIIB and Stage IV non-small cell lung cancer.

Outcome Time Frame:

From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years

Safety Issue:

No

Principal Investigator

Roy S. Herbst, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000370806

NCT ID:

NCT00085501

Start Date:

July 2004

Completion Date:

July 2011

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • squamous cell lung cancer
  • large cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Keesler Medical Center - Keesler Air Force BaseKeesler AFB, Mississippi  39534-2576
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Sutter Cancer CenterSacramento, California  95816
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Great Falls ClinicGreat Falls, Montana  59405
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
St. Luke's Mountain States Tumor Institute - BoiseBoise, Idaho  83712-6297
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Spectrum Health Cancer Care - Butterworth CampusGrand Rapids, Michigan  49503-2560
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Greenville Hospital System Cancer CenterGreenville, South Carolina  29605
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Mecosta County General HospitalBig Rapids, Michigan  49307
Metropolitan HospitalGrand Rapids, Michigan  49506
Lacks Cancer Center at Saint Mary's Mercy Medical CenterGrand Rapids, Michigan  49503
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Northern Michigan HospitalPetoskey, Michigan  49770
Munson Medical CenterTraverse City, Michigan  49684
St. Francis Medical CenterCape Girardeau, Missouri  63701
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Big Sky OncologyGreat Falls, Montana  59405
Sletten Regional Cancer InstituteGreat Falls, Montana  59405
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
St. Joseph Hospital Community Cancer CenterBellingham, Washington  98225
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Central Washington HospitalWenatchee, Washington  98801
Wenatchee Valley ClinicWenatchee, Washington  98801
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Summit Medical CenterOakland, California  94609
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Peninsula Medical CenterBurlingame, California  94010
Marin Cancer Institute at Marin General HospitalGreenbrae, California  94904
Saint Rose HospitalHayward, California  94545
California Pacific Medical Center - California CampusSan Francisco, California  94118
J.C. Robinson, M.D. Regional Cancer CenterSan Pablo, California  94806
Poudre Valley HospitalFort Collins, Colorado  80524
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
Edward Hospital Cancer CenterNaperville, Illinois  60540
Genesis Medical Center - West CampusDavenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Salina Regional Health CenterSalina, Kansas  67401
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
Bay Regional Medical CenterBay City, Michigan  48708
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Cleveland Clinic - WoosterWooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
UMC Southwest Cancer and Research CenterLubbock, Texas  79415-3364
Danville Regional Medical CenterDanville, Virginia  24541
Providence Cancer Center at Holy Family HospitalSpokane, Washington  99207
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
St. Anthony Central HospitalDenver, Colorado  80204-1335
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
St. Anthony North HospitalWestminster, Colorado  80030
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Community Oncology Group - IndependenceIndependence, Ohio  44131
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
Alaska Regional HospitalAnchorage, Alaska  99508
Valley Memorial HospitalLivermore, California  94550
Highland General HospitalOakland, California  94602
Northeast Georgia Medical CenterGainesville, Georgia  30501
Pearlman Comprehensive Cancer Center at South Georgia Medical CenterValdosta, Georgia  31603
St. Francis Hospital and Health CentersBeech Grove, Indiana  46107
Tulane Cancer CenterNew Orleans, Louisiana  70112
Spectrum Health Hospital - Blodgett CampusGrand Rapids, Michigan  49506
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical CenterPortland, Oregon  97210
Institute of Oncology at Vilnius UniversityPortland, Oregon  97227
Salem Hospital Regional Cancer CenterSalem, Oregon  97309
Cancer Care Center at Skagit Valley HospitalMt. Vernon, Washington  98273
St. Francis Medical CenterHonolulu, Hawaii  96817
Tri-Health Good Samaritan HospitalCincinnati, Ohio  45220
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Pardee Memorial HospitalHendersonville, North Carolina  28791
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Cancer Care Center at Battle Creek Health SystemBattle Creek, Michigan  49017
MedCentral - Mansfield HospitalMansfield, Ohio  44903
Sutter Roseville Medical CenterRoseville, California  95661
Cancer Treatment Center at Christus Schumpert St. Mary PlaceShreveport, Louisiana  71101
Freeman Cancer Institute at Freeman Health SystemJoplin, Missouri  64803-2644
St. Charles Medical CenterBend, Oregon  97701
McLeod Regional Medical CenterFlorence, South Carolina  29501
St. Joseph Mercy HospitalPontiac, Michigan  48341-2985
Comprehensive Cancer Center at Desert Regional Medical CenterPalm Springs, California  92262
Mercy General HospitalSacramento, California  95819
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Straub Clinic and Hospital, IncorporatedHonolulu, Hawaii  96813
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
Valley Hospital - RidgewoodRidgewood, New Jersey  07450
Hematology Oncology Consultants Ltd.Naperville, Illinois  60540
United States Air Force Medical Center Wright-PattersonWright-Patterson Afb, Ohio  45433-5529
Washington Hematology - Oncology SpecialistsYakima, Washington  98902
North Star Lodge Cancer CenterYakima, Washington  98902
Augusta Oncology AssociatesAugusta, Georgia  30901
Adirondack Cancer CareGlens Falls, New York  12801
Memorial Hospital of Martinsville and Henry CountyMartinsville, Virginia  24115-4788
Arlington Cancer Center - ArlingtonArlington, Texas  76012
Mount Clemens General HospitalMount Clemens, Michigan  48043