Erlotinib + Bevacizumab for PS 2 Chemotherapy Naïve Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Erlotinib; Bevacizumab
Intervention description: Erlotinib 150 mg qd days 1-21; Bevacizumab 15 mg/kg IV, day 1
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The strategy for combining therapeutic agents in cancer treatments has been successful in
      multiple tumor types, including NSCLC. Erlotinib and bevacizumab target different pathways
      involved in tumor growth. Nonclinical studies have demonstrated that the combination of
      bevacizumab and erlotinib results in greater efficacy than either agent alone. Furthermore,
      because there is little to no overlap in toxicity profile between the two agents, the
      combination is expected to be well tolerated and may provide even greater benefit for
      patients who are unable to receive cytotoxic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological proof of non-small cell lung cancer meeting one of the following
             criteria:

               -  stage III b with a pleural effusion

               -  stage IV

          -  Histology must not be squamous cell.

          -  No prior chemotherapy or hormonal therapy.

          -  Prior radiation therapy must be completed at least 21 days prior to being registered
             for protocol therapy.

          -  No prior use of an epidermal growth factor receptor (EGFR) inhibitor or antiangiogenic
             agent.

          -  No treatment with any investigational agent within 30 days prior to being registered
             for protocol therapy.

          -  Measurable disease according to RECIST and obtained by imaging within 28 days prior to
             being registered for protocol therapy.

          -  ECOG Performance Status of 2 in the opinion of the treating investigator.

          -  Age > 18 years at the time of consent.

          -  Females of childbearing potential and males must be willing to use an effective method
             of contraception (hormonal or barrier method of birth control; abstinence) while on
             treatment and for a 6 week period thereafter.

          -  Females of childbearing potential must have a negative pregnancy test within 7 days
             prior to being registered for protocol therapy. Subjects are considered not of child
             bearing potential if they are surgically sterile (they have undergone a hysterectomy,
             bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.

          -  Females must not be breastfeeding.

          -  Able to comply with study and/or follow-up procedures.

        Exclusion Criteria:

          -  Evidence of bleeding diathesis or coagulopathy.

          -  Evidence of central nervous system involvement or brain metastases confirmed by head
             CT or brain MRI within 28 days prior to being registered for protocol therapy.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to registration for protocol therapy.

          -  Anticipation of need for major surgical procedure during the course of the study.

          -  Minor surgical procedures such as fine needle aspirations or core biopsies within 7
             days prior to registration for protocol therapy.

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to registration for protocol therapy.

          -  Serious, non-healing wound, ulcer, or bone fracture.

          -  History of hemoptysis.

          -  Clinically significant infections as judged by the treating investigator.

          -  Other active malignancy