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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS) Among All Randomized Patients

Outcome Description:

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.

Outcome 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)

Safety Issue:

No

Principal Investigator

Paula O'Connor, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

OSI3364g

NCT ID:

NCT00130728

Start Date:

June 2005

Completion Date:

July 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Avastin
  • Tarceva
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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