Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Sponsor

SCRI Development Innovations, LLC (Other)

Overall Status

Completed

CT.gov ID

NCT00294931

Collaborator

Genentech, Inc. (Industry)

Enrollment

Locations

Duration (Months)

12.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This multicenter phase II trial is designed to study the unique combination of chemotherapy (irinotecan./carboplatin) and bevacizumab in the extensive-stage setting. This clinical setting seems ideal for evaluation of the role of bevacizumab in delaying progression and prolonging survival.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Small Cell Lung	Drug: irinotecan Drug: carboplatin Drug: bevacizumab	Phase 2

Detailed Description

Eligible patients will receive 6 courses of irinotecan, carboplatin, and bevacizumab. The interval between chemotherapy courses will be 28 days. If after 6 courses of treatment, patient's response is a CR/PR/SD they will continue on Bevacizumab until tumor progression or up to 6 cycles (6 months) total.

Treatment sequence:

Irinotecan 60mg/m2 on days 1, 8, and 15
Carboplatin AUC=4 day 1 only
Bevacizumab 10 mg/kg days 1 and 15

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Trial of Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

Jan 1, 2009

Outcome Measures

Primary Outcome Measures

median time to progression []

Secondary Outcome Measures

overall toxicity []
overall response rate []
duration of response []
overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed small cell lung cancer,extensive stage disease.
Measurable or evaluable disease
No previous chemotherapy
Able to perform activities of daily living with minimal assistance
Adequate hematological, live and kidney function
Provide written informed consent

Exclusion Criteria:

Limited stage disease
PEG or G tubes
Hemoptysis
Abdominal fistula, perforation, or abscess within the previous 6 months
Women who are pregnant or lactating
Proteinuria
Serious nonhealing wound, ulcer, or bone fracture
Evidence of bleeding diathesis or coagulopathy
Uncontrolled or serious cardiovascular disease
Uncontrolled brain metastasis
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days; Fine needle aspiration within 7 days
Patients requiring full-dose anticoagulation must be on a stable dosing schedule prior to enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Cancer Specialists	Fort Myers	Florida	United States	33901
2	Oncology Hematology Care	Cincinnati	Ohio	United States	45242
3	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee	United States	37404
4	Tennessee Oncology, PLLC	Nashville	Tennessee	United States	37023