A Study to Evaluate Bevacizumab and Chemotherapy or Tarceva in Treating Recurrent or Refractory NSCLC (Non-Small Cell Lung Cancer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00095225
Recruitment Status : Completed
First Posted : November 2, 2004
Last Update Posted : January 29, 2008
Information provided by:
Genentech, Inc.

Brief Summary:
This Phase II, multicenter, randomized trial is designed to make preliminary evaluations of the efficacy of combining bevacizumab with chemotherapy (docetaxel or pemetrexed) or Tarceva relative to chemotherapy (docetaxel or pemetrexed) alone in patients with previously treated advanced NSCLC.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Neoplasm Recurrence, Local Drug: Avastin (bevacizumab) Drug: Tarceva (erlotinib HCl) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy (Docetaxel or Pemetrexed) or Tarceva (Erlotinib) Compared With Chemotherapy (Docetaxel or Pemetrexed) Alone for Treatment of Recurrent or Refractory Non-Small Cell Lung Cancer
Study Start Date : July 2004
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. To evaluate the safety and preliminary efficacy of combining bevacizumab with chemotherapy or Tarceva relative to chemotherapy alone on patients with previously treated advanced non-small cell lung cancer.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed written informed consent
  • 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:

  • More than 30 days of prior treatment with an investigational or marketed agent that acts by EGFR inhibition (those with 30 or fewer days on an EGFR inhibitor without disease progression are eligible for enrollment)
  • 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) &gt; 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 &gt; 2.0 x ULN; Uncontrolled hypercalcemia ( &gt; 11.5 mg/dL); Urinary protein/creatinine ratio >= 1 (spot urine) or clinically significant impairment of renal function; Estimated creatinine clearance &lt; 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00095225

  Hide Study Locations
United States, California
Comprehensive Blood and Cancer Center (TORI)
Bakersfield, California, United States, 93309
Bay Area Cancer Research Group
Concord, California, United States, 94520
Virginia K. Crosson Cancer Center (TORI)
Fullerton, California, United States, 92835
California Cancer Center, Inc
Greenbrae, California, United States, 94904
Wilshire Oncology Medical Group (TORI)
Laverne, California, United States, 91750
Pacific Shores Medical Group (TORI)
Long Beach, California, United States, 90813-3244
UCLA Medical Center PVUB 3360
Los Angeles, California, United States, 90095
Central Hematology Oncology Medical Group (TORI)
Monterey Park, California, United States, 91754
North Valley Hematology/Oncology Medical Group (TORI)
Northridge, California, United States, 91328
Ventura County Hematology-Oncology Specialists (TORI)
Oxnard, California, United States, 93030
Cancer Care Associates Medical Group (TORI)
Redondo Beach, California, United States, 90277
UC Davis Cancer Center
Sacramento, California, United States, 95817
Kaiser Permanente/ San Diego
San Diego, California, United States, 92120
Sansum Santa Barbara Medical Foundation Clinic (TORI)
Santa Barbara, California, United States, 93105
Santa Barbara Hematology Oncology Medical Group, Inc (TORI)
Santa Barbara, California, United States, 93105
Kaiser Permanente Northern CA
Vallejo, California, United States, 94589
San Diego Cancer Center Medical Group (TORI)
Vista, California, United States, 92081
United States, Florida
Comprehensive Cancer Care Specialist at Boca Raton
Boca Raton, Florida, United States, 33428
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
The Florida Cancer Institute(TORI)
Orlando, Florida, United States, 32804
MD Anderson Cancer Ctr- Orlando
Orlando, Florida, United States, 32806
United States, Georgia
Hematology and Oncology of Northeast Georgia, PC (TORI)
Athens, Georgia, United States, 30607
Medical Oncology Associates, PC (TORI)
Augusta, Georgia, United States, 30901
Suburban Hematology-Oncology Associates (TORI)
Lawrenceville, Georgia, United States, 30045
WellStar Cancer Research Office
Marietta, Georgia, United States, 30060
Atlanta Cancer Care (TORI)
Roswell, Georgia, United States, 30076
United States, Illinois
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637
Loyola Univ. Medical Center
Maywood, Illinois, United States, 60153
Hematology Oncology Consultants
Naperville, Illinois, United States, 60540
Oncoloy Hematology Associates of Central Illinois, PC (TORI)
Peoria, Illinois, United States, 61615
United States, Kentucky
Norton Healthcare Louisville Oncology
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Cancer Inst.
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States, 04074
United States, Nebraska
Methodist Cancer Center-Oncology Research
Omaha, Nebraska, United States, 68114
United States, Nevada
Comprehensive Cancer Centers of Nevada (TORI)
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Summit Medical Group Overlook Oncology Center
Summit, New Jersey, United States, 07901
United States, New York
Cancer Research of Long Island
Great Neck, New York, United States, 11023
United States, North Carolina
Northwestern Carolina Oncology and Hematology
Hickory, North Carolina, United States, 28603
United States, North Dakota
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
United States, Oregon
Earle A. Chiles Research Institute
Portland, Oregon, United States, 97213
Kaiser Permanente Northwest Region
Portland, Oregon, United States, 97227
United States, Pennsylvania
Univ. of Pittsburgh Cancer Center Inst.
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
University of Tenn. Cancer Ins
Memphis, Tennessee, United States, 38104
The West Cancer Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
M.D. Anderson
Houston, Texas, United States, 77030
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Internal Medicine Associates of Yakima
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Genentech, Inc.
Study Director: Vince O'Neill, M.D. Genentech, Inc. Identifier: NCT00095225     History of Changes
Obsolete Identifiers: NCT00098410
Other Study ID Numbers: OSI2950g
First Posted: November 2, 2004    Key Record Dates
Last Update Posted: January 29, 2008
Last Verified: January 2008

Keywords provided by Genentech, Inc.:
Recurrent or refractory non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Recurrence, Local
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Disease Attributes
Pathologic Processes
Neoplastic Processes
Erlotinib Hydrochloride
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action