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

Small Cell Lung Cancer Clinical Trial

Official title:

A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403403
• Other study ID #: AVF3995g
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2006
• Last updated: April 27, 2011
• Start date: March 2007
• Est. completion date: June 2009

Study information

• Verified date: April 2011
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Bevacizumab
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
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)	Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.	Randomization until progression or lost to follow-up (up to 2 years)	No
Secondary	Overall Survival	Duration of overall survival from randomization until death or loss to follow-up	Randomization until death or lost of follow-up (up to 27 months)	No
Secondary	Percentage of Participants With an Objective Response	Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.; Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST): Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR	Randomization until progression or lost to follow-up (up to 2 years)	No
Secondary	Number of Participants With an Objective Response	Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.; Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST): Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR	Randomization until progression or lost to follow-up (up to 2 years)	No
Secondary	Duration of Objective Response	Duration of response was defined as time from the first response date to disease progression or on-study death (i.e., death occurring any time from randomization to 30 days after the final treatment with bevacizumab/placebo). Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.	Randomization until progression or lost to follow-up (up to 2 years)	No