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

This study has been completed.

Sponsor:

Information provided by:

Genentech

ClinicalTrials.gov Identifier:

NCT00403403

First received: November 21, 2006

Last updated: April 27, 2011

Last verified: April 2011

History of Changes

Results First Received: January 28, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Small Cell Lung Cancer
Interventions:	Drug: Bevacizumab Drug: Chemotherapy Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Description

Placebo+Chemotherapy

Chemotherapy = cisplatin (or carboplatin) + etoposide. 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. 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

Chemotherapy = cisplatin (or carboplatin) + etoposide. 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. 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.

Participant Flow: Overall Study

	Placebo+Chemotherapy	Bevacizumab+Chemotherapy
STARTED	50	52
Safety-Evaluable Patients	47	51
COMPLETED	50	52
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo+Chemotherapy	Chemotherapy = cisplatin (or carboplatin) + etoposide. 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. 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	Chemotherapy = cisplatin (or carboplatin) + etoposide. 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. 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.
Total	Total of all reporting groups

Baseline Measures

	Placebo+Chemotherapy	Bevacizumab+Chemotherapy	Total
Number of Participants [units: participants]	50	52	102
Age [units: years] Mean ± Standard Deviation	64.0 ± 10.0	61.3 ± 8.5	62.7 ± 9.3
Gender [units: participants]
Female	20	26	46
Male	30	26	56

Outcome Measures

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1. Primary:

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

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2. Secondary:

Overall Survival [ Time Frame: Randomization until death or lost of follow-up (up to 27 months) ]

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3. Secondary:

Percentage of Participants With an Objective Response [ Time Frame: Randomization until progression or lost to follow-up (up to 2 years) ]

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4. Secondary:

Number of Participants With an Objective Response [ Time Frame: Randomization until progression or lost to follow-up (up to 2 years) ]

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5. Secondary:

Duration of Objective Response [ Time Frame: Randomization until progression or lost to follow-up (up to 2 years) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Medical Communications
Organization: Genentech, Inc.
phone: 800-821-8590

No publications provided

Responsible Party:	David Karlin, M.D., Study Director, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00403403 History of Changes
Other Study ID Numbers:	AVF3995g
Study First Received:	November 21, 2006
Results First Received:	January 28, 2010
Last Updated:	April 27, 2011
Health Authority:	United States: Food and Drug Administration

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