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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small-Cell Lung Carcinoma; Neoplasm Recurrence, Local
• Intervention / Treatment: Drug: Tarceva (erlotinib HCl); Drug: Avastin (bevacizumab)

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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) > 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Vince O'Neill, M.D., Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: November 1, 2004
• First Submitted That Met QC Criteria: November 1, 2004
• First Posted (Estimate): November 2, 2004

Study Record Updates

• Last Update Posted (Estimate): January 29, 2008
• Last Update Submitted That Met QC Criteria: January 23, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Recurrent or refractory non-small cell lung cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease Attributes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplastic Processes; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Recurrence; Neoplasm Recurrence, Local; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Erlotinib Hydrochloride; Bevacizumab
• Other Study ID Numbers: OSI2950g