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
18 Years
N/A
Not Enrolling
Both
Lung Cancer
Both
Lung Cancer
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 Center | Seattle, Washington 98109 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| Keesler Medical Center - Keesler Air Force Base | Keesler AFB, Mississippi 39534-2576 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Sutter Cancer Center | Sacramento, California 95816 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| Great Falls Clinic | Great Falls, Montana 59405 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
| Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| St. Luke's Mountain States Tumor Institute - Boise | Boise, Idaho 83712-6297 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Spectrum Health Cancer Care - Butterworth Campus | Grand Rapids, Michigan 49503-2560 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| Greenville Hospital System Cancer Center | Greenville, South Carolina 29605 |
| Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
| Mecosta County General Hospital | Big Rapids, Michigan 49307 |
| Metropolitan Hospital | Grand Rapids, Michigan 49506 |
| Lacks Cancer Center at Saint Mary's Mercy Medical Center | Grand Rapids, Michigan 49503 |
| Holland Community Hospital | Holland, Michigan 49423 |
| Hackley Hospital | Muskegon, Michigan 49443 |
| Northern Michigan Hospital | Petoskey, Michigan 49770 |
| Munson Medical Center | Traverse City, Michigan 49684 |
| St. Francis Medical Center | Cape Girardeau, Missouri 63701 |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
| David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
| Big Sky Oncology | Great Falls, Montana 59405 |
| Sletten Regional Cancer Institute | Great Falls, Montana 59405 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| St. Joseph Hospital Community Cancer Center | Bellingham, Washington 98225 |
| Olympic Hematology and Oncology | Bremerton, Washington 98310 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
| Harborview Medical Center | Seattle, Washington 98104 |
| Group Health Central Hospital | Seattle, Washington 98104 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Central Washington Hospital | Wenatchee, Washington 98801 |
| Wenatchee Valley Clinic | Wenatchee, Washington 98801 |
| Josephine Ford Cancer Center at Henry Ford Health System | Detroit, Michigan 48202 |
| Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
| Summit Medical Center | Oakland, California 94609 |
| Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
| Peninsula Medical Center | Burlingame, California 94010 |
| Marin Cancer Institute at Marin General Hospital | Greenbrae, California 94904 |
| Saint Rose Hospital | Hayward, California 94545 |
| California Pacific Medical Center - California Campus | San Francisco, California 94118 |
| J.C. Robinson, M.D. Regional Cancer Center | San Pablo, California 94806 |
| Poudre Valley Hospital | Fort Collins, Colorado 80524 |
| Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
| Piedmont Hospital | Atlanta, Georgia 30309 |
| WellStar Cobb Hospital | Austell, Georgia 30106 |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
| Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
| Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
| Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
| Edward Hospital Cancer Center | Naperville, Illinois 60540 |
| Genesis Medical Center - West Campus | Davenport, Iowa 52804 |
| Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
| Salina Regional Health Center | Salina, Kansas 67401 |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
| Bay Regional Medical Center | Bay City, Michigan 48708 |
| Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
| Grandview Hospital | Dayton, Ohio 45405 |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
| Good Samaritan Hospital | Dayton, Ohio 45406 |
| Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
| Middletown Regional Hospital | Middletown, Ohio 45044 |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
| Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
| Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
| Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
| Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
| Providence St. Vincent Medical Center | Portland, Oregon 97225 |
| Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
| Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
| UMC Southwest Cancer and Research Center | Lubbock, Texas 79415-3364 |
| Danville Regional Medical Center | Danville, Virginia 24541 |
| Providence Cancer Center at Holy Family Hospital | Spokane, Washington 99207 |
| Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
| St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
| Montrose Memorial Hospital Cancer Center | Montrose, Colorado 81401 |
| St. Anthony North Hospital | Westminster, Colorado 80030 |
| Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
| Community Oncology Group - Independence | Independence, Ohio 44131 |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina 29621 |
| Alaska Regional Hospital | Anchorage, Alaska 99508 |
| Valley Memorial Hospital | Livermore, California 94550 |
| Highland General Hospital | Oakland, California 94602 |
| Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
| Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta, Georgia 31603 |
| St. Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
| Tulane Cancer Center | New Orleans, Louisiana 70112 |
| Spectrum Health Hospital - Blodgett Campus | Grand Rapids, Michigan 49506 |
| Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center | Portland, Oregon 97210 |
| Institute of Oncology at Vilnius University | Portland, Oregon 97227 |
| Salem Hospital Regional Cancer Center | Salem, Oregon 97309 |
| Cancer Care Center at Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
| St. Francis Medical Center | Honolulu, Hawaii 96817 |
| Tri-Health Good Samaritan Hospital | Cincinnati, Ohio 45220 |
| Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
| Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
| Rutherford Hospital | Rutherfordton, North Carolina 28139 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Cancer Care Center at Battle Creek Health System | Battle Creek, Michigan 49017 |
| MedCentral - Mansfield Hospital | Mansfield, Ohio 44903 |
| Sutter Roseville Medical Center | Roseville, California 95661 |
| Cancer Treatment Center at Christus Schumpert St. Mary Place | Shreveport, Louisiana 71101 |
| Freeman Cancer Institute at Freeman Health System | Joplin, Missouri 64803-2644 |
| St. Charles Medical Center | Bend, Oregon 97701 |
| McLeod Regional Medical Center | Florence, South Carolina 29501 |
| St. Joseph Mercy Hospital | Pontiac, Michigan 48341-2985 |
| Comprehensive Cancer Center at Desert Regional Medical Center | Palm Springs, California 92262 |
| Mercy General Hospital | Sacramento, California 95819 |
| Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
| Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
| Straub Clinic and Hospital, Incorporated | Honolulu, Hawaii 96813 |
| OnCare Hawaii, Incorporated - Kuakini | Honolulu, Hawaii 96817 |
| OnCare Hawaii, Incorporated - Lusitana | Honolulu, Hawaii 96813 |
| Valley Hospital - Ridgewood | Ridgewood, New Jersey 07450 |
| Hematology Oncology Consultants Ltd. | Naperville, Illinois 60540 |
| United States Air Force Medical Center Wright-Patterson | Wright-Patterson Afb, Ohio 45433-5529 |
| Washington Hematology - Oncology Specialists | Yakima, Washington 98902 |
| North Star Lodge Cancer Center | Yakima, Washington 98902 |
| Augusta Oncology Associates | Augusta, Georgia 30901 |
| Adirondack Cancer Care | Glens Falls, New York 12801 |
| Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia 24115-4788 |
| Arlington Cancer Center - Arlington | Arlington, Texas 76012 |
| Mount Clemens General Hospital | Mount Clemens, Michigan 48043 |
