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

NCT ID: NCT00436332

Last Updated: 2020-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2019-08-20

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.

Detailed Description

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erlotinib and Bevacizumab

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: BIOLOGICAL

erlotinib hydrochloride

Intervention Type: DRUG

Interventions

bevacizumab

Intervention Type: BIOLOGICAL

erlotinib hydrochloride

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard L. West, MD

Role: STUDY_CHAIR

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Locations

Kaiser Permanente - Deer Valley

Antioch, California, United States

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, United States

Peninsula Medical Center

Burlingame, California, United States

Kaiser Permanente - Fremont

Fremont, California, United States

Kaiser Permanente Medical Center - Hayward

Hayward, California, United States

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, United States

Kaiser Permanente Medical Center - Oakland

Oakland, California, United States

Valley Medical Oncology Consultants - Pleasanton

Pleasanton, California, United States

Kaiser Permanente Medical Center - Redwood City

Redwood City, California, United States

Kaiser Permanente Medical Center - Richmond

Richmond, California, United States

Kaiser Permanente Medical Center - Roseville

Roseville, California, United States

University of California Davis Cancer Center

Sacramento, California, United States

South Sacramento Kaiser-Permanente Medical Center

Sacramento, California, United States

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, United States

Kaiser Permanente Medical Center - San Francisco Geary Campus

San Francisco, California, United States

California Pacific Medical Center - California Campus

San Francisco, California, United States

Kaiser Permanente Medical Center - Santa Teresa

San Jose, California, United States

Kaiser Foundation Hospital - San Rafael

San Rafael, California, United States

Sutter Health - Western Division Cancer Research Group

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, United States

Kaiser Permanente Medical Center - Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, United States

Kaiser Permanente Medical Facility - Stockton

Stockton, California, United States

Tahoe Forest Cancer Center

Truckee, California, United States

Kaiser Permanente Medical Center - Vacaville

Vacaville, California, United States

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, United States

Sutter Solano Medical Center

Vallejo, California, United States

Kaiser Permanente Medical Center - Walnut Creek

Walnut Creek, California, United States

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

Hartford, Connecticut, United States

Piedmont Hospital

Atlanta, Georgia, United States

Northside Hospital Cancer Center

Atlanta, Georgia, United States

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

CCOP - Atlanta Regional

Atlanta, Georgia, United States

WellStar Cobb Hospital

Austell, Georgia, United States

John B. Amos Cancer Center

Columbus, Georgia, United States

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, United States

Piedmont Fayette Hospital

Fayetteville, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, United States

Southern Regional Medical Center

Riverdale, Georgia, United States

Harbin Clinic Cancer Center - Medical Oncology

Rome, Georgia, United States

Kaiser Permanente - Moanalua Medical Center and Clinic

Honolulu, Hawaii, United States

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Cancer Center of Kansas, PA - Liberal

Liberal, Kansas, United States

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, United States

Cotton-O'Neil Cancer Center

Topeka, Kansas, United States

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, United States

Associates in Womens Health, PA - North Review

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, United States

CCOP - Wichita

Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, United States

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, United States

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, United States

Mecosta County Medical Center

Big Rapids, Michigan, United States

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, United States

CCOP - Grand Rapids

Grand Rapids, Michigan, United States

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, United States

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

Grosse Pointe Woods, Michigan, United States

Foote Memorial Hospital

Jackson, Michigan, United States

Sparrow Regional Cancer Center

Lansing, Michigan, United States

St. Mary Mercy Hospital

Livonia, Michigan, United States

Mercy General Health Partners

Muskegon, Michigan, United States

St. Joseph Mercy Oakland

Pontiac, Michigan, United States

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, United States

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

St. John Macomb Hospital

Warren, Michigan, United States

Metro Health Hospital

Wyoming, Michigan, United States

CCOP - Montana Cancer Consortium

Billings, Montana, United States

St. Vincent Healthcare Cancer Care Services

Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, United States

Billings Clinic - Downtown

Billings, Montana, United States

Bozeman Deaconess Cancer Center

Bozeman, Montana, United States

St. James Healthcare Cancer Care

Butte, Montana, United States

Big Sky Oncology

Great Falls, Montana, United States

Great Falls Clinic - Main Facility

Great Falls, Montana, United States

Sletten Cancer Institute at Benefis Healthcare

Great Falls, Montana, United States

Northern Montana Hospital

Havre, Montana, United States

St. Peter's Hospital

Helena, Montana, United States

Glacier Oncology, PLLC

Kalispell, Montana, United States

Kalispell Medical Oncology at KRMC

Kalispell, Montana, United States

Kalispell Regional Medical Center

Kalispell, Montana, United States

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, United States

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

Missoula, Montana, United States

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Mary Rutan Hospital

Bellefontaine, Ohio, United States

Adena Regional Medical Center

Chillicothe, Ohio, United States

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, United States

CCOP - Columbus

Columbus, Ohio, United States

Grant Medical Center Cancer Care

Columbus, Ohio, United States

Mount Carmel Health - West Hospital

Columbus, Ohio, United States

Doctors Hospital at Ohio Health

Columbus, Ohio, United States

Grady Memorial Hospital

Delaware, Ohio, United States

Fairfield Medical Center

Lancaster, Ohio, United States

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, United States

Knox Community Hospital

Mount Vernon, Ohio, United States

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, United States

Community Hospital of Springfield and Clark County

Springfield, Ohio, United States

Mount Carmel St. Ann's Cancer Center

Westerville, Ohio, United States

Genesis - Good Samaritan Hospital

Zanesville, Ohio, United States

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

American Fork Hospital

American Fork, Utah, United States

Sandra L. Maxwell Cancer Center

Cedar City, Utah, United States

Logan Regional Hospital

Logan, Utah, United States

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, United States

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

Ogden, Utah, United States

Utah Valley Regional Medical Center - Provo

Provo, Utah, United States

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, United States

LDS Hospital

Salt Lake City, Utah, United States

Dixie Regional Medical Center - East Campus

St. George, Utah, United States

St. Joseph Cancer Center

Bellingham, Washington, United States

Olympic Hematology and Oncology

Bremerton, Washington, United States

Columbia Basin Hematology

Kennewick, Washington, United States

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, United States

Harrison Poulsbo Hematology and Onocology

Poulsbo, Washington, United States

Harborview Medical Center

Seattle, Washington, United States

Minor and James Medical, PLLC

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Group Health Central Hospital

Seattle, Washington, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, United States

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Evergreen Hematology and Oncology, PS

Spokane, Washington, United States

Wenatchee Valley Medical Center

Wenatchee, Washington, United States

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

S0635

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000529756

Identifier Type: -

Identifier Source: org_study_id