- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00062062
Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer
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
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with carboplatin and paclitaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gefitinib alone or together with carboplatin and paclitaxel works in treating older patients with unresectable or metastatic non-small cell lung cancer.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Arizona
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Scottsdale, Arizona, États-Unis, 85259
- Mayo Clinic Scottsdale
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Colorado
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Fort Collins, Colorado, États-Unis, 80524
- Front Range Cancer Specialists
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Florida
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Jacksonville, Florida, États-Unis, 32224
- Mayo Clinic - Jacksonville
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Illinois
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Aurora, Illinois, États-Unis, 60507
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, États-Unis, 61701
- St. Joseph Medical Center
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Canton, Illinois, États-Unis, 61520
- Graham Hospital
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Carthage, Illinois, États-Unis, 62321
- Memorial Hospital
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Effingham, Illinois, États-Unis, 62401
- St. Anthony's Memorial Hospital
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Eureka, Illinois, États-Unis, 61530
- Eureka Community Hospital
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Galesburg, Illinois, États-Unis, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, États-Unis, 61401
- Galesburg Clinic
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Havana, Illinois, États-Unis, 62644
- Mason District Hospital
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Hopedale, Illinois, États-Unis, 61747
- Hopedale Medical Complex
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Joliet, Illinois, États-Unis, 60435
- Joliet Oncology Hematology Associates, Limited - West
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Kewanee, Illinois, États-Unis, 61443
- Kewanee Hospital
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Macomb, Illinois, États-Unis, 61455
- Mcdonough District Hospital
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Normal, Illinois, États-Unis, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, États-Unis, 61761
- Community Cancer Center
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Ottawa, Illinois, États-Unis, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, États-Unis, 61350
- Oncology Hematology Associates of Central Illinois - Ottawa
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Pekin, Illinois, États-Unis, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, États-Unis, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, États-Unis, 61614
- Proctor Hospital
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Peoria, Illinois, États-Unis, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, États-Unis, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, États-Unis, 61615
- Oncology/Hematology Associates of Central Illinois, P.C.
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Peru, Illinois, États-Unis, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, États-Unis, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, États-Unis, 61362
- St. Margaret's Hospital
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Urbana, Illinois, États-Unis, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, États-Unis, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, États-Unis, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Michigan City, Indiana, États-Unis, 46360
- Saint Anthony Memorial Health Centers
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Iowa
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Cedar Rapids, Iowa, États-Unis, 52402
- St. Luke's Hospital
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Cedar Rapids, Iowa, États-Unis, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, États-Unis, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Des Moines, Iowa, États-Unis, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, États-Unis, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, États-Unis, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, États-Unis, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, États-Unis, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, États-Unis, 50307
- Mercy Capitol Hospital
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Des Moines, Iowa, États-Unis, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Sioux City, Iowa, États-Unis, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, États-Unis, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, États-Unis, 51104
- Mercy Medical Center - Sioux City
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Sioux City, Iowa, États-Unis, 51101
- Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
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West Des Moines, Iowa, États-Unis, 50266
- Medical Oncology and Hematology Associates - West Des Moines
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Kansas
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Chanute, Kansas, États-Unis, 66720
- Cancer Center of Kansas, P.A. - Chanute
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Dodge City, Kansas, États-Unis, 67801
- Cancer Center of Kansas, P.A. - Dodge City
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El Dorado, Kansas, États-Unis, 67042
- Cancer Center of Kansas, P.A. - El Dorado
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Kingman, Kansas, États-Unis, 67068
- Cancer Center of Kansas, P.A. - Kingman
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Liberal, Kansas, États-Unis, 67901
- Southwest Medical Center
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Newton, Kansas, États-Unis, 67114
- Cancer Center of Kansas, P.A. - Newton
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Parsons, Kansas, États-Unis, 67357
- Cancer Center of Kansas, P.A. - Parsons
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Pratt, Kansas, États-Unis, 67124
- Cancer Center of Kansas, P.A. - Pratt
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Salina, Kansas, États-Unis, 67042
- Cancer Center of Kansas, P.A. - Salina
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Wellington, Kansas, États-Unis, 67152
- Cancer Center of Kansas, P.A. - Wellington
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Wichita, Kansas, États-Unis, 67214
- CCOP - Wichita
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Wichita, Kansas, États-Unis, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, États-Unis, 67214
- Cancer Center of Kansas, P.A. - Wichita
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Wichita, Kansas, États-Unis, 67203
- Associates in Womens Health, P.A. - North Review
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Wichita, Kansas, États-Unis, 67208
- Cancer Center of Kansas, P.A. - Medical Arts Tower
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Winfield, Kansas, États-Unis, 67156
- Cancer Center of Kansas, P.A. - Winfield
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Michigan
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Adrian, Michigan, États-Unis, 49221
- Hickman Cancer Center at Bixby Medical Center
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Lambertville, Michigan, États-Unis, 48144
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
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Monroe, Michigan, États-Unis, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, États-Unis, 48162
- Mercy Memorial Hospital System
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Minnesota
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Alexandria, Minnesota, États-Unis, 56308
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Bemidji, Minnesota, États-Unis, 56601
- MeritCare Clinic - Bemidji
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Brainerd, Minnesota, États-Unis, 56401
- Brainerd Medical Center
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Brainerd, Minnesota, États-Unis, 56401
- St. Joseph's Medical Center
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Burnsville, Minnesota, États-Unis, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, États-Unis, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Edina, Minnesota, États-Unis, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, États-Unis, 56537
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Fridley, Minnesota, États-Unis, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, États-Unis, 55350
- Hutchinson Area Health Care
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Lichfield, Minnesota, États-Unis, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, États-Unis, 55109
- St. John's Hospital
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Minneapolis, Minnesota, États-Unis, 55415
- Hennepin County Medical Center - Minneapolis
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Minneapolis, Minnesota, États-Unis, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Montevideo, Minnesota, États-Unis, 56265
- Chippewa County - Montevideo Hospital
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Robbinsdale, Minnesota, États-Unis, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, États-Unis, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, États-Unis, 55416
- CCOP - Metro-Minnesota
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Shakopee, Minnesota, États-Unis, 55379
- Saint Francis Cancer Center
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St Paul, Minnesota, États-Unis, 55102
- St. Joseph's Hospital
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St. Cloud, Minnesota, États-Unis, 56303
- CentraCare Clinic - River Campus
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St. Louis Park, Minnesota, États-Unis, 55416
- Park Nicollet Health Services
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St. Paul, Minnesota, États-Unis, 55102
- United Hospital
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St. Paul, Minnesota, États-Unis, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, États-Unis, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, États-Unis, 55125
- Woodwinds Health Campus
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North Dakota
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Bismarck, North Dakota, États-Unis, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, États-Unis, 58501
- Cancer Care Center at Medcenter One Hospital
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Bismarck, North Dakota, États-Unis, 58501
- Mid Dakota Clinic, P. C.
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Bismarck, North Dakota, États-Unis, 58502
- St. Alexius Medical Center
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Fargo, North Dakota, États-Unis, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, États-Unis, 58122
- MeritCare Medical Group
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Grand Forks, North Dakota, États-Unis, 58201
- Altru Cancer Center at Altru Hospital
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Ohio
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Bowling Green, Ohio, États-Unis, 43402
- Wood County Oncology Center
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Dayton, Ohio, États-Unis, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, États-Unis, 45405
- Grandview Hospital
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Dayton, Ohio, États-Unis, 45406
- Good Samaritan Hospital
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Dayton, Ohio, États-Unis, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, États-Unis, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, États-Unis, 45429
- CCOP - Dayton
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Findlay, Ohio, États-Unis, 45840
- Blanchard Valley Medical Associates
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Fremont, Ohio, États-Unis, 43420
- Fremont Memorial Hospital
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Kenton, Ohio, États-Unis, 43326
- Kenton Oncology, Incorporated
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Kettering, Ohio, États-Unis, 45429
- Charles F. Kettering Memorial Hospital
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Lima, Ohio, États-Unis, 45804
- Lima Memorial Hospital
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Maumee, Ohio, États-Unis, 43537
- Northwest Ohio Oncology Center
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Maumee, Ohio, États-Unis, 43537
- St. Luke's Hospital
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Middletown, Ohio, États-Unis, 45044
- Middletown Regional Hospital
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Oregon, Ohio, États-Unis, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, États-Unis, 43616
- Toledo Clinic - Oregon
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Sandusky, Ohio, États-Unis, 44870
- Firelands Regional Medical Center
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Sandusky, Ohio, États-Unis, 44870
- North Coast Cancer Care, Incorporated
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Sylvania, Ohio, États-Unis, 43560
- Promedica Cancer Center at Flower Hospital
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Tiffin, Ohio, États-Unis, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, États-Unis, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, États-Unis, 43606
- Toledo Hospital
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Toledo, Ohio, États-Unis, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, États-Unis, 43623
- CCOP - Toledo Community Hospital
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Toledo, Ohio, États-Unis, 43614
- Medical College of Ohio Cancer Institute
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Toledo, Ohio, États-Unis, 43623
- Toledo Surgical Specialists
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Troy, Ohio, États-Unis, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wauseon, Ohio, États-Unis, 43567
- Fulton County Health Center
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Xenia, Ohio, États-Unis, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Pennsylvania
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Allentown, Pennsylvania, États-Unis, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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Danville, Pennsylvania, États-Unis, 17822-0001
- Geisinger Medical Center
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State College, Pennsylvania, États-Unis, 16801
- Geisinger Medical Group
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Wilkes-Barre, Pennsylvania, États-Unis, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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South Dakota
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Sioux Falls, South Dakota, États-Unis, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
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Sioux Falls, South Dakota, États-Unis, 57105-1080
- Avera McKennan Hospital and University Health Center
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Sioux Falls, South Dakota, États-Unis, 57105
- Medical X-Ray Center, P. C.
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Wisconsin
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La Crosse, Wisconsin, États-Unis, 54601
- Franciscan Skemp Healthcare
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Metastatic or unresectable disease
Measurable disease
- At least 1 lesion at least 2.0 cm
- Disease must be completely outside prior radiotherapy port OR documented disease progression since the completion of radiotherapy
- No meningeal carcinomatosis
No untreated brain metastases
- Current metastatic CNS disease must have been treated and clinically stable for at least 2 weeks prior to study chemotherapy
- No potentially curative treatment options available (e.g., chemotherapy with surgery or radiotherapy)
PATIENT CHARACTERISTICS:
Age
- 65 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10.0 g/dL
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- No uncontrolled hepatic disease
Renal
- Creatinine no greater than 2 times upper limit of normal
- No uncontrolled renal disease
Cardiovascular
- No uncontrolled cardiac disease
Pulmonary
No clinically active interstitial lung disease
- Asymptomatic, chronic stable radiographic changes allowed
- No uncontrolled respiratory disease
Other
- Fertile patients must use effective contraception
- Able and willing to complete questionnaires alone or with assistance
- No known hypersensitivity to gefitinib or any of its excipients
- No active infection within the past 2 weeks
- No other prior malignancy within the past 5 years except basal cell skin cancer
- No grade 2 or greater peripheral neuropathy (CTC v2.0)
- No uncontrolled diabetes mellitus (for patients receiving study chemotherapy)
- No dysphagia or inability to swallow intact capsules
- No significant medical condition that would preclude study treatment or follow-up
- No severe or uncontrolled systemic disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No prior chemotherapy for metastatic NSCLC
Endocrine therapy
- Concurrent steroids allowed provided the dose is not changed
Radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- No prior radiotherapy to more than 25% of marrow-containing skeleton
- No concurrent radiotherapy (including palliative)
Surgery
- See Disease Characteristics
- At least 3 weeks since prior major surgery
- No surgery within 7 days after study participation
Other
- More than 30 days since prior non-FDA approved investigational drugs
- No concurrent oral retinoids
No concurrent CYP3A4-inducing agents, including the following:
- Carbamazepine
- Oxcarbazepine
- Modafinil
- Ethosuximide
- Griseofulvin
- Nafcillin
- Phenobarbital
- Phenylbutazone
- Phenytoin
- Primidone
- Rifampin
- Hypericum perforatum (St. John's wort)
- Barbiturates
- Sulfinpyrazone
- No concurrent drugs that cause sustained elevation of gastric pH (≥ 5)
- No concurrent antacids within 4 hours before, during, and within 4 hours after gefitinib administration
- No concurrent itraconazole, fluconazole, ketoconazole, or erythromycin
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: gefitinib
Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after the completion of course 2. Patients are followed every 3 months for 5 years. |
|
Expérimental: paclitaxel + carboplatin + gefitinib
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Progression status at 6 months
Délai: at 6 months
|
at 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Survie sans progression
Délai: Jusqu'à 5 ans
|
Jusqu'à 5 ans
|
La survie globale
Délai: Jusqu'à 5 ans
|
Jusqu'à 5 ans
|
Confirmed response rate (complete or partial response)
Délai: Up to 5 years
|
Up to 5 years
|
Quality of life as assessed by the Lung Cancer Symptom scale
Délai: Up to 5 years
|
Up to 5 years
|
Social support measure as assessed by the Lubben Social Network scale
Délai: Up to 5 years
|
Up to 5 years
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques phytogéniques
- Inhibiteurs de protéine kinase
- Carboplatine
- Paclitaxel
- Géfitinib
Autres numéros d'identification d'étude
- NCCTG-N0222
- NCI-2012-02535 (Identificateur de registre: CTRP (Clinical Trials Reporting System))
- CDR0000304453 (Identificateur de registre: PDQ (Physician Data Query))
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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-
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