Cisplatin, Etoposide & Bevacizumab in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

This study has been completed.

Study NCT00079040 Information provided by Eastern Cooperative Oncology Group

First Received on March 8, 2004. Last Updated on February 3, 2010 History of Changes

Results First Received: November 19, 2009

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Lung Cancer
Interventions:	Biological: bevacizumab Drug: cisplatin Drug: etoposide

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
Participants were recruited from ECOG member institutions between June 8, 2004 and August 18, 2006.

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
Cisplatin, Etoposide, Bevacizumab	Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.

Participant Flow: Overall Study

	Cisplatin, Etoposide, Bevacizumab
STARTED	65
COMPLETED	63
NOT COMPLETED	2
Withdrew before treatment	1
Ineligible	1

Baseline Characteristics

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Reporting Groups

	Description
Cisplatin, Etoposide, Bevacizumab	Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.

Baseline Measures

	Cisplatin, Etoposide, Bevacizumab
Number of Participants [units: participants]	63
Age [units: Years] Median ( Full Range )	65 ( 45 to 83 )
Gender [units: participants]
Female	36
Male	27
Region of Enrollment [units: participants]
United States	63

Outcome Measures

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1. Primary:

Percentage of Participants Alive and Progression-free (PF) at 6 Months [ Time Frame: 6 months ]

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2. Secondary:

Overall Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 1 year ]

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3. Secondary:

Best Objective Response [ Time Frame: Assessed every 6 weeks ]

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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 NOT 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.

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: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012

Publications of Results:

Sandler A, Szwarc S, Dowlati A, et al.: A phase II study of cisplatin (P) plus etoposide (E) plus bevacizumab (B) for previously untreated extensive stage small cell lung cancer (SCLC) (E3501): a trial of the Eastern Cooperative Oncology Group. [Abstract] J Clin Oncol 25 (Suppl 18): A-7564, 400s, 2007.

Responsible Party:	Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00079040 History of Changes
Other Study ID Numbers:	CDR0000353484, ECOG-E3501
Study First Received:	March 8, 2004
Results First Received:	November 19, 2009
Last Updated:	February 3, 2010
Health Authority:	United States: Food and Drug Administration