S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma

NCT00436332 | Completed Phase 2 Results

• 3 other identifiers: CDR0000529756S0635U10CA032102
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 148

Brief Summary

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From date of registration to maximum of 3 years

Secondary Outcomes (3)

• Progression-free Survival

  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

  From date of registration to maximum of 3 years

• Frequency and Severity of Toxicities

  From date of registration to maximum of 3 years

Study Arms (1)

Erlotinib and Bevacizumab

EXPERIMENTAL

Biological: bevacizumab; Drug: erlotinib hydrochloride

Interventions

bevacizumab BIOLOGICAL

Erlotinib and Bevacizumab

erlotinib hydrochloride DRUG

Erlotinib and Bevacizumab

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (148)

Kaiser Permanente - Deer Valley

Antioch, California, 94531, United States

Location

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Peninsula Medical Center

Burlingame, California, 94010, United States

Location

Kaiser Permanente - Fremont

Fremont, California, 94538, United States

Location

Kaiser Permanente Medical Center - Hayward

Hayward, California, 94545, United States

Location

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, 95901, United States

Location

Kaiser Permanente Medical Center - Oakland

Oakland, California, 94611, United States

Location

Valley Medical Oncology Consultants - Pleasanton

Pleasanton, California, 94588, United States

Location

Kaiser Permanente Medical Center - Redwood City

Redwood City, California, 94063, United States

Location

Kaiser Permanente Medical Center - Richmond

Richmond, California, 94801, United States

Location

Kaiser Permanente Medical Center - Roseville

Roseville, California, 95661, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

South Sacramento Kaiser-Permanente Medical Center

Sacramento, California, 95823, United States

Location

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, 95825, United States

Location

Kaiser Permanente Medical Center - San Francisco Geary Campus

San Francisco, California, 94115, United States

Location

California Pacific Medical Center - California Campus

San Francisco, California, 94118, United States

Location

Kaiser Permanente Medical Center - Santa Teresa

San Jose, California, 95119, United States

Location

Kaiser Foundation Hospital - San Rafael

San Rafael, California, 94903, United States

Location

Sutter Health - Western Division Cancer Research Group

San Rafael, California, 94903, United States

Location

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, 95051, United States

Location

Kaiser Permanente Medical Center - Santa Rosa

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, 94080, United States

Location

Kaiser Permanente Medical Facility - Stockton

Stockton, California, 95210, United States

Location

Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

Kaiser Permanente Medical Center - Vacaville

Vacaville, California, 95688, United States

Location

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, 94589, United States

Location

Sutter Solano Medical Center

Vallejo, California, 94589, United States

Location

Kaiser Permanente Medical Center - Walnut Creek

Walnut Creek, California, 94596, United States

Location

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Northside Hospital Cancer Center

Atlanta, Georgia, 30342-1611, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342-1701, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342, United States

Location

WellStar Cobb Hospital

Austell, Georgia, 30106, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, 30033, United States

Location

Piedmont Fayette Hospital

Fayetteville, Georgia, 30214, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30045, United States

Location

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Southern Regional Medical Center

Riverdale, Georgia, 30274-2600, United States

Location

Harbin Clinic Cancer Center - Medical Oncology

Rome, Georgia, 30165, United States

Location

Kaiser Permanente - Moanalua Medical Center and Clinic

Honolulu, Hawaii, 96819, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Cancer Center of Kansas, PA - Liberal

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67401, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cotton-O'Neil Cancer Center

Topeka, Kansas, 66606, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Mecosta County Medical Center

Big Rapids, Michigan, 49307, United States

Location

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, 48123-2500, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Foote Memorial Hospital

Jackson, Michigan, 49201, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48912-1811, United States

Location

St. Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Mercy General Health Partners

Muskegon, Michigan, 49443, United States

Location

St. Joseph Mercy Oakland

Pontiac, Michigan, 48341-2985, United States

Location

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, 48060, United States

Location

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, 48601, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48093, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Care Services

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59102, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Healthcare Cancer Care

Butte, Montana, 59701, United States

Location

Big Sky Oncology

Great Falls, Montana, 59405-5309, United States

Location

Great Falls Clinic - Main Facility

Great Falls, Montana, 59405, United States

Location

Sletten Cancer Institute at Benefis Healthcare

Great Falls, Montana, 59405, United States

Location

Northern Montana Hospital

Havre, Montana, 59501, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology at KRMC

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

Mary Rutan Hospital

Bellefontaine, Ohio, 43311, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Grant Medical Center Cancer Care

Columbus, Ohio, 43215, United States

Location

Mount Carmel Health - West Hospital

Columbus, Ohio, 43222, United States

Location

Doctors Hospital at Ohio Health

Columbus, Ohio, 43228, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Knox Community Hospital

Mount Vernon, Ohio, 43050, United States

Location

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Community Hospital of Springfield and Clark County

Springfield, Ohio, 45505, United States

Location

Mount Carmel St. Ann's Cancer Center

Westerville, Ohio, 43081, United States

Location

Genesis - Good Samaritan Hospital

Zanesville, Ohio, 43701, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

American Fork Hospital

American Fork, Utah, 84003, United States

Location

Sandra L. Maxwell Cancer Center

Cedar City, Utah, 84720, United States

Location

Logan Regional Hospital

Logan, Utah, 84321, United States

Location

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, 84106, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center - East Campus

St. George, Utah, 84770, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Columbia Basin Hematology

Kennewick, Washington, 99336, United States

Location

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, 98274, United States

Location

Harrison Poulsbo Hematology and Onocology

Poulsbo, Washington, 98370, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical, PLLC

Seattle, Washington, 98104, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Evergreen Hematology and Oncology, PS

Spokane, Washington, 99218, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801-2028, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma, Bronchiolo-Alveolar; Adenocarcinoma of Lung

Interventions

Bevacizumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Lung Committee Statistician
• Organization: SWOG Statistical Center

jmoon@fhcrc.org

206-667-6197

Study Officials

• Howard L. West, MD

  Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: February 19, 2007
• Study Start: July 1, 2007
• Primary Completion: July 20, 2019
• Study Completion: August 20, 2019
• Last Updated: April 2, 2020
• Results First Posted: December 22, 2016

Record last verified: 2020-03

Locations

US (148)