- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00436332
S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma
A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features (ADENOBAC)
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
Primary
- Determine overall survival of patients with stage IIIB or IV bronchioloalveolar carcinoma (BAC) or adenocarcinoma with BAC features treated with erlotinib hydrochloride and bevacizumab.
Secondary
- Determine the progression-free survival of patients treated with this regimen.
- Compare, preliminarily, response as assessed by RECIST criteria vs response as assessed by a central computer-assisted image-analysis system in patients with measurable disease treated with this regimen.
- Assess the frequency and severity of toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 2 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
California
-
Antioch, California, Forente stater, 94531
- Kaiser Permanente - Deer Valley
-
Berkeley, California, Forente stater, 94704
- Alta Bates Summit Comprehensive Cancer Center
-
Burlingame, California, Forente stater, 94010
- Peninsula Medical Center
-
Fremont, California, Forente stater, 94538
- Kaiser Permanente - Fremont
-
Hayward, California, Forente stater, 94545
- Kaiser Permanente Medical Center - Hayward
-
Marysville, California, Forente stater, 95901
- Tibotec Therapeutics - Division of Ortho Biotech Products, LP
-
Oakland, California, Forente stater, 94611
- Kaiser Permanente Medical Center - Oakland
-
Pleasanton, California, Forente stater, 94588
- Valley Medical Oncology Consultants - Pleasanton
-
Redwood City, California, Forente stater, 94063
- Kaiser Permanente Medical Center - Redwood City
-
Richmond, California, Forente stater, 94801
- Kaiser Permanente Medical Center - Richmond
-
Roseville, California, Forente stater, 95661
- Kaiser Permanente Medical Center - Roseville
-
Sacramento, California, Forente stater, 95817
- University of California Davis Cancer Center
-
Sacramento, California, Forente stater, 95823
- South Sacramento Kaiser-Permanente Medical Center
-
Sacramento, California, Forente stater, 95825
- Kaiser Permanente Medical Center - Sacramento
-
San Francisco, California, Forente stater, 94115
- Kaiser Permanente Medical Center - San Francisco Geary Campus
-
San Francisco, California, Forente stater, 94118
- California Pacific Medical Center - California Campus
-
San Jose, California, Forente stater, 95119
- Kaiser Permanente Medical Center - Santa Teresa
-
San Rafael, California, Forente stater, 94903
- Sutter Health - Western Division Cancer Research Group
-
San Rafael, California, Forente stater, 94903
- Kaiser Foundation Hospital - San Rafael
-
Santa Clara, California, Forente stater, 95051
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
-
Santa Rosa, California, Forente stater, 95403
- Kaiser Permanente Medical Center - Santa Rosa
-
South San Francisco, California, Forente stater, 94080
- Kaiser Permanente Medical Center - South San Francisco
-
Stockton, California, Forente stater, 95210
- Kaiser Permanente Medical Facility - Stockton
-
Truckee, California, Forente stater, 96161
- Tahoe Forest Cancer Center
-
Vacaville, California, Forente stater, 95688
- Kaiser Permanente Medical Center - Vacaville
-
Vallejo, California, Forente stater, 94589
- Sutter Solano Medical Center
-
Vallejo, California, Forente stater, 94589
- Kaiser Permanente Medical Center - Vallejo
-
Walnut Creek, California, Forente stater, 94596
- Kaiser Permanente Medical Center - Walnut Creek
-
-
Connecticut
-
Hartford, Connecticut, Forente stater, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30309
- Piedmont Hospital
-
Atlanta, Georgia, Forente stater, 30342-1611
- Northside Hospital Cancer Center
-
Atlanta, Georgia, Forente stater, 30342-1701
- Saint Joseph's Hospital of Atlanta
-
Atlanta, Georgia, Forente stater, 30342
- CCOP - Atlanta Regional
-
Austell, Georgia, Forente stater, 30106
- WellStar Cobb Hospital
-
Columbus, Georgia, Forente stater, 31904
- John B. Amos Cancer Center
-
Decatur, Georgia, Forente stater, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
-
Fayetteville, Georgia, Forente stater, 30214
- Piedmont Fayette Hospital
-
Gainesville, Georgia, Forente stater, 30501
- Northeast Georgia Medical Center
-
Lawrenceville, Georgia, Forente stater, 30045
- Gwinnett Medical Center
-
Marietta, Georgia, Forente stater, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
-
Riverdale, Georgia, Forente stater, 30274-2600
- Southern Regional Medical Center
-
Rome, Georgia, Forente stater, 30165
- Harbin Clinic Cancer Center - Medical Oncology
-
-
Hawaii
-
Honolulu, Hawaii, Forente stater, 96819
- Kaiser Permanente - Moanalua Medical Center and Clinic
-
-
Illinois
-
Decatur, Illinois, Forente stater, 62526
- Decatur Memorial Hospital Cancer Care Institute
-
Maywood, Illinois, Forente stater, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
-
Springfield, Illinois, Forente stater, 62781-0001
- Regional Cancer Center at Memorial Medical Center
-
-
Kansas
-
Chanute, Kansas, Forente stater, 66720
- Cancer Center of Kansas, PA - Chanute
-
Dodge City, Kansas, Forente stater, 67801
- Cancer Center of Kansas, PA - Dodge City
-
El Dorado, Kansas, Forente stater, 67042
- Cancer Center of Kansas, PA - El Dorado
-
Fort Scott, Kansas, Forente stater, 66701
- Cancer Center of Kansas - Fort Scott
-
Independence, Kansas, Forente stater, 67301
- Cancer Center of Kansas-Independence
-
Kingman, Kansas, Forente stater, 67068
- Cancer Center of Kansas, PA - Kingman
-
Lawrence, Kansas, Forente stater, 66044
- Lawrence Memorial Hospital
-
Liberal, Kansas, Forente stater, 67901
- Cancer Center of Kansas, PA - Liberal
-
Newton, Kansas, Forente stater, 67114
- Cancer Center of Kansas, PA - Newton
-
Parsons, Kansas, Forente stater, 67357
- Cancer Center of Kansas, PA - Parsons
-
Pratt, Kansas, Forente stater, 67124
- Cancer Center of Kansas, PA - Pratt
-
Salina, Kansas, Forente stater, 67401
- Cancer Center of Kansas, PA - Salina
-
Salina, Kansas, Forente stater, 67401
- Tammy Walker Cancer Center at Salina Regional Health Center
-
Topeka, Kansas, Forente stater, 66606
- Cotton-O'Neil Cancer Center
-
Wellington, Kansas, Forente stater, 67152
- Cancer Center of Kansas, PA - Wellington
-
Wichita, Kansas, Forente stater, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
-
Wichita, Kansas, Forente stater, 67214
- Cancer Center of Kansas, PA - Wichita
-
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, 67208
- Associates in Womens Health, PA - North Review
-
Winfield, Kansas, Forente stater, 67156
- Cancer Center of Kansas, PA - Winfield
-
-
Kentucky
-
Lexington, Kentucky, Forente stater, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48106-0995
- Saint Joseph Mercy Cancer Center
-
Ann Arbor, Michigan, Forente stater, 48106
- CCOP - Michigan Cancer Research Consortium
-
Battle Creek, Michigan, Forente stater, 49017
- Battle Creek Health System Cancer Care Center
-
Big Rapids, Michigan, Forente stater, 49307
- Mecosta County Medical Center
-
Dearborn, Michigan, Forente stater, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
-
Flint, Michigan, Forente stater, 48503
- Hurley Medical Center
-
Flint, Michigan, Forente stater, 48503
- Genesys Hurley Cancer Institute
-
Grand Blanc, Michigan, Forente stater, 48439
- Genesys Regional Medical Center
-
Grand Rapids, Michigan, Forente stater, 49503
- Butterworth Hospital at Spectrum Health
-
Grand Rapids, Michigan, Forente stater, 49503
- CCOP - Grand Rapids
-
Grand Rapids, Michigan, Forente stater, 49503
- Lacks Cancer Center at Saint Mary's Health Care
-
Grosse Pointe Woods, Michigan, Forente stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Jackson, Michigan, Forente stater, 49201
- Foote Memorial Hospital
-
Lansing, Michigan, Forente stater, 48912-1811
- Sparrow Regional Cancer Center
-
Livonia, Michigan, Forente stater, 48154
- St. Mary Mercy Hospital
-
Muskegon, Michigan, Forente stater, 49443
- Mercy General Health Partners
-
Pontiac, Michigan, Forente stater, 48341-2985
- St. Joseph Mercy Oakland
-
Port Huron, Michigan, Forente stater, 48060
- Mercy Regional Cancer Center at Mercy Hospital
-
Saginaw, Michigan, Forente stater, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
-
Traverse City, Michigan, Forente stater, 49684
- Munson Medical Center
-
Warren, Michigan, Forente stater, 48093
- St. John Macomb Hospital
-
Wyoming, Michigan, Forente stater, 49519
- Metro Health Hospital
-
-
Montana
-
Billings, Montana, Forente stater, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, Forente stater, 59101
- St. Vincent Healthcare Cancer Care Services
-
Billings, Montana, Forente stater, 59107-7000
- Billings Clinic - Downtown
-
Billings, Montana, Forente stater, 59102
- Hematology-Oncology Centers of the Northern Rockies - Billings
-
Bozeman, Montana, Forente stater, 59715
- Bozeman Deaconess Cancer Center
-
Butte, Montana, Forente stater, 59701
- St. James Healthcare Cancer Care
-
Great Falls, Montana, Forente stater, 59405
- Great Falls Clinic - Main Facility
-
Great Falls, Montana, Forente stater, 59405-5309
- Big Sky Oncology
-
Great Falls, Montana, Forente stater, 59405
- Sletten Cancer Institute at Benefis Healthcare
-
Havre, Montana, Forente stater, 59501
- Northern Montana Hospital
-
Helena, Montana, Forente stater, 59601
- St. Peter's Hospital
-
Kalispell, Montana, Forente stater, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, Forente stater, 59901
- Glacier Oncology, PLLC
-
Kalispell, Montana, Forente stater, 59901
- Kalispell Medical Oncology at KRMC
-
Missoula, Montana, Forente stater, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
-
Missoula, Montana, Forente stater, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
-
North Carolina
-
Goldsboro, North Carolina, Forente stater, 27534
- Wayne Memorial Hospital, Incorporated
-
Hendersonville, North Carolina, Forente stater, 28791
- Pardee Memorial Hospital
-
-
Ohio
-
Bellefontaine, Ohio, Forente stater, 43311
- Mary Rutan Hospital
-
Chillicothe, Ohio, Forente stater, 45601
- Adena Regional Medical Center
-
Columbus, Ohio, Forente stater, 43214-3998
- Riverside Methodist Hospital Cancer Care
-
Columbus, Ohio, Forente stater, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, Forente stater, 43215
- CCOP - Columbus
-
Columbus, Ohio, Forente stater, 43215
- Grant Medical Center Cancer Care
-
Columbus, Ohio, Forente stater, 43228
- Doctors Hospital at Ohio Health
-
Delaware, Ohio, Forente stater, 43015
- Grady Memorial Hospital
-
Lancaster, Ohio, Forente stater, 43130
- Fairfield Medical Center
-
Marietta, Ohio, Forente stater, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Mount Vernon, Ohio, Forente stater, 43050
- Knox Community Hospital
-
Newark, Ohio, Forente stater, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Springfield, Ohio, Forente stater, 45505
- Community Hospital of Springfield and Clark County
-
Westerville, Ohio, Forente stater, 43081
- Mount Carmel St. Ann's Cancer Center
-
Zanesville, Ohio, Forente stater, 43701
- Genesis - Good Samaritan Hospital
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
-
Utah
-
American Fork, Utah, Forente stater, 84003
- American Fork Hospital
-
Cedar City, Utah, Forente stater, 84720
- Sandra L. Maxwell Cancer Center
-
Logan, Utah, Forente stater, 84321
- Logan Regional Hospital
-
Murray, Utah, Forente stater, 84157
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
-
Ogden, Utah, Forente stater, 84403
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
-
Provo, Utah, Forente stater, 84604
- Utah Valley Regional Medical Center - Provo
-
Saint George, Utah, Forente stater, 84770
- Dixie Regional Medical Center - East Campus
-
Salt Lake City, Utah, Forente stater, 84143
- LDS Hospital
-
Salt Lake City, Utah, Forente stater, 84106
- Utah Cancer Specialists at UCS Cancer Center
-
-
Washington
-
Bellingham, Washington, Forente stater, 98225
- St. Joseph Cancer Center
-
Bremerton, Washington, Forente stater, 98310
- Olympic Hematology and Oncology
-
Kennewick, Washington, Forente stater, 99336
- Columbia Basin Hematology
-
Mount Vernon, Washington, Forente stater, 98274
- Skagit Valley Hospital Cancer Care Center
-
Poulsbo, Washington, Forente stater, 98370
- Harrison Poulsbo Hematology and Onocology
-
Seattle, Washington, Forente stater, 98109
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Forente stater, 98104
- Harborview Medical Center
-
Seattle, Washington, Forente stater, 98104
- Minor and James Medical, PLLC
-
Seattle, Washington, Forente stater, 98112
- Group Health Central Hospital
-
Seattle, Washington, Forente stater, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
-
Seattle, Washington, Forente stater, 98195
- University Cancer Center at University of Washington Medical Center
-
Spokane, Washington, Forente stater, 99202
- Cancer Care Northwest - Spokane South
-
Spokane, Washington, Forente stater, 99218
- Evergreen Hematology and Oncology, PS
-
Wenatchee, Washington, Forente stater, 98801-2028
- Wenatchee Valley Medical Center
-
-
Wyoming
-
Sheridan, Wyoming, Forente stater, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Biopsy-proven* bronchioloalveolar carcinoma (BAC) or BAC variants (e.g., adenocarcinoma with BAC features, BAC with invasive adenocarcinoma) meeting the following criteria:
- Incompletely resected or unresectable disease
- No component of squamous cell carcinoma
Disease staged as 1 of the following:
- Stage IIIB disease (T4 [cytologically confirmed malignant pleural effusion OR pleural tumor foci that are separate from direct pleural invasion by the primary tumor], any N, M0)
Stage IV disease (any T, any N, M1 [distant metastases present])
- Recurrent disease in a separate lobe after prior resection within the past 5 years; multifocal lesions in > 1 lobe; or any disease that is recurrent after surgery or radiotherapy is considered stage IV disease
- Tumor may be multifocal or diffuse NOTE: *Cytology specimens, including bronchial brushing, washings, or fine needle aspiration specimens, alone are not acceptable for diagnosis
Measurable or nonmeasurable disease by chest CT scan
- Pleural effusions, ascites, and laboratory parameters are not acceptable as only evidence of disease
- Disease must be present outside field of prior radiotherapy OR a new lesion must be inside port
- Treated brain metastases allowed provided the patient is asymptomatic and do not require steroids
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin normal
- AST or AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases are present)
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
- Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1 g by 24-hour urine collection
- Willing to provide prior smoking history
- No hemoptysis ≥ ½ teaspoon within the past 28 days
- No clinical history of pulmonary or upper respiratory hemorrhage > grade 2 within the past 6 months or > grade 1 within the past 28 days
- No history of thromboses or hemorrhage, including hemorrhagic or thrombotic stroke, or other CNS bleeding
- No uncontrolled hypertension
- No serious nonhealing wound, ulcer, or bone fracture
No other prior malignancy except for any of the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer that is currently in complete remission
- Any other cancer from which the patient has been disease free for 5 years
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- At least 28 days since prior radiotherapy (14 days for palliative radiotherapy)
- At least 28 days since prior surgery (thoracic or other major surgeries)
- More than 7 days since prior fine-needle aspiration or core biopsy
- At least 28 days since prior systemic chemotherapy or biologic therapy
- No prior gefitinib hydrochloride, erlotinib hydrochloride, or bevacizumab
- No other prior anti-epidermal growth factor receptor or anti-vascular endothelial growth factor therapies
- Concurrent stable, therapeutic anticoagulation therapy allowed (i.e., warfarin or low molecular weight heparin), provided the patient has no history of bleeding complications on anticoagulation or an inability to establish a stable therapeutic regimen for anticoagulation
- No other concurrent anticancer therapy, including surgery, chemotherapy, hormone therapy, biologic therapy, or radiotherapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Erlotinib and Bevacizumab
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Overall Survival
Tidsramme: From date of registration to maximum of 3 years
|
From date of registration to maximum of 3 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free Survival
Tidsramme: From date of registration to maximum of 3 years
|
From date of registration to maximum of 3 years
|
|
|
Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease
Tidsramme: From date of registration to maximum of 3 years
|
Images for response assessed by the central computer-assisted image-analysis system were never collected.
|
From date of registration to maximum of 3 years
|
|
Frequency and Severity of Toxicities
Tidsramme: From date of registration to maximum of 3 years
|
From date of registration to maximum of 3 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- West HJ, Moon J, Hirsch FR, et al.: SWOG S0635 and S0636: Phase II trials in advanced-stage NSCLC of erlotinib (OSI-774) and bevacizumab in bronchioloalveolar carcinoma (BAC) and adenocarcinoma with BAC features (adenoBAC), and in never-smokers with primary NSCLC adenocarcinoma (adenoCa). [Abstract] J Clin Oncol 30 (Suppl 15): A-7517, 2012.
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 (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer etter histologisk type
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Adenokarsinom
- Karsinom
- Neoplasmer, kjertel og epitel
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Adenokarsinom i lungene
- Lungeneoplasmer
- Adenokarsinom, Bronchiolo-Alveolar
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Proteinkinasehemmere
- Erlotinib hydroklorid
- Bevacizumab
Andre studie-ID-numre
- CDR0000529756
- U10CA032102 (U.S. NIH-stipend/kontrakt)
- S0635 (Annen identifikator: SWOG)
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