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

NCT00403403 | Completed Phase 2 Results

• 1 other identifier: AVF3995g
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Small Cell Lung Cancer

Keywords

SCLC; SALUTE; Lung Cancer; Avastin

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Overall Survival

  Randomization until death or lost of follow-up (up to 27 months)

• Percentage of Participants With an Objective Response

  Randomization until progression or lost to follow-up (up to 2 years)

• Number of Participants With an Objective Response

  Randomization until progression or lost to follow-up (up to 2 years)

• Duration of Objective Response

  Randomization until progression or lost to follow-up (up to 2 years)

Study Arms (2)

Placebo+Chemotherapy

PLACEBO COMPARATOR

Chemotherapy = cisplatin (or carboplatin) + etoposide

Drug: Chemotherapy; Drug: Placebo

Bevacizumab+Chemotherapy

EXPERIMENTAL

Chemotherapy = cisplatin (or carboplatin) + etoposide

Drug: Bevacizumab; Drug: Chemotherapy

Interventions

Bevacizumab DRUG

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.

Bevacizumab+Chemotherapy

Chemotherapy DRUG

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.

Bevacizumab+Chemotherapy; Placebo+Chemotherapy

Placebo DRUG

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.

Placebo+Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Lung Neoplasms

Interventions

Bevacizumab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

800-821-8590

Study Officials

• David Karlin, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 23, 2006
• Study Start: March 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 29, 2011
• Results First Posted: February 25, 2011

Record last verified: 2011-04