Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00130728
First received: August 12, 2005
Last updated: September 26, 2011
Last verified: September 2011

August 12, 2005
September 26, 2011
June 2005
July 2008   (final data collection date for primary outcome measure)
Overall Survival (OS) Among All Randomized Patients [ Time Frame: From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years) ] [ Designated as safety issue: No ]
Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.
To evaluate the efficacy of combining bevacizumab with Tarceva (erlotinib) relative to Tarceva monotherapy in second line patients with advanced NSCLC, as measured by overall survival.
Complete list of historical versions of study NCT00130728 on ClinicalTrials.gov Archive Site
  • Progression-free Survival (PFS) [ Time Frame: From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years) ] [ Designated as safety issue: No ]
    PFS was defined as the time from randomization to documented disease progression, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), or death on study treatment, whichever occurred first.
  • Percentage of Participants With Objective Response [ Time Frame: The median duration of Objective response was up to 9.7 months ] [ Designated as safety issue: No ]
    Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions >= 4 weeks apart.
  • Duration of Objective Response [ Time Frame: Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months) ] [ Designated as safety issue: No ]
    Duration of objective response was defined as the period from the date of the initial partial or complete response until the date of disease progression or death on study treatment from any cause. For patients who had not died, data was censored at the date of last contact.
To evaluate the safety, efficacy, and pharmacokinetic behavior of combining bevacizumab with Tarceva in patients with previously treated NSCLC.
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: bevacizumab
    intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
  • Drug: erlotinib HCl
    oral erlotinib HCl 150 mg/day orally
  • Drug: placebo
    intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
  • Experimental: erlotinib HCl + bevacizumab
    oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
    Intervention: Drug: bevacizumab
  • Placebo Comparator: erlotinib HCl + placebo
    oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
    Interventions:
    • Drug: erlotinib HCl
    • Drug: placebo
Herbst RS, Ansari R, Bustin F, Flynn P, Hart L, Otterson GA, Vlahovic G, Soh CH, O'Connor P, Hainsworth J. Efficacy of bevacizumab plus erlotinib versus erlotinib alone in advanced non-small-cell lung cancer after failure of standard first-line chemotherapy (BeTa): a double-blind, placebo-controlled, phase 3 trial. Lancet. 2011 May 28;377(9780):1846-54.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
636
July 2008
July 2008   (final data collection date for primary outcome measure)

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
  • Eastern Cooperative Oncology Group (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
  • International normalized ratio (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 Epidermal Growth Factor Receptor (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 Congestive Heart Failure (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
  • Central Nervous System (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 nonsteroidal anti-inflammatory drugs (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 intravenous (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00130728
OSI3364g
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Paula O'Connor, M.D. Genentech, Inc.
Genentech, Inc.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP