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

March 20, 2020 updated by: Southwest Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Antioch, California, United States, 94531
        • Kaiser Permanente - Deer Valley
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Comprehensive Cancer Center
      • Burlingame, California, United States, 94010
        • Peninsula Medical Center
      • Fremont, California, United States, 94538
        • Kaiser Permanente - Fremont
      • Hayward, California, United States, 94545
        • Kaiser Permanente Medical Center - Hayward
      • Marysville, California, United States, 95901
        • Tibotec Therapeutics - Division of Ortho Biotech Products, LP
      • Oakland, California, United States, 94611
        • Kaiser Permanente Medical Center - Oakland
      • Pleasanton, California, United States, 94588
        • Valley Medical Oncology Consultants - Pleasanton
      • Redwood City, California, United States, 94063
        • Kaiser Permanente Medical Center - Redwood City
      • Richmond, California, United States, 94801
        • Kaiser Permanente Medical Center - Richmond
      • Roseville, California, United States, 95661
        • Kaiser Permanente Medical Center - Roseville
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
      • Sacramento, California, United States, 95823
        • South Sacramento Kaiser-Permanente Medical Center
      • Sacramento, California, United States, 95825
        • Kaiser Permanente Medical Center - Sacramento
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Medical Center - San Francisco Geary Campus
      • San Francisco, California, United States, 94118
        • California Pacific Medical Center - California Campus
      • San Jose, California, United States, 95119
        • Kaiser Permanente Medical Center - Santa Teresa
      • San Rafael, California, United States, 94903
        • Sutter Health - Western Division Cancer Research Group
      • San Rafael, California, United States, 94903
        • Kaiser Foundation Hospital - San Rafael
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara Kiely Campus
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente Medical Center - Santa Rosa
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente Medical Center - South San Francisco
      • Stockton, California, United States, 95210
        • Kaiser Permanente Medical Facility - Stockton
      • Truckee, California, United States, 96161
        • Tahoe Forest Cancer Center
      • Vacaville, California, United States, 95688
        • Kaiser Permanente Medical Center - Vacaville
      • Vallejo, California, United States, 94589
        • Sutter Solano Medical Center
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center - Vallejo
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente Medical Center - Walnut Creek
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30342-1611
        • Northside Hospital Cancer Center
      • Atlanta, Georgia, United States, 30342-1701
        • Saint Joseph's Hospital of Atlanta
      • Atlanta, Georgia, United States, 30342
        • CCOP - Atlanta Regional
      • Austell, Georgia, United States, 30106
        • WellStar Cobb Hospital
      • Columbus, Georgia, United States, 31904
        • John B. Amos Cancer Center
      • Decatur, Georgia, United States, 30033
        • Charles B. Eberhart Cancer Center at DeKalb Medical Center
      • Fayetteville, Georgia, United States, 30214
        • Piedmont Fayette Hospital
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Lawrenceville, Georgia, United States, 30045
        • Gwinnett Medical Center
      • Marietta, Georgia, United States, 30060
        • Kennestone Cancer Center at Wellstar Kennestone Hospital
      • Riverdale, Georgia, United States, 30274-2600
        • Southern Regional Medical Center
      • Rome, Georgia, United States, 30165
        • Harbin Clinic Cancer Center - Medical Oncology
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente - Moanalua Medical Center and Clinic
    • Illinois
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital Cancer Care Institute
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Springfield, Illinois, United States, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, United States, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, United States, 67901
        • Cancer Center of Kansas, PA - Liberal
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas, PA - Salina
      • Salina, Kansas, United States, 67401
        • Tammy Walker Cancer Center at Salina Regional Health Center
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Cancer Center
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, United States, 67214
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, United States, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
    • Michigan
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Battle Creek, Michigan, United States, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, United States, 49307
        • Mecosta County Medical Center
      • Dearborn, Michigan, United States, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids, Michigan, United States, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, United States, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Jackson, Michigan, United States, 49201
        • Foote Memorial Hospital
      • Lansing, Michigan, United States, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, United States, 48154
        • St. Mary Mercy Hospital
      • Muskegon, Michigan, United States, 49443
        • Mercy General Health Partners
      • Pontiac, Michigan, United States, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Saginaw, Michigan, United States, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Warren, Michigan, United States, 48093
        • St. John Macomb Hospital
      • Wyoming, Michigan, United States, 49519
        • Metro Health Hospital
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, United States, 59107-7000
        • Billings Clinic - Downtown
      • Billings, Montana, United States, 59102
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, United States, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, United States, 59405-5309
        • Big Sky Oncology
      • Great Falls, Montana, United States, 59405
        • Sletten Cancer Institute at Benefis Healthcare
      • Havre, Montana, United States, 59501
        • Northern Montana Hospital
      • Helena, Montana, United States, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, United States, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, United States, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital, Incorporated
      • Hendersonville, North Carolina, United States, 28791
        • Pardee Memorial Hospital
    • Ohio
      • Bellefontaine, Ohio, United States, 43311
        • Mary Rutan Hospital
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, United States, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, United States, 43215
        • CCOP - Columbus
      • Columbus, Ohio, United States, 43215
        • Grant Medical Center Cancer Care
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital at Ohio Health
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Marietta, Ohio, United States, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Springfield, Ohio, United States, 45505
        • Community Hospital of Springfield and Clark County
      • Westerville, Ohio, United States, 43081
        • Mount Carmel St. Ann's Cancer Center
      • Zanesville, Ohio, United States, 43701
        • Genesis - Good Samaritan Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
    • Utah
      • American Fork, Utah, United States, 84003
        • American Fork Hospital
      • Cedar City, Utah, United States, 84720
        • Sandra L. Maxwell Cancer Center
      • Logan, Utah, United States, 84321
        • Logan Regional Hospital
      • Murray, Utah, United States, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, United States, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists at UCS Cancer Center
    • Washington
      • Bellingham, Washington, United States, 98225
        • St. Joseph Cancer Center
      • Bremerton, Washington, United States, 98310
        • Olympic Hematology and Oncology
      • Kennewick, Washington, United States, 99336
        • Columbia Basin Hematology
      • Mount Vernon, Washington, United States, 98274
        • Skagit Valley Hospital Cancer Care Center
      • Poulsbo, Washington, United States, 98370
        • Harrison Poulsbo Hematology and Onocology
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98104
        • Minor and James Medical, PLLC
      • Seattle, Washington, United States, 98112
        • Group Health Central Hospital
      • Seattle, Washington, United States, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, United States, 98195
        • University Cancer Center at University of Washington Medical Center
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest - Spokane South
      • Spokane, Washington, United States, 99218
        • Evergreen Hematology and Oncology, PS
      • Wenatchee, Washington, United States, 98801-2028
        • Wenatchee Valley Medical Center
    • Wyoming
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erlotinib and Bevacizumab
Biological: bevacizumab
Drug: erlotinib hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From date of registration to maximum of 3 years
From date of registration to maximum of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: 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
Time Frame: 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
Time Frame: From date of registration to maximum of 3 years
From date of registration to maximum of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

July 20, 2019

Study Completion (Actual)

August 20, 2019

Study Registration Dates

First Submitted

February 15, 2007

First Submitted That Met QC Criteria

February 15, 2007

First Posted (Estimate)

February 19, 2007

Study Record Updates

Last Update Posted (Actual)

April 2, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000529756
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0635 (Other Identifier: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Clinical Trials on bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe