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Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Limited Stage Small Cell Lung Cancer

Primary Purpose

Carcinoma, Small Cell Lung, Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
irinotecan
carboplatin
bevacizumab
Radiation Therapy
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 Carcinoma Small Cell Lung, Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: Histologically-confirmed small cell lung cancer. Limited stage disease ( ECOG performance status 0 or 1. No previous treatment with chemotherapy, radiation therapy, or biologic agents. Measurable disease Adequate bone marrow, liver, kidney function Patients must be able to understand the nature of this study and give written consent. Exclusion Criteria: Age < 18 years History of a prior malignancy within three years with the exception of skin cancer (excluding melanoma), cervical carcinoma in situ, in situ breast carcinoma, or early stage prostate cancer. Women who are pregnant or lactating are ineligible. Men and women of childbearing potential are required to use adequate contraception during this study. History or physical exam evidence of CNS disease (eg seizures not controlled with standard medical therapy, history of stroke) Active infection requiring parenteral antibiotics Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or fine needle aspiration within 7 days of beginning bevacizumab or anticipation of need for major surgical procedure during the course of the study. Full-dose oral or parenteral anticoagulation must be on a stable dosing schedule prior to enrollment. Proteinuria Serious nonhealing wound, ulcer, or bone fracture Evidence of bleeding diathesis or coagulopathy Prior hemoptysis. History of acute myocardial infarction or stroke within 6 months Uncontrolled hypertension (> 150/100), unstable angina, New York Heart Association grade II or greater CHF, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease. Received other investigational drugs within 28 days PEG, G-tubes, or other percutaneous drains/tubes History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or place the subject at high risk for treatment complications History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the previous 6 months

Sites / Locations

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

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

toxicity
overall response rate
duration of response
overall survival

Full Information

First Posted
March 27, 2006
Last Updated
June 18, 2010
Sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00308529
Brief Title
Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Limited Stage Small Cell Lung Cancer
Official Title
Phase II Study of Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Patients With Limited Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 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 proposed phase II trial will investigate the combination of irinotecan, carboplatin and bevacizumab along with radiation in the treatment of patients with limited-stage SCLC. This study differs from our "maintenance" bevacizumab trial in that bevacizumab will begin with the initial chemotherapy treatment. Irinotecan/platinum regimens are emerging as standard treatments for patients with extensive-stage disease. Adding a novel minimally toxic agent to this regimen up front may further enhance this doublet's efficacy without contributing to toxicity. This trial will be one of the first clinical trials to evaluate a combination of targeted therapy and chemotherapy in the up front treatment of a common solid tumor.
Detailed Description
Eligible patients will receive 4 courses of irinotecan, carboplatin, and bevacizumab. Radiation therapy will begin concurrently with the third course of systemic treatment. The intervals between chemotherapy courses will be 28 days.Patients will be completely restaged approximately 2 weeks after completion of chemotherapy prior to beginning treatment with maintenance bevacizumab. Those with progressive tumor or serious toxicity will come off study. Those with stable disease or objective tumor responses will continue treatment with restaging every 12 weeks for a minimum of 6 cycles (6 months). Induction chemotherapy regimen Irinotecan: 60mg/m2 IV on days 1, 8, and 15 Carboplatin: AUC=4 day 1 only Bevacizumab 10 mg/kg IV days 1, 15 Cycles are repeated every 28 days for four courses Radiation therapy 1.8 Gy, single daily fractions, concurrently with the third course of chemotherapy e to a total dose of 61.2 Gy (34 fractions). Patients obtaining complete remission or near complete remission will also receive prophylactic whole brain radiotherapy, given within one month after all therapy is completed (total dose 24Gy in 2Gy daily fractions). Maintenance Bevacizumab Bevacizumab alone at a dose of 10 mg/kg IV days 1 and 15 each cycle, for a maximum of 6 additional cycles (6 months) with restaging every 12 weeks.

6. Conditions and Keywords

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

7. Study Design

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

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
Intervention Type
Procedure
Intervention Name(s)
Radiation Therapy
Primary Outcome Measure Information:
Title
progression-free survival
Secondary Outcome Measure Information:
Title
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. Limited stage disease ( ECOG performance status 0 or 1. No previous treatment with chemotherapy, radiation therapy, or biologic agents. Measurable disease Adequate bone marrow, liver, kidney function Patients must be able to understand the nature of this study and give written consent. Exclusion Criteria: Age < 18 years History of a prior malignancy within three years with the exception of skin cancer (excluding melanoma), cervical carcinoma in situ, in situ breast carcinoma, or early stage prostate cancer. Women who are pregnant or lactating are ineligible. Men and women of childbearing potential are required to use adequate contraception during this study. History or physical exam evidence of CNS disease (eg seizures not controlled with standard medical therapy, history of stroke) Active infection requiring parenteral antibiotics Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or fine needle aspiration within 7 days of beginning bevacizumab or anticipation of need for major surgical procedure during the course of the study. Full-dose oral or parenteral anticoagulation must be on a stable dosing schedule prior to enrollment. Proteinuria Serious nonhealing wound, ulcer, or bone fracture Evidence of bleeding diathesis or coagulopathy Prior hemoptysis. History of acute myocardial infarction or stroke within 6 months Uncontrolled hypertension (> 150/100), unstable angina, New York Heart Association grade II or greater CHF, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease. Received other investigational drugs within 28 days PEG, G-tubes, or other percutaneous drains/tubes History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or place the subject at high risk for treatment complications History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the previous 6 months
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
19901100
Citation
Spigel DR, Hainsworth JD, Yardley DA, Raefsky E, Patton J, Peacock N, Farley C, Burris HA 3rd, Greco FA. Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol. 2010 Jan 1;28(1):43-8. doi: 10.1200/JCO.2009.24.7353. Epub 2009 Nov 9.
Results Reference
result

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Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Limited Stage Small Cell Lung Cancer

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