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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)


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 Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features (ADENOBAC)


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.

Inclusion Criteria


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

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 date 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: Federal Government

Study ID:

CDR0000529756

NCT ID:

NCT00436332

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • bronchoalveolar cell lung cancer
  • adenocarcinoma of the lung
  • Adenocarcinoma
  • Carcinoma
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Lung Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
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 - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
LDS HospitalSalt Lake City, Utah  84143
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
University of California Davis Cancer CenterSacramento, California  95817
Kaiser Permanente Medical Center - San Francisco Geary CampusSan Francisco, California  94115
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
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
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
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
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Peninsula Medical CenterBurlingame, California  94010
Kaiser Permanente - FremontFremont, California  94538
Sutter Health - Western Division Cancer Research GroupGreenbrae, 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
Sutter Solano Medical CenterVallejo, California  94589
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
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Mecosta County Medical CenterBig Rapids, Michigan  49307
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Minor and James Medical, PLLCSeattle, Washington  98104
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Northeast Georgia Medical CenterGainesville, Georgia  30501
Kaiser Permanente - Deer ValleyAntioch, California  94531
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
John B. Amos Cancer CenterColumbus, Georgia  31904
Harbin Clinic Cancer Center - Medical OncologyRome, Georgia  30165
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
Mary Rutan HospitalBellefontaine, Ohio  43311
Grant Medical Center Cancer CareColumbus, Ohio  43215
Knox Community HospitalMount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
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
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Pardee Memorial HospitalHendersonville, North Carolina  28791
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
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
Piedmont Fayette HospitalFayetteville, Georgia  30214
Kaiser Permanente Medical Center - VacavilleVacaville, California  95688