A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)

Genentech

Status and phase: Completed; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Drug: Bevacizumab; Drug: Placebo; Drug: Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00403403

AVF3995g

Details and patient eligibility

About

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).

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups, including a placebo group

Placebo+Chemotherapy

Placebo Comparator group

Description:

Chemotherapy = cisplatin (or carboplatin) + etoposide

Treatment:

Drug: Placebo

Drug: Chemotherapy

Bevacizumab+Chemotherapy

Experimental group

Description:

Chemotherapy = cisplatin (or carboplatin) + etoposide

Treatment:

Drug: Chemotherapy

Drug: Bevacizumab