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A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (RHUMAB VEGF; NSC 704865) in Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas


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 Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas


OBJECTIVES:

Primary

- Assess overall survival of patients with stage IIIB or IV primary non-small cell lung
adenocarcinoma who have never smoked and are treated with erlotinib hydrochloride and
bevacizumab.

Secondary

- Assess progression-free survival of patients treated with this regimen.

- Assess the response rate (confirmed and unconfirmed, complete and partial) in a subset
of patients with measurable disease treated with this regimen.

- Evaluate the frequency and severity of toxicities associated with this regimen in these
patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride 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 periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Adenocarcinoma

- No component of squamous cell carcinoma present

- Incompletely resected or unresectable disease

- Stage IIIB or IV disease as defined below:

- Selected 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 lung cancer in a separate lobe after resection or radiotherapy
within the past 5 years OR multifocal lesions in > 1 lobe considered stage
IV disease

- New lesions occurring ≥ 5 years after resection may be considered a separate primary
cancer and are not allowed if this is the only focus of lung cancer

- Measurable and/or nonmeasurable disease by CT scan, positron emission tomography
scan, or MRI

- Disease must be present outside a previous radiotherapy field OR a new lesion
must be inside the port

- Measurable disease must be assessed within the past 28 days

- Nonmeasurable disease must be assessed within the past 42 days

- Pleural effusions, ascites, and laboratory parameters are not acceptable as the
only evidence of disease

- Must be a lifelong nonsmoker (< 100 cigarettes in lifetime)

- 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/mm^3

- Platelet count ≥ 100,000/mm^3

- Total bilirubin normal

- SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases
present)

- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present)

- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min

- Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine
collection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Hypertension allowed if controlled on medication prior to study enrollment

- Must be willing to provide prior smoking history

- No immediate life-threatening complications from malignancies

- No prior major medical condition, psychological condition, or social situation that
would preclude study treatment

- 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 either thrombosis or hemorrhage, including hemorrhagic or thrombotic
stroke, or other CNS bleeding

- No serious nonhealing wound, ulcer, or bone fracture

- No other prior malignancy except for the following:

- Adequately treated basal cell or squamous cell skin cancer

- Adequately treated stage I or II cancer from which the patient is currently in
complete remission

- In situ cervical cancer

- Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 7 days since prior fine-needle aspiration or core biopsy

- At least 28 days since prior radiotherapy (14 days for palliative radiotherapy) and
recovered

- At least 28 days since prior surgery (e.g., thoracic or other major surgeries) and
recovered

- At least 28 days since prior systemic chemotherapy

- Prior biologic therapy allowed

- No prior gefitinib, erlotinib hydrochloride, bevacizumab, or other targeted therapies
against the epidermal growth factor receptor or vascular endothelial growth factor
axes

- Concurrent stable, therapeutic anticoagulation therapy allowed (e.g., 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 concurrent surgery

- No other concurrent nonprotocol treatment (including chemotherapy, hormonal therapy,
biological therapy, or radiotherapy) directed at this cancer

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 time 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: Food and Drug Administration

Study ID:

CDR0000531056

NCT ID:

NCT00445848

Start Date:

July 2007

Completion Date:

July 2013

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • Adenocarcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
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 - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Grand Rapids Grand Rapids, Michigan  49503
CCOP - Columbia River Oncology Program Portland, Oregon  97225
Kaiser Permanente Medical Center - Vallejo Vallejo, California  94589
University of California Davis Cancer Center Sacramento, California  95817
Kaiser Permanente Medical Center - San Francisco Geary Campus San Francisco, California  94115
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Northside Hospital Cancer Center Atlanta, Georgia  30342-1611
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Kaiser Permanente Medical Center - Oakland Sacramento, California  95825
Broward General Medical Center Cancer Center Ft. Lauderdale, Florida  33316
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
Interlakes Oncology/Hematology PC Rochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
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
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
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
Peninsula Medical Center Burlingame, California  94010
Kaiser Permanente - Fremont Fremont, California  94538
Sutter Health - Western Division Cancer Research Group Greenbrae, California  94904
Marin Cancer Institute at Marin General Hospital 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
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
Edward Hospital Cancer Center Naperville, Illinois  60540
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Mecosta County Medical Center Big Rapids, Michigan  49307
Highland Hospital of Rochester Rochester, New York  14620
Iredell Memorial Hospital Statesville, North Carolina  28677
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Montrose Memorial Hospital Cancer Center Montrose, Colorado  81401
Northeast Georgia Medical Center Gainesville, Georgia  30501
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
Randolph Hospital Asheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community Hospital Greensboro, North Carolina  27401
Annie Penn Cancer Center Reidsville, North Carolina  27320
Kaiser Permanente - Deer Valley Antioch, California  94531
Alta Bates Summit Comprehensive Cancer Center Berkeley, California  94704
Kaiser Permanente - Denver Denver, Colorado  80205
Kaiser Permanente - Lafayette Lafayette, Colorado  80026
John B. Amos Cancer Center Columbus, Georgia  31904
Harbin Clinic Cancer Center - Medical Oncology Rome, Georgia  30165
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Savannah, Georgia  31405
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
Adventist Medical Center Portland, Oregon  97216
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
Rocky Mountain Oncology Casper, Wyoming  82609
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
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
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Boston University Cancer Research Center Boston, Massachusetts  02118
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
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Shaw Regional Cancer Center Edwards, Colorado  81632
Valley View Hospital Cancer Center Glenwood Springs, Colorado  81601
Central Dupage Cancer Center Warrenville, Illinois  60555
Cancer Care Center of Decatur Decatur, Illinois  62526