A Study to Evaluate Bevacizumab and Chemotherapy or Tarceva in Treating Recurrent or Refractory NSCLC (Non-Small Cell Lung Cancer)
NCT ID: NCT00095225
Last Updated: 2008-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
122 participants
INTERVENTIONAL
2004-07-31
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Avastin (bevacizumab)
Tarceva (erlotinib HCl)
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically proven Stage IIIb with pleural effusion, or Stage IV, recurrent non-squamous NSCLC that is recurrent and unresectable
* Progression after one line of platinum-based chemotherapy (patients who have received prior docetaxel treatment are eligible to participate if there are no contraindications for pemetrexed treatment)
* Progression after previous adjuvant chemotherapy, if therapy was completed \>= 6 months prior to randomization and the patient has received one line of therapy for recurrent disease
* (Optional) Availability of archival diagnostic tissue (paraffin tissue block or 2-10 unstained slides representative of the patient's primary cancer)
* ECOG performance status of 0, 1, or 2
* Life expectancy \>= 3 months
* Measurable disease in accordance with RECIST
* Age \>= 18 years
* Use of an acceptable means of contraception (potentially fertile men and women) or documentation of infertility
Exclusion Criteria
* Treatment with an investigational or marketed agent that acts by anti-angiogenic mechanisms
* Previous treatment with more than one platinum-based chemotherapy
* Chemotherapy or radiotherapy within 28 days prior to randomization
* History of hemoptysis (\> 1 teaspoon) or presence of a cavitary lesion
* Clinical history of Grade \> 2 hematemesis within 6 months or Grade 1 hematemesis within 28 days prior to randomization
* History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure \> 150/100 mmHg on medication), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or Grade II or greater peripheral vascular disease
* History or clinical evidence of CNS or brain metastases or CNS bleeding
* History or clinical evidence of hemorrhagic or thrombotic stroke within the 6 months prior to randomization
* Centrally located lesions and lesions that abut major blood vessels
* Ongoing treatment with full-dose warfarin (or its equivalent) or heparin (or its equivalent; e.g., Lovenox(R))
* In-patient surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
* Minor surgical procedure, fine needle aspirations, or core biopsy within 7 days prior to randomization
* Anticipation of need for a major surgical procedure during the course of the study
* Serious, non-healing wound, ulcer, or bone fracture
* Inability to take oral medication or requirement for IV alimentation or total parenteral nutrition with lipids, or prior surgical procedures affecting absorption
* Any of the following abnormal hematologic values (within 1 week prior to randomization): ANC \<= 1,500 cells/uL; platelet count \<= 100,000 cells/uL; Hemoglobin \<= 9.0 g/dL; International normalized ratio (INR) \> 1.5 x upper limit of normal (ULN)
* For patients who will receive docetaxel, any of the following abnormal liver function tests (within 1 week prior to randomization): Serum bilirubin greater than ULN; Albumin \<= 2.5 g/dL; Serum ALT \>= 1.5 x ULN; Serum AST \>= 1.5 x ULN; Alkaline phosphatase \>= 2.5 x ULN
* Other baseline laboratory values: Serum creatinine \> 2.0 x ULN; Uncontrolled hypercalcemia ( \> 11.5 mg/dL); Urinary protein/creatinine ratio \>= 1 (spot urine) or clinically significant impairment of renal function; Estimated creatinine clearance \< 45 mL/min (for patients who will receive pemetrexed)
* Any active systemic bacterial, fungal, or viral infection, including known hepatitis C and HIV
* Pregnant or breast-feeding
* Presence of another cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix or non-melanomatous skin cancer
* Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Principal Investigators
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Vince O'Neill, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Comprehensive Blood and Cancer Center (TORI)
Bakersfield, California, United States
Bay Area Cancer Research Group
Concord, California, United States
Virginia K. Crosson Cancer Center (TORI)
Fullerton, California, United States
California Cancer Center, Inc
Greenbrae, California, United States
Wilshire Oncology Medical Group (TORI)
Laverne, California, United States
Pacific Shores Medical Group (TORI)
Long Beach, California, United States
UCLA Medical Center PVUB 3360
Los Angeles, California, United States
Central Hematology Oncology Medical Group (TORI)
Monterey Park, California, United States
North Valley Hematology/Oncology Medical Group (TORI)
Northridge, California, United States
Ventura County Hematology-Oncology Specialists (TORI)
Oxnard, California, United States
Cancer Care Associates Medical Group (TORI)
Redondo Beach, California, United States
UC Davis Cancer Center
Sacramento, California, United States
Kaiser Permanente/ San Diego
San Diego, California, United States
Sansum Santa Barbara Medical Foundation Clinic (TORI)
Santa Barbara, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc (TORI)
Santa Barbara, California, United States
Kaiser Permanente Northern CA
Vallejo, California, United States
San Diego Cancer Center Medical Group (TORI)
Vista, California, United States
Comprehensive Cancer Care Specialist at Boca Raton
Boca Raton, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
The Florida Cancer Institute(TORI)
Orlando, Florida, United States
MD Anderson Cancer Ctr- Orlando
Orlando, Florida, United States
Hematology and Oncology of Northeast Georgia, PC (TORI)
Athens, Georgia, United States
Medical Oncology Associates, PC (TORI)
Augusta, Georgia, United States
Suburban Hematology-Oncology Associates (TORI)
Lawrenceville, Georgia, United States
WellStar Cancer Research Office
Marietta, Georgia, United States
Atlanta Cancer Care (TORI)
Roswell, Georgia, United States
Rush-Presbyteriam
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Loyola Univ. Medical Center
Maywood, Illinois, United States
Hematology Oncology Consultants
Naperville, Illinois, United States
Oncoloy Hematology Associates of Central Illinois, PC (TORI)
Peoria, Illinois, United States
Norton Healthcare Louisville Oncology
Louisville, Kentucky, United States
Ochsner Cancer Inst.
New Orleans, Louisiana, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States
Methodist Cancer Center-Oncology Research
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada (TORI)
Las Vegas, Nevada, United States
Summit Medical Group Overlook Oncology Center
Summit, New Jersey, United States
Cancer Research of Long Island
Great Neck, New York, United States
Northwestern Carolina Oncology and Hematology
Hickory, North Carolina, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
Earle A. Chiles Research Institute
Portland, Oregon, United States
Kaiser Permanente Northwest Region
Portland, Oregon, United States
Univ. of Pittsburgh Cancer Center Inst.
Pittsburgh, Pennsylvania, United States
University of Tenn. Cancer Ins
Memphis, Tennessee, United States
The West Cancer Clinic
Memphis, Tennessee, United States
M.D. Anderson
Houston, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Internal Medicine Associates of Yakima
Yakima, Washington, United States
Countries
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Other Identifiers
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OSI2950g
Identifier Type: -
Identifier Source: org_study_id
NCT00098410
Identifier Type: -
Identifier Source: nct_alias
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