Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer
Condition: Extensive Stage Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: cisplatin; etoposide; bevacizumab; laboratory biomarker analysis
Intervention description: Given IV; Given IV; Given IV; Correlative studies
Intervention MeSH terms: Bevacizumab; Antineoplastic Agents, Immunological; Etoposide; Etoposide phosphate; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving cisplatin and etoposide together with
      bevacizumab works in treating patients with previously untreated extensive-stage small cell
      lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different
      ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies,
      such as bevacizumab, can block tumor growth in different ways. Some block the ability of
      tumor cells to grow and spread. Others find tumor cells and help kill them or deliver
      tumor-killing substances to them. Giving chemotherapy with a monoclonal antibody may kill
      more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic (or cytologic) proof of small cell lung cancer must be confirmed

          -  Patients must be clinically staged as extensive disease

          -  Patients must have measurable disease as defined by RECIST criteria; baseline
             scans/evaluation used to document measurable disease must be done within 4 weeks prior
             to registration; patients with measurable disease only or with both measurable and
             non-measurable disease are eligible

          -  Patients must have ECOG performance status of 0, 1, or 2

          -  Patients may not have had prior chemotherapy, immunotherapy, or biological therapy for
             lung cancer; previously irradiated lesions must not be the only site of measurable
             disease

          -  ANC > 1500/mm^3

          -  Platelets >= 100,000/mm^3

          -  Creatinine =< 1.5 mg

          -  Total bilirubin =< 1.5 mg

          -  Pregnant or breastfeeding women are excluded from the study because the agents used in
             this study may be teratogenic to a fetus or child and there is no information on the
             excretion of the agents or their metabolites into breast milk; all females of
             childbearing potential must have a blood test or urine study within 2 weeks, prior to
             registration to rule out pregnancy

          -  Women of childbearing potential and sexually active males are strongly advised to use
             an effective method of contraception

          -  Patients must be disease-free for > 5 years if they have a history of prior
             malignancies (except for cured basal or squamous cell skin cancers, or carcinoma in
             situ of the cervix)

          -  Patients must be considered on psychosocial grounds to be willing and able to comply
             with the requirements of treatment and follow-up

          -  Patients must not have CNS metastases; a head CT is required within 4 weeks prior to
             study entry for evaluation (MRIs are also acceptable)

          -  Urine dipstick for proteinuria of less than 1+ is required within 7 days prior to
             study entry; if urine dipstick is >= 1+ then a 24 hour urine for protein must
             demonstrate =< 1 gm of protein in 24 hours to allow participation in the study; NOTE:
             Urinalysis is also acceptable

          -  Patients must have INR =< 1.5 and a PTT no greater than the institutional upper limit
             of normal within 1 week prior to registration

          -  Patients must not have ongoing or active infection, symptomatic congestive heart
             failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
             situations that would limit compliance with study requirements

          -  Patients must not have history of thrombotic or hemorrhagic disorders; patients must
             not have recently (within 6 months of registration) experienced arterial
             thromboembolic events, including transient ischemic attack (TIA), cerebrovascular
             accident (CVA), unstable angina, or myocardial infarction (MI); patients must also not
             have clinically significant peripheral artery disease

          -  Patients with history of hypertension must be well-controlled (=< 150/85) on a stable
             regimen of anti-hypertensive therapy

          -  Patients must not be receiving chronic daily treatment with aspirin (> 325 mg/day) or
             nonsteroidal anti-inflammatory agents known to inhibit platelet function; treatment
             with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and/or
             cilostazol (Pletal) is also not allowed

          -  Patients must not have serious non-healing wound, ulcer, or bone fracture, or major
             surgical procedure within 28 days prior to starting treatment; patients must not have
             had minor surgery or needle biopsies within 7 days of treatment

          -  Patients must not be on therapeutic anticoagulation

          -  Patients with a history of gross hemoptysis (defined as bright red blood of a 1/2
             teaspoon or more) will be excluded from this trial

          -  Patients must have had no prior radiation therapy to the site of evaluable disease