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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
Open (Enrolling)
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



- 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


- 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

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


- 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


- 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

- 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

- 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


- 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

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

- 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

- 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:


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:


Principal Investigator

Howard L. West, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus


United States: Food and Drug Administration

Study ID:




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



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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
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University of California Davis Cancer Center Sacramento, California  95817
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Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
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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
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Kaiser Permanente Medical Center - Sacramento Sacramento, California  95825
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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
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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
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Cancer Center of Kansas-Independence Independence, Kansas  67301
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Associates in Womens Health, PA - North Review Wichita, Kansas  67208
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St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
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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
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Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Adventist Medical Center Portland, Oregon  97216
St. Joseph Cancer Center Bellingham, Washington  98225
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Metro Health Hospital Grand Rapids, Michigan  49506
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