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

Carcinoma, Small Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294931
• Other study ID #: SCRI LUN 90
• Secondary ID: AVF3256s
• Status: Completed
• Phase: Phase 2
• First received: February 20, 2006
• Last updated: June 24, 2010
• Start date: February 2006
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2009
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Carcinoma, Small Cell Lung
• Small Cell Lung Carcinoma

Intervention

Drug:
• irinotecan

• carboplatin

• bevacizumab

Locations

Country	Name	City	State
United States	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Spigel DR, Greco FA, Zubkus JD, Murphy PB, Saez RA, Farley C, Yardley DA, Burris HA 3rd, Hainsworth JD. Phase II trial of irinotecan, carboplatin, and bevacizumab in the treatment of patients with extensive-stage small-cell lung cancer. J Thorac Oncol. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median time to progression
Secondary	overall toxicity
Secondary	overall response rate
Secondary	duration of response
Secondary	overall survival

External Links

•   Published article in the Journal of Thoracic Oncology