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A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00130728
  Purpose

This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study. Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab
Drug: erlotinib HCl
Drug: placebo
Phase III

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Erlotinib Erlotinib hydrochloride Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title: A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva (Erlotinib) Compared With Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapy

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Objective response and duration of objective response [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Molecular exploratory markers and efficacy outcomes [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: June 2005
Estimated Study Completion Date: October 2009
Arms Assigned Interventions
1: Experimental Drug: bevacizumab
Intravenous repeating dose
Drug: erlotinib HCl
oral repeating dose
2: Placebo Comparator Drug: erlotinib HCl
oral repeating dose
Drug: placebo
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Cytologically or histologically confirmed NSCLC
  • Clinical or radiographic progression during or after first-line chemotherapy or chemoradiotherapy for NSCLC
  • Consent to provide archival tissue for analysis is required for participation in this study
  • ECOG performance status of 0, 1, or 2
  • Age ≥ 18 years
  • Use of an acceptable means of contraception for men and women of childbearing potential
  • INR no greater than 1.3 and an aPTT no greater than the upper limits of normal within 28 days prior to enrollment for patients not on low‑molecular‑weight heparin or fondaparinux

Exclusion Criteria:

  • Squamous cell carcinoma
  • Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent
  • Systemic chemotherapy, radiotherapy, or investigational treatment within 28 days prior to randomization
  • Local palliative radiotherapy within 14 days prior to randomization or persistent adverse effects from radiotherapy that have not resolved to Grade 2 or less following completion of treatment
  • Whole brain radiotherapy or stereotactic radiosurgery for brain metastases within 4 weeks of Day 0
  • Neurosurgery for brain metastases within 24 weeks of Day 0
  • Brain biopsy within 12 weeks of Day 0
  • Current use of dexamethasone for treatment associated with brain metastases
  • History of gross hemoptysis within 3 months prior to randomization unless definitively treated with surgery or radiation
  • History of any of the following within 6 months prior to Day 0: serious systemic disease, uncontrolled hypertension, unstable angina, New York Heart Association (NYHA) Grade 2 or greater CHF, unstable symptomatic arrhythmia requiring medication, clinically significant peripheral vascular disease, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
  • Evidence of bleeding diathesis or coagulopathy or other serious or acute internal bleeding within 6 months prior to randomization
  • CNS bleeding; history or clinical evidence of CNS stroke (hemorrhagic or thrombotic) within the last 6 months
  • Progressive neurologic symptoms in patients with a history of brain metastases
  • Full-dose anticoagulation with warfarin
  • Chronic daily use of aspirin or other full-dose NSAIDs with anti-platelet activity
  • 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
  • Pregnancy or breast-feeding
  • Presence of another invasive cancer within 5 years prior to randomization
  • Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130728

  Show 208 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Paula O'Connor, M.D. Genentech
  More Information

Responsible Party: Genentech, Inc. ( Paula O'Connor, M.D., Study Director )
Study ID Numbers: OSI3364g
Study First Received: August 12, 2005
Last Updated: April 22, 2008
ClinicalTrials.gov Identifier: NCT00130728  
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
NSCLC
Avastin
Tarceva
Lung Cancer

Study placed in the following topic categories:
Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Bevacizumab
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009