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

Sponsor
Genentech, Inc.
Study ID
NCT00403403
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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).

Key Dates

First listed
Nov 23, 2006
Start date
Mar 31, 2007
Status verified
Apr 2011
Primary completion
Feb 28, 2009
Completion
Jun 30, 2009

Study Design

Enrollment
102 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo+Chemotherapy
    Chemotherapy = cisplatin (or carboplatin) + etoposide
  • Experimental: Bevacizumab+Chemotherapy
    Chemotherapy = cisplatin (or carboplatin) + etoposide

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Randomization until progression or lost to follow-up (up to 2 years) ]

Related Studies