- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
-
-
-
-
Arizona
-
Scottsdale, Arizona, Forente stater, 85259
- Mayo Clinic Scottsdale
-
-
Colorado
-
Fort Collins, Colorado, Forente stater, 80524
- Front Range Cancer Specialists
-
-
Florida
-
Jacksonville, Florida, Forente stater, 32224
- Mayo Clinic - Jacksonville
-
-
Illinois
-
Aurora, Illinois, Forente stater, 60507
- Rush-Copley Cancer Care Center
-
Bloomington, Illinois, Forente stater, 61701
- St. Joseph Medical Center
-
Canton, Illinois, Forente stater, 61520
- Graham Hospital
-
Carthage, Illinois, Forente stater, 62321
- Memorial Hospital
-
Effingham, Illinois, Forente stater, 62401
- St. Anthony's Memorial Hospital
-
Eureka, Illinois, Forente stater, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, Forente stater, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, Forente stater, 61401
- Galesburg Clinic
-
Havana, Illinois, Forente stater, 62644
- Mason District Hospital
-
Hopedale, Illinois, Forente stater, 61747
- Hopedale Medical Complex
-
Joliet, Illinois, Forente stater, 60435
- Joliet Oncology Hematology Associates, Limited - West
-
Kewanee, Illinois, Forente stater, 61443
- Kewanee Hospital
-
Macomb, Illinois, Forente stater, 61455
- Mcdonough District Hospital
-
Normal, Illinois, Forente stater, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, Forente stater, 61761
- Community Cancer Center
-
Ottawa, Illinois, Forente stater, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, Forente stater, 61350
- Oncology Hematology Associates of Central Illinois - Ottawa
-
Pekin, Illinois, Forente stater, 61554
- Cancer Treatment Center at Pekin Hospital
-
Peoria, Illinois, Forente stater, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Forente stater, 61614
- Proctor Hospital
-
Peoria, Illinois, Forente stater, 61637
- OSF St. Francis Medical Center
-
Peoria, Illinois, Forente stater, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, Forente stater, 61615
- Oncology/Hematology Associates of Central Illinois, P.C.
-
Peru, Illinois, Forente stater, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, Forente stater, 61356
- Perry Memorial Hospital
-
Spring Valley, Illinois, Forente stater, 61362
- St. Margaret's Hospital
-
Urbana, Illinois, Forente stater, 61801
- Carle Cancer Center at Carle Foundation Hospital
-
Urbana, Illinois, Forente stater, 61801
- CCOP - Carle Cancer Center
-
-
Indiana
-
Beech Grove, Indiana, Forente stater, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Michigan City, Indiana, Forente stater, 46360
- Saint Anthony Memorial Health Centers
-
-
Iowa
-
Cedar Rapids, Iowa, Forente stater, 52402
- St. Luke's Hospital
-
Cedar Rapids, Iowa, Forente stater, 52403
- Cedar Rapids Oncology Associates
-
Cedar Rapids, Iowa, Forente stater, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
-
Des Moines, Iowa, Forente stater, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, Forente stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, Forente stater, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, Forente stater, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, Forente stater, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Forente stater, 50307
- Mercy Capitol Hospital
-
Des Moines, Iowa, Forente stater, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Sioux City, Iowa, Forente stater, 51101
- Siouxland Regional Cancer Center
-
Sioux City, Iowa, Forente stater, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, Forente stater, 51104
- Mercy Medical Center - Sioux City
-
Sioux City, Iowa, Forente stater, 51101
- Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
-
West Des Moines, Iowa, Forente stater, 50266
- Medical Oncology and Hematology Associates - West Des Moines
-
-
Kansas
-
Chanute, Kansas, Forente stater, 66720
- Cancer Center of Kansas, P.A. - Chanute
-
Dodge City, Kansas, Forente stater, 67801
- Cancer Center of Kansas, P.A. - Dodge City
-
El Dorado, Kansas, Forente stater, 67042
- Cancer Center of Kansas, P.A. - El Dorado
-
Kingman, Kansas, Forente stater, 67068
- Cancer Center of Kansas, P.A. - Kingman
-
Liberal, Kansas, Forente stater, 67901
- Southwest Medical Center
-
Newton, Kansas, Forente stater, 67114
- Cancer Center of Kansas, P.A. - Newton
-
Parsons, Kansas, Forente stater, 67357
- Cancer Center of Kansas, P.A. - Parsons
-
Pratt, Kansas, Forente stater, 67124
- Cancer Center of Kansas, P.A. - Pratt
-
Salina, Kansas, Forente stater, 67042
- Cancer Center of Kansas, P.A. - Salina
-
Wellington, Kansas, Forente stater, 67152
- Cancer Center of Kansas, P.A. - Wellington
-
Wichita, Kansas, Forente stater, 67214
- CCOP - Wichita
-
Wichita, Kansas, Forente stater, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
Wichita, Kansas, Forente stater, 67214
- Cancer Center of Kansas, P.A. - Wichita
-
Wichita, Kansas, Forente stater, 67203
- Associates in Womens Health, P.A. - North Review
-
Wichita, Kansas, Forente stater, 67208
- Cancer Center of Kansas, P.A. - Medical Arts Tower
-
Winfield, Kansas, Forente stater, 67156
- Cancer Center of Kansas, P.A. - Winfield
-
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Michigan
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Adrian, Michigan, Forente stater, 49221
- Hickman Cancer Center at Bixby Medical Center
-
Lambertville, Michigan, Forente stater, 48144
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
-
Monroe, Michigan, Forente stater, 48162
- Community Cancer Center of Monroe
-
Monroe, Michigan, Forente stater, 48162
- Mercy Memorial Hospital System
-
-
Minnesota
-
Alexandria, Minnesota, Forente stater, 56308
-
Bemidji, Minnesota, Forente stater, 56601
- MeritCare Clinic - Bemidji
-
Brainerd, Minnesota, Forente stater, 56401
- Brainerd Medical Center
-
Brainerd, Minnesota, Forente stater, 56401
- St. Joseph's Medical Center
-
Burnsville, Minnesota, Forente stater, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Forente stater, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
-
Edina, Minnesota, Forente stater, 55435
- Fairview Southdale Hospital
-
Fergus Falls, Minnesota, Forente stater, 56537
-
Fridley, Minnesota, Forente stater, 55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Hutchinson, Minnesota, Forente stater, 55350
- Hutchinson Area Health Care
-
Lichfield, Minnesota, Forente stater, 55355
- Meeker County Memorial Hospital
-
Maplewood, Minnesota, Forente stater, 55109
- St. John's Hospital
-
Minneapolis, Minnesota, Forente stater, 55415
- Hennepin County Medical Center - Minneapolis
-
Minneapolis, Minnesota, Forente stater, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Montevideo, Minnesota, Forente stater, 56265
- Chippewa County - Montevideo Hospital
-
Robbinsdale, Minnesota, Forente stater, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
-
Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
-
Saint Cloud, Minnesota, Forente stater, 56303
- Coborn Cancer Center
-
Saint Louis Park, Minnesota, Forente stater, 55416
- CCOP - Metro-Minnesota
-
Shakopee, Minnesota, Forente stater, 55379
- Saint Francis Cancer Center
-
St Paul, Minnesota, Forente stater, 55102
- St. Joseph's Hospital
-
St. Cloud, Minnesota, Forente stater, 56303
- CentraCare Clinic - River Campus
-
St. Louis Park, Minnesota, Forente stater, 55416
- Park Nicollet Health Services
-
St. Paul, Minnesota, Forente stater, 55102
- United Hospital
-
St. Paul, Minnesota, Forente stater, 55101
- Regions Hospital Cancer Care Center
-
Waconia, Minnesota, Forente stater, 55387
- Ridgeview Medical Center
-
Woodbury, Minnesota, Forente stater, 55125
- Woodwinds Health Campus
-
-
North Dakota
-
Bismarck, North Dakota, Forente stater, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Forente stater, 58501
- Cancer Care Center at Medcenter One Hospital
-
Bismarck, North Dakota, Forente stater, 58501
- Mid Dakota Clinic, P. C.
-
Bismarck, North Dakota, Forente stater, 58502
- St. Alexius Medical Center
-
Fargo, North Dakota, Forente stater, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Forente stater, 58122
- MeritCare Medical Group
-
Grand Forks, North Dakota, Forente stater, 58201
- Altru Cancer Center at Altru Hospital
-
-
Ohio
-
Bowling Green, Ohio, Forente stater, 43402
- Wood County Oncology Center
-
Dayton, Ohio, Forente stater, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, Forente stater, 45405
- Grandview Hospital
-
Dayton, Ohio, Forente stater, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Forente stater, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Forente stater, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Forente stater, 45429
- CCOP - Dayton
-
Findlay, Ohio, Forente stater, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, Forente stater, 43420
- Fremont Memorial Hospital
-
Kenton, Ohio, Forente stater, 43326
- Kenton Oncology, Incorporated
-
Kettering, Ohio, Forente stater, 45429
- Charles F. Kettering Memorial Hospital
-
Lima, Ohio, Forente stater, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, Forente stater, 43537
- Northwest Ohio Oncology Center
-
Maumee, Ohio, Forente stater, 43537
- St. Luke's Hospital
-
Middletown, Ohio, Forente stater, 45044
- Middletown Regional Hospital
-
Oregon, Ohio, Forente stater, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Forente stater, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, Forente stater, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, Forente stater, 44870
- North Coast Cancer Care, Incorporated
-
Sylvania, Ohio, Forente stater, 43560
- Promedica Cancer Center at Flower Hospital
-
Tiffin, Ohio, Forente stater, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Forente stater, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Forente stater, 43606
- Toledo Hospital
-
Toledo, Ohio, Forente stater, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Toledo, Ohio, Forente stater, 43623
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Forente stater, 43614
- Medical College of Ohio Cancer Institute
-
Toledo, Ohio, Forente stater, 43623
- Toledo Surgical Specialists
-
Troy, Ohio, Forente stater, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, Forente stater, 43567
- Fulton County Health Center
-
Xenia, Ohio, Forente stater, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, Forente stater, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Danville, Pennsylvania, Forente stater, 17822-0001
- Geisinger Medical Center
-
State College, Pennsylvania, Forente stater, 16801
- Geisinger Medical Group
-
Wilkes-Barre, Pennsylvania, Forente stater, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Dakota
-
Sioux Falls, South Dakota, Forente stater, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, Forente stater, 57105-1080
- Avera McKennan Hospital and University Health Center
-
Sioux Falls, South Dakota, Forente stater, 57105
- Medical X-Ray Center, P. C.
-
-
Wisconsin
-
La Crosse, Wisconsin, Forente stater, 54601
- Franciscan Skemp Healthcare
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Progression status at 6 months
Tidsramme: at 6 months
|
at 6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Progresjonsfri overlevelse
Tidsramme: Inntil 5 år
|
Inntil 5 år
|
|
Total overlevelse
Tidsramme: Inntil 5 år
|
Inntil 5 år
|
|
Confirmed response rate (complete or partial response)
Tidsramme: Up to 5 years
|
Up to 5 years
|
|
Quality of life as assessed by the Lung Cancer Symptom scale
Tidsramme: Up to 5 years
|
Up to 5 years
|
|
Social support measure as assessed by the Lubben Social Network scale
Tidsramme: Up to 5 years
|
Up to 5 years
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Antineoplastiske midler, fytogene
- Proteinkinasehemmere
- Karboplatin
- Paklitaksel
- Gefitinib
Andre studie-ID-numre
- NCCTG-N0222
- NCI-2012-02535 (Registeridentifikator: CTRP (Clinical Trials Reporting System))
- CDR0000304453 (Registeridentifikator: PDQ (Physician Data Query))
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