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

Primary Purpose

Carcinoma, Small Cell Lung

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
irinotecan
carboplatin
bevacizumab
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Small Cell Lung focused on measuring Lung Cancer, Small Cell, Extensive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Florida Cancer Specialists
  • Oncology Hematology Care
  • Chattanooga Oncology Hematology Associates
  • Tennessee Oncology, PLLC

Outcomes

Primary Outcome Measures

median time to progression

Secondary Outcome Measures

overall toxicity
overall response rate
duration of response
overall survival

Full Information

First Posted
February 20, 2006
Last Updated
June 24, 2010
Sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00294931
Brief Title
Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Official Title
A Phase II Trial of Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc.

4. Oversight

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Small Cell Lung
Keywords
Lung Cancer, Small Cell, Extensive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irinotecan
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Primary Outcome Measure Information:
Title
median time to progression
Secondary Outcome Measure Information:
Title
overall toxicity
Title
overall response rate
Title
duration of response
Title
overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Spigel, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Chattanooga Oncology Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19875975
Citation
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. 2009 Dec;4(12):1555-60. doi: 10.1097/JTO.0b013e3181bbc540.
Results Reference
result
Links:
URL
http://journals.lww.com/jto/pages/articleviewer.aspx?year=2009&issue=12000&article=00018&type=abstract
Description
Published article in the Journal of Thoracic Oncology

Learn more about this trial

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

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