A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Bevacizumab; Chemotherapy; Placebo
Intervention description: Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death.; Chemotherapy = cisplatin (or carboplatin) + etoposide. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.; Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death.
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SCLC; SALUTE; Lung Cancer; Avastin

Summary:

      This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary
      evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or
      carboplatin) and etoposide in patients with previously untreated extensive-stage small cell
      lung cancer (SCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically documented small cell carcinoma of the bronchus,
             classified as extensive-stage disease

          -  Measurable disease or lesions

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

        Exclusion Criteria:

          -  Life expectancy of < 12 weeks

          -  Current, recent, or planned participation in another experimental drug study

          -  Ongoing or active infection

          -  Active malignancy other than SCLC or superficial basal/squamous cell carcinoma within
             the previous 5 years

          -  Prior systemic therapy, radiation therapy, or surgery for SCLC

          -  Inadequate bone marrow function, renal function, or hepatic function

          -  Serum sodium of < 120 mg/dL

          -  Inadequately controlled hypertension

          -  History of hypertensive crisis or hypertensive encephalopathy

          -  New York Heart Association Class II or greater congestive heart failure

          -  History of myocardial infarction or unstable angina within 6 months prior to study
             enrollment

          -  History of stroke or transient ischemic attack within 6 months prior to study
             enrollment

          -  Known central nervous system disease, except for brain metastases treated with
             whole-brain radiotherapy

          -  Significant vascular disease or recent peripheral arterial thrombosis within 6 months
             prior to study enrollment

          -  History of hemoptysis within 4 weeks prior to study enrollment

          -  Evidence of bleeding diathesis or coagulopathy in the absence of therapeutic
             anticoagulation

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to study enrollment or anticipation of a need for a major surgical procedure
             during the course of the study

          -  Core biopsy or other minor surgical procedure, including placement of a vascular
             access device, within 7 days prior to Day 1

          -  History of abdominal fistula or gastrointestinal perforation within 6 months prior to
             study enrollment

          -  Serious, non-healing wound, active ulcer, or untreated bone fracture

          -  Known hypersensitivity to any component of bevacizumab

          -  Pregnant (positive pregnancy test) or lactating