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Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Irinotecan
Carboplatin
Bevacizumab
Radiation
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: To be included in this study, you must meet the following criteria: Small cell lung cancer, confirmed by biopsy. Limited stage disease after standard evaluation. Able to perform activities of daily living without assistance. No previous treatment with chemotherapy, radiation therapy, or biologics. Measurable or evaluable disease Adequate bone marrow, liver and kidney function Able to understand the nature of this study and give written consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years History of previous malignancies Women pregnant or lactating History or physical exam evidence of central nervous system disease) Active infection requiring intravenous antibiotics Full-dose anticoagulation or thrombolytic therapy within 10 days Proteinuria. Serious nonhealing wound, ulcer, or bone fracture Evidence if bleeding diathesis or coagulopathy History of heart attack within 6 months. Uncontrolled cardiovascular disease PEG or G-tube History of other serious disease Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).

    Outcomes

    Primary Outcome Measures

    Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
    Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.

    Secondary Outcome Measures

    2-Year Progression-free Survival (PFS)
    Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry.
    Overall Response Rate
    Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    June 29, 2016
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Genentech, Inc., Pharmacia and Upjohn
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193375
    Brief Title
    Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer
    Official Title
    Phase II Trial of Concurrent Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab (Avastin) in the Treatment of Patients With Limited Stage Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2003 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    May 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Genentech, Inc., Pharmacia and Upjohn

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with limited stage small cell lung cancer.
    Detailed Description
    Upon determination of eligibility, all patients will be receive: Irinotecan + Carboplatin + Radiation Therapy + Bevacizumab Patients will receive 4 courses of irinotecan/carboplatin. Radiation therapy will begin concurrently with the third course of chemotherapy. The intervals between chemotherapy courses will be 21 days except for the interval between the third and fourth courses (during radiation therapy), which will be 28 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
    Intervention Type
    Drug
    Intervention Name(s)
    Irinotecan
    Other Intervention Name(s)
    Camptosar
    Intervention Description
    50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Other Intervention Name(s)
    Paraplatin
    Intervention Description
    AUC 5
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab
    Other Intervention Name(s)
    Avastin
    Intervention Description
    10mg/kg IV every 2 weeks for 10 doses starting week 16
    Intervention Type
    Radiation
    Intervention Name(s)
    Radiation
    Primary Outcome Measure Information:
    Title
    Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
    Description
    Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    2-Year Progression-free Survival (PFS)
    Description
    Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry.
    Time Frame
    24 months
    Title
    Overall Response Rate
    Description
    Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
    Time Frame
    18 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be included in this study, you must meet the following criteria: Small cell lung cancer, confirmed by biopsy. Limited stage disease after standard evaluation. Able to perform activities of daily living without assistance. No previous treatment with chemotherapy, radiation therapy, or biologics. Measurable or evaluable disease Adequate bone marrow, liver and kidney function Able to understand the nature of this study and give written consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years History of previous malignancies Women pregnant or lactating History or physical exam evidence of central nervous system disease) Active infection requiring intravenous antibiotics Full-dose anticoagulation or thrombolytic therapy within 10 days Proteinuria. Serious nonhealing wound, ulcer, or bone fracture Evidence if bleeding diathesis or coagulopathy History of heart attack within 6 months. Uncontrolled cardiovascular disease PEG or G-tube History of other serious disease Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John D. Hainsworth, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    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
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    Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer

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