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A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (RHUMAB VEGF; NSC 704865) in Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (RHUMAB VEGF; NSC 704865) in Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas


OBJECTIVES:

Primary

- Assess overall survival of patients with stage IIIB or IV primary non-small cell lung
adenocarcinoma who have never smoked and are treated with erlotinib hydrochloride and
bevacizumab.

Secondary

- Assess progression-free survival of patients treated with this regimen.

- Assess the response rate (confirmed and unconfirmed, complete and partial) in a subset
of patients with measurable disease treated with this regimen.

- Evaluate the frequency and severity of toxicities associated with this regimen in these
patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride 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 periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Adenocarcinoma

- No component of squamous cell carcinoma present

- Incompletely resected or unresectable disease

- Stage IIIB or IV disease as defined below:

- Selected 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 lung cancer in a separate lobe after resection or radiotherapy
within the past 5 years OR multifocal lesions in > 1 lobe considered stage
IV disease

- New lesions occurring ≥ 5 years after resection may be considered a separate primary
cancer and are not allowed if this is the only focus of lung cancer

- Measurable and/or nonmeasurable disease by CT scan, positron emission tomography
scan, or MRI

- Disease must be present outside a previous radiotherapy field OR a new lesion
must be inside the port

- Measurable disease must be assessed within the past 28 days

- Nonmeasurable disease must be assessed within the past 42 days

- Pleural effusions, ascites, and laboratory parameters are not acceptable as the
only evidence of disease

- Must be a lifelong nonsmoker (< 100 cigarettes in lifetime)

- 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/mm^3

- Platelet count ≥ 100,000/mm^3

- Total bilirubin normal

- SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases
present)

- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present)

- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min

- Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine
collection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Hypertension allowed if controlled on medication prior to study enrollment

- Must be willing to provide prior smoking history

- No immediate life-threatening complications from malignancies

- No prior major medical condition, psychological condition, or social situation that
would preclude study treatment

- 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 either thrombosis or hemorrhage, including hemorrhagic or thrombotic
stroke, or other CNS bleeding

- No serious nonhealing wound, ulcer, or bone fracture

- No other prior malignancy except for the following:

- Adequately treated basal cell or squamous cell skin cancer

- Adequately treated stage I or II cancer from which the patient is currently in
complete remission

- In situ cervical cancer

- Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 7 days since prior fine-needle aspiration or core biopsy

- At least 28 days since prior radiotherapy (14 days for palliative radiotherapy) and
recovered

- At least 28 days since prior surgery (e.g., thoracic or other major surgeries) and
recovered

- At least 28 days since prior systemic chemotherapy

- Prior biologic therapy allowed

- No prior gefitinib, erlotinib hydrochloride, bevacizumab, or other targeted therapies
against the epidermal growth factor receptor or vascular endothelial growth factor
axes

- Concurrent stable, therapeutic anticoagulation therapy allowed (e.g., 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 concurrent surgery

- No other concurrent nonprotocol treatment (including chemotherapy, hormonal therapy,
biological therapy, or radiotherapy) directed at this cancer

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

From time of registration to maximum of 3 years

Safety Issue:

No

Principal Investigator

Howard L. West, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000531056

NCT ID:

NCT00445848

Start Date:

July 2007

Completion Date:

July 2013

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • Adenocarcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
University of California Davis Cancer CenterSacramento, California  95817
Kaiser Permanente Medical Center - San Francisco Geary CampusSan Francisco, California  94115
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Broward General Medical Center Cancer CenterFt. Lauderdale, Florida  33316
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California  95051-5386
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Kaiser Permanente Medical Center - SacramentoSacramento, California  95825
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Peninsula Medical CenterBurlingame, California  94010
Kaiser Permanente - FremontFremont, California  94538
Sutter Health - Western Division Cancer Research GroupGreenbrae, California  94904
Marin Cancer Institute at Marin General HospitalGreenbrae, California  94904
Kaiser Permanente Medical Center - HaywardHayward, California  94545
Kaiser Permanente Medical Center - Redwood CityRedwood City, California  94063
Kaiser Permanente Medical Center - RichmondRichmond, California  94801
Kaiser Permanente Medical Center - RosevilleRoseville, California  95661
South Sacramento Kaiser-Permanente Medical CenterSacramento, California  95823
California Pacific Medical Center - California CampusSan Francisco, California  94118
Kaiser Permanente Medical Center - Santa TeresaSan Jose, California  95119
Kaiser Foundation Hospital - San RafaelSan Rafael, California  94903
Kaiser Permanente Medical Center - Santa RosaSanta Rosa, California  95403
Kaiser Permanente Medical Center - South San FranciscoSouth San Francisco, California  94080
Kaiser Permanente Medical Facility - StocktonStockton, California  95210
Kaiser Permanente Medical Center - Walnut CreekWalnut Creek, California  94596
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
Edward Hospital Cancer CenterNaperville, Illinois  60540
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Mecosta County Medical CenterBig Rapids, Michigan  49307
Highland Hospital of RochesterRochester, New York  14620
Iredell Memorial HospitalStatesville, North Carolina  28677
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
Northeast Georgia Medical CenterGainesville, Georgia  30501
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Randolph HospitalAsheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community HospitalGreensboro, North Carolina  27401
Annie Penn Cancer CenterReidsville, North Carolina  27320
Kaiser Permanente - Deer ValleyAntioch, California  94531
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Kaiser Permanente - DenverDenver, Colorado  80205
Kaiser Permanente - LafayetteLafayette, Colorado  80026
John B. Amos Cancer CenterColumbus, Georgia  31904
Harbin Clinic Cancer Center - Medical OncologyRome, Georgia  30165
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405
Kaiser Permanente - Moanalua Medical Center and ClinicHonolulu, Hawaii  96819
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Adventist Medical CenterPortland, Oregon  97216
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Harrison Poulsbo Hematology and OnocologyPoulsbo, Washington  98370
Evergreen Hematology and Oncology, PSSpokane, Washington  99218
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Pardee Memorial HospitalHendersonville, North Carolina  28791
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Boston University Cancer Research CenterBoston, Massachusetts  02118
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Tibotec Therapeutics - Division of Ortho Biotech Products, LPMarysville, California  95901
Valley Medical Oncology Consultants - PleasantonPleasanton, California  94588
Tahoe Forest Cancer CenterTruckee, California  96161
Mercy General Health PartnersMuskegon, Michigan  49443
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Shaw Regional Cancer CenterEdwards, Colorado  81632
Valley View Hospital Cancer CenterGlenwood Springs, Colorado  81601
Central Dupage Cancer CenterWarrenville, Illinois  60555
Cancer Care Center of DecaturDecatur, Illinois  62526