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:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00130728
First received: August 12, 2005
Last updated: September 26, 2011
Last verified: September 2011
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 636 |
| Study Start Date: | June 2005 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Drug: bevacizumab
intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
|
|
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
|
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
|
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
- 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
Contacts and Locations More Information
Additional Information:
No publications provided by Genentech
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00130728 History of Changes |
| Other Study ID Numbers: | OSI3364g |
| Study First Received: | August 12, 2005 |
| Results First Received: | November 16, 2009 |
| Last Updated: | September 26, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech:
|
NSCLC Avastin Tarceva Lung Cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Bevacizumab Erlotinib |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 16, 2012
