Parallel Phase II Trials of ZD1839 (Iressa) Alone or Weekly Carboplatin and Paclitaxel Followed by ZD1839 (Iressa) (Oncologists Must Choose) for Metastatic Non-Small Cell Lung Cancer in Patients > or = 65 Years of Age
OBJECTIVES:
Primary
- Determine the 6-month progression status of older patients with unresectable or
metastatic non-small cell lung cancer treated with gefitinib alone or with carboplatin
and paclitaxel.
Secondary
- Determine the response rate in patients treated with these regimens.
- Determine the quality of life of patients treated with these regimens.
- Determine whether serum-secreted or soluble epidermal growth factor receptor (EGFR)
concentrations predict response in patients treated with these regimens.
- Correlate the presence of social support for these patients with toxicity and efficacy
of these regimens.
- Determine whether social support for these patients differs according to gender.
- Determine the reasons an oncologist would choose a chemotherapy vs a nonchemotherapy
regimen for these patients.
Tertiary
- Correlate EGFR signaling pathway markers, RNA expression profile, gene polymorphisms of
prespecified germline and tumor genes, and plasma and urine proteomic patterns with
response rate and time to progression of patients receiving treatment in group I.
OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2
treatment groups as determined by their treating physician.
- Group I: Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
- Group II: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes
on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the
absence of disease progression or unacceptable toxicity. After completion of
chemotherapy and in the absence of disease progression, patients receive oral gefitinib
as in group I.
Quality of life is assessed at baseline and after the completion of course 2.
Patients are followed every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 107 patients (51 for group I and 56 for group II) will be
accrued for this study within 1.7 years.
Interventional
Allocation: Non-Randomized, Primary Purpose: Treatment
Progression status at 6 months
No
Aminah Jatoi, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000304453
NCT00062062
October 2004
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Toledo Hospital | Toledo, Ohio 43606 |
Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
Cancer Center of Kansas, P.A. - El Dorado | El Dorado, Kansas 67042 |
Southwest Medical Center | Liberal, Kansas 67901 |
Cancer Center of Kansas, P.A. - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, P.A. - Wichita | Wichita, Kansas 67214 |
Avera McKennan Hospital and University Health Center | Sioux Falls, South Dakota 57105 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Center of Kansas, P.A. - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, P.A. - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, P.A. - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, P.A. - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, P.A. - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas, P.A. - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, P.A. - Medical Arts Tower | Wichita, Kansas 67208 |
Associates in Womens Health, P.A. - North Review | Wichita, Kansas 67203 |
Cancer Center of Kansas, P.A. - Winfield | Winfield, Kansas 67156 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Haematology-Oncology Associates of Ohio and Michigan, P.C. | Lambertville, Michigan 48144 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Mercy Memorial Hospital System | Monroe, Michigan 48162 |
Alexandria, Minnesota 56308 | |
MeritCare Clinic - Bemidji | Bemidji, Minnesota 56601 |
Brainerd Medical Center | Brainerd, Minnesota 56401 |
St. Joseph's Medical Center | Brainerd, Minnesota 56401 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Chippewa County - Montevideo Hospital | Montevideo, Minnesota 56265 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
Cancer Care Center at Medcenter One Hospital | Bismarck, North Dakota 58501 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center | Bismarck, North Dakota 58502 |
Mid Dakota Clinic, P. C. | Bismarck, North Dakota 58501 |
MeritCare Medical Group | Fargo, North Dakota 58122 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
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 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Fremont Memorial Hospital | Fremont, Ohio 43420 |
Kenton Oncology, Incorporated | Kenton, Ohio 43326 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Lima Memorial Hospital | Lima, Ohio 45804 |
St. Luke's Hospital | Maumee, Ohio 43537 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
Toledo Clinic - Oregon | Oregon, Ohio 43616 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
Firelands Regional Medical Center | Sandusky, Ohio 44870 |
Promedica Cancer Center at Flower Hospital | Sylvania, Ohio 43560 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
Toledo Surgical Specialists | Toledo, Ohio 43623 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Joliet Oncology Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Oncology Hematology Associates of Central Illinois - Ottawa | Ottawa, Illinois 61350 |
St. Anthony's Memorial Hospital | Effingham, Illinois 62401 |
St. John's Hospital | Maplewood, Minnesota 55109 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Franciscan Skemp Healthcare | La Crosse, Wisconsin 54601-4796 |
Saint Francis Cancer Center | Shakopee, Minnesota 55379 |
St. Joseph's Hospital | St Paul, Minnesota 55102 |
Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
Medical College of Ohio Cancer Institute | Toledo, Ohio 43614 |
Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Cancer Center of Kansas, P.A. - Dodge City | Dodge City, Kansas 67801 |
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center | Sioux City, Iowa 51101 |
Medical X-Ray Center, P. C. | Sioux Falls, South Dakota 57105 |