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

NCT00095225 | Completed Phase 2

• 1 other identifier: OSI2950g
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 48

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.

Conditions

Non-Small-Cell Lung Carcinoma; Neoplasm Recurrence, Local

Keywords

Recurrent or refractory non-small cell lung cancer

Outcome Measures

Primary Outcomes (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.

Interventions

Avastin (bevacizumab) DRUG

Tarceva (erlotinib HCl) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (48)

Comprehensive Blood and Cancer Center (TORI)

Bakersfield, California, 93309, United States

Location

Bay Area Cancer Research Group

Concord, California, 94520, United States

Location

Virginia K. Crosson Cancer Center (TORI)

Fullerton, California, 92835, United States

Location

California Cancer Center, Inc

Greenbrae, California, 94904, United States

Location

Wilshire Oncology Medical Group (TORI)

Laverne, California, 91750, United States

Location

Pacific Shores Medical Group (TORI)

Long Beach, California, 90813-3244, United States

Location

UCLA Medical Center PVUB 3360

Los Angeles, California, 90095, United States

Location

Central Hematology Oncology Medical Group (TORI)

Monterey Park, California, 91754, United States

Location

North Valley Hematology/Oncology Medical Group (TORI)

Northridge, California, 91328, United States

Location

Ventura County Hematology-Oncology Specialists (TORI)

Oxnard, California, 93030, United States

Location

Cancer Care Associates Medical Group (TORI)

Redondo Beach, California, 90277, United States

Location

UC Davis Cancer Center

Sacramento, California, 95817, United States

Location

Kaiser Permanente/ San Diego

San Diego, California, 92120, United States

Location

Sansum Santa Barbara Medical Foundation Clinic (TORI)

Santa Barbara, California, 93105, United States

Location

Santa Barbara Hematology Oncology Medical Group, Inc (TORI)

Santa Barbara, California, 93105, United States

Location

Kaiser Permanente Northern CA

Vallejo, California, 94589, United States

Location

San Diego Cancer Center Medical Group (TORI)

Vista, California, 92081, United States

Location

Comprehensive Cancer Care Specialist at Boca Raton

Boca Raton, Florida, 33428, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

The Florida Cancer Institute(TORI)

Orlando, Florida, 32804, United States

Location

MD Anderson Cancer Ctr- Orlando

Orlando, Florida, 32806, United States

Location

Hematology and Oncology of Northeast Georgia, PC (TORI)

Athens, Georgia, 30607, United States

Location

Medical Oncology Associates, PC (TORI)

Augusta, Georgia, 30901, United States

Location

Suburban Hematology-Oncology Associates (TORI)

Lawrenceville, Georgia, 30045, United States

Location

WellStar Cancer Research Office

Marietta, Georgia, 30060, United States

Location

Atlanta Cancer Care (TORI)

Roswell, Georgia, 30076, United States

Location

Rush-Presbyteriam

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Loyola Univ. Medical Center

Maywood, Illinois, 60153, United States

Location

Hematology Oncology Consultants

Naperville, Illinois, 60540, United States

Location

Oncoloy Hematology Associates of Central Illinois, PC (TORI)

Peoria, Illinois, 61615, United States

Location

Norton Healthcare Louisville Oncology

Louisville, Kentucky, 40202, United States

Location

Ochsner Cancer Inst.

New Orleans, Louisiana, 70121, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, 04074, United States

Location

Methodist Cancer Center-Oncology Research

Omaha, Nebraska, 68114, United States

Location

Comprehensive Cancer Centers of Nevada (TORI)

Las Vegas, Nevada, 89109, United States

Location

Summit Medical Group Overlook Oncology Center

Summit, New Jersey, 07901, United States

Location

Cancer Research of Long Island

Great Neck, New York, 11023, United States

Location

Northwestern Carolina Oncology and Hematology

Hickory, North Carolina, 28603, United States

Location

Mid Dakota Clinic

Bismarck, North Dakota, 58501, United States

Location

Earle A. Chiles Research Institute

Portland, Oregon, 97213, United States

Location

Kaiser Permanente Northwest Region

Portland, Oregon, 97227, United States

Location

Univ. of Pittsburgh Cancer Center Inst.

Pittsburgh, Pennsylvania, 15232, United States

Location

University of Tenn. Cancer Ins

Memphis, Tennessee, 38104, United States

Location

The West Cancer Clinic

Memphis, Tennessee, 38120, United States

Location

M.D. Anderson

Houston, Texas, 77030, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Internal Medicine Associates of Yakima

Yakima, Washington, 98902, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Recurrence, Local; Recurrence

Interventions

Bevacizumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vince O'Neill, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 2004
• First Posted: November 2, 2004
• Study Start: July 1, 2004
• Study Completion: November 1, 2006
• Last Updated: January 29, 2008

Record last verified: 2008-01

Locations

US (48)