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A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment

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Trial Conditions
  • Non-Small Cell Lung Cancer
What is the purpose of this trial?

This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Signed Informed Consent Form

- Histologically or cytologically confirmed NSCLC

- Advanced NSCLC or recurrent disease

- INR no greater than 1.3 and aPTT no greater than upper limits of normal (ULN) within
28 days prior to enrollment for subjects not on low molecular weight heparin or
fondaparinux. Subjects on low molecular weight heparin or fondaparinux are not
required to meet INR or aPTT limits. Chronic full-dose anticoagulation with warfarin
is not permitted.

- 18 years of age or older

- For women of childbearing potential and sexually active men, use of an accepted and
effective method of contraception (hormonal or barrier methods, abstinence) prior to
enrollment and for the duration of the study

Exclusion Criteria:

- Prior systemic chemotherapy in the metastatic setting

- Treatment with an investigational or marketed agent that acts by either EGFR
inhibition or anti-angiogenesis mechanisms

- Pregnancy or lactation

- Any other medical condition, including mental illness or substance abuse, deemed by
the clinician to be likely to interfere with a subject's ability to provide informed
consent, cooperate, and participate in the study, or to interfere with the
interpretation of the results

- Active infection or a fever within 3 days of enrollment

- Active malignancy other than lung cancer

- Radiation therapy to sites other than whole brain within 14 days prior to enrollment

- History of gross hemoptysis within 3 months prior to enrollment

- Known hypersensitivity to any of the components of cytotoxic chemotherapy
combinations, bevacizumab, or tyrosine kinase inhibitors

- Inadequately controlled hypertension

- Unstable angina or New York Heart Association Grade II or greater CHF

- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6
months prior to enrollment

- History of myocardial infarction within 6 months prior to enrollment

- History of stroke within 6 months prior to enrollment

- Symptomatic peripheral vascular disease within 6 months prior to enrollment

- Evidence of bleeding diathesis or coagulopathy

- Serious, non-healing wound, ulcer, or bone fracture

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to enrollment; anticipation of need for major surgical procedure during the
course of the study

- Current, recent, or planned participation in an experimental drug study other than
this Genentech-sponsored bevacizumab/erlotinib study

- Progressive neurologic symptoms in subjects with a history of brain metastases

- History of significant vascular disease (e.g., aortic aneurysm)

Gender: Both
Steward Physician(s)
  • Donald Strickland, M.D.
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Drug
  • bevacizumab
  • placebo
  • erlotinib HCl
Physician Researcher

Investigator Name:

  • Donald Strickland, M.D.

Other Information

Sponsor: Genentech
Phase: Phase 3
Trial ID: NCT00257608
Volunteers:  Not Accepting Healthy Volunteers

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