Know Cancer

or
forgot password

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 Center Seattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
LDS Hospital Salt Lake City, Utah  84143
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Kaiser Permanente Medical Center - Vallejo Vallejo, California  94589
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
University of California Davis Cancer Center Sacramento, California  95817
Kaiser Permanente Medical Center - San Francisco Geary Campus San Francisco, California  94115
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Northside Hospital Cancer Center Atlanta, Georgia  30342-1611
Kaiser Permanente Medical Center - Oakland Sacramento, California  95825
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Munson Medical Center Traverse City, Michigan  49684
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Kaiser Permanente Medical Center - Santa Clara Kiely Campus Santa Clara, California  95051-5386
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
Kaiser Permanente Medical Center - Sacramento Sacramento, California  95825
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Peninsula Medical Center Burlingame, California  94010
Kaiser Permanente - Fremont Fremont, California  94538
Sutter Health - Western Division Cancer Research Group Greenbrae, California  94904
Kaiser Permanente Medical Center - Hayward Hayward, California  94545
Kaiser Permanente Medical Center - Redwood City Redwood City, California  94063
Kaiser Permanente Medical Center - Richmond Richmond, California  94801
Kaiser Permanente Medical Center - Roseville Roseville, California  95661
South Sacramento Kaiser-Permanente Medical Center Sacramento, California  95823
California Pacific Medical Center - California Campus San Francisco, California  94118
Kaiser Permanente Medical Center - Santa Teresa San Jose, California  95119
Kaiser Foundation Hospital - San Rafael San Rafael, California  94903
Kaiser Permanente Medical Center - Santa Rosa Santa Rosa, California  95403
Kaiser Permanente Medical Center - South San Francisco South San Francisco, California  94080
Kaiser Permanente Medical Facility - Stockton Stockton, California  95210
Sutter Solano Medical Center Vallejo, California  94589
Kaiser Permanente Medical Center - Walnut Creek Walnut Creek, California  94596
Saint Joseph's Hospital of Atlanta Atlanta, Georgia  30342-1701
Piedmont Hospital Atlanta, Georgia  30309
WellStar Cobb Hospital Austell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur, Georgia  30033
Gwinnett Medical Center Lawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta, Georgia  30060
Southern Regional Medical Center Riverdale, Georgia  30274-2600
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Mecosta County Medical Center Big Rapids, Michigan  49307
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Minor and James Medical, PLLC Seattle, Washington  98104
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Northeast Georgia Medical Center Gainesville, Georgia  30501
Kaiser Permanente - Deer Valley Antioch, California  94531
Alta Bates Summit Comprehensive Cancer Center Berkeley, California  94704
John B. Amos Cancer Center Columbus, Georgia  31904
Harbin Clinic Cancer Center - Medical Oncology Rome, Georgia  30165
Kaiser Permanente - Moanalua Medical Center and Clinic Honolulu, Hawaii  96819
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Liberal Liberal, Kansas  67905
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cotton-O'Neil Cancer Center Topeka, Kansas  66606
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Mary Rutan Hospital Bellefontaine, Ohio  43311
Grant Medical Center Cancer Care Columbus, Ohio  43215
Knox Community Hospital Mount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Harrison Poulsbo Hematology and Onocology Poulsbo, Washington  98370
Evergreen Hematology and Oncology, PS Spokane, Washington  99218
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Genesys Regional Medical Center Grand Blanc, Michigan  48439-8066
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Tibotec Therapeutics - Division of Ortho Biotech Products, LP Marysville, California  95901
Valley Medical Oncology Consultants - Pleasanton Pleasanton, California  94588
Tahoe Forest Cancer Center Truckee, California  96161
Mercy General Health Partners Muskegon, Michigan  49443
Piedmont Fayette Hospital Fayetteville, Georgia  30214
Kaiser Permanente Medical Center - Vacaville Vacaville, California  95688