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Liposomal SN-38 in Treating Patients With Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
liposomal SN-38
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent small cell lung cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer meeting 1 of the following criteria: Previously untreated disease Extensive stage disease, as defined by any of the following: Metastatic disease outside of the chest Contralateral supraclavicular or contralateral hilar nodes that cannot be included in a single radiation port Malignant pleural effusion Previously treated disease Limited or extensive stage disease Measurable disease Lesions ≥ 1 cm and < 2 cm must be measured by spiral CT scan for pre- and post-treatment tumor assessment UGT1A1*28 genotype wt/wt (6/6 promoter TA repeats) OR wt/*28 (6/7 promoter TA repeats) No *28/*28 (7/7 promoter TA repeats) genotype No mixed histology No uncontrolled CNS metastasis Previously treated, stable CNS metastasis allowed No superior vena cava syndrome No malignant pericardial effusion No near obstruction of the trachea or main stem bronchi PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Total bilirubin < 1.5 times upper limit of normal (ULN) OR Direct bilirubin normal Renal Creatinine < 1.5 times ULN Cardiovascular No unstable angina pectoris No uncontrolled congestive heart failure No myocardial infarction within the past 3 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study participation No syndrome of inappropriate antidiuretic hormone secretion No ectopic adrenocorticotrophic syndrome No Lambert-Eaton myasthenic syndrome No other severe paraneoplastic syndrome No active infection requiring oral or parenteral antibiotics No other life threatening disease No other malignancy except basal cell or squamous cell skin cancer, localized prostate cancer, superficial bladder cancer, or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent filgrastim (G-CSF) during course 1 of study treatment Chemotherapy No more than 1 prior chemotherapy regimen for this malignancy Prior cyclophosphamide, doxorubicin, and vincristine (CAV) alternating with etoposide and cisplatin (EP) allowed More than 21 days since prior chemotherapy Endocrine therapy Not specified Radiotherapy More than 14 days since prior radiotherapy Concurrent palliative radiotherapy allowed except radiotherapy to a solitary measured index lesion Surgery More than 21 days since prior major surgery Other No other concurrent treatment for this malignancy No other concurrent investigational treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    liposomal SN-38

    Arm Description

    Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response or patients with stable disease (SD) who were previously treated before study enrollment receive up to 4 additional courses of treatment. Patients with CNS-only disease progression receive whole brain radiotherapy (WBRT). After completion of WBRT, these patients also receive up to 4 additional courses of treatment. Patients with disease progression to sites other than the CNS or patients with SD who were previously untreated before study enrollment are removed from the study. Quality of life is assessed at baseline, before each treatment course, and then annually for 3 years. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years.

    Outcomes

    Primary Outcome Measures

    Tumor response measured by number of responses

    Secondary Outcome Measures

    Time to disease progression
    Survival time
    Change in quality of life (QOL) score over time

    Full Information

    First Posted
    March 3, 2005
    Last Updated
    July 19, 2016
    Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00104754
    Brief Title
    Liposomal SN-38 in Treating Patients With Small Cell Lung Cancer
    Official Title
    Phase II Trial of Liposome Encapsulated SN38 (LE-SN38) in the Treatment of Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients with small cell lung cancer.
    Detailed Description
    OBJECTIVES: Determine the response rate in patients with small cell lung cancer treated with SN-38 liposome that is dosed according to a UGT1A1-specific genotype. Determine the toxicity of this drug in these patients. Determine, preliminarily, overall and progression-free survival of patients treated with this drug. Determine the quality of life of patients treated with this drug. Correlate UGT1A1-specific haplotypes with toxicity of this drug in these patients. Correlate UGT1A1-specific haplotypes with outcomes of patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to length of time since prior treatment (previously untreated disease OR chemosensitive disease and ≥ 3 months since prior treatment vs refractory disease OR chemoresistant disease and < 3 months since prior treatment). Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response or patients with stable disease (SD) who were previously treated before study enrollment receive up to 4 additional courses of treatment. Patients with CNS-only disease progression receive whole brain radiotherapy (WBRT). After completion of WBRT, these patients also receive up to 4 additional courses of treatment. Patients with disease progression to sites other than the CNS or patients with SD who were previously untreated before study enrollment are removed from the study. Quality of life is assessed at baseline, before each treatment course, and then annually for 3 years. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: Approximately 73 patients (40 for stratum I and 33 for stratum II) will be accrued for this study within 16-19 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer
    Keywords
    extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent small cell lung cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    None (Open Label)
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    liposomal SN-38
    Arm Type
    Experimental
    Arm Description
    Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response or patients with stable disease (SD) who were previously treated before study enrollment receive up to 4 additional courses of treatment. Patients with CNS-only disease progression receive whole brain radiotherapy (WBRT). After completion of WBRT, these patients also receive up to 4 additional courses of treatment. Patients with disease progression to sites other than the CNS or patients with SD who were previously untreated before study enrollment are removed from the study. Quality of life is assessed at baseline, before each treatment course, and then annually for 3 years. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years.
    Intervention Type
    Drug
    Intervention Name(s)
    liposomal SN-38
    Primary Outcome Measure Information:
    Title
    Tumor response measured by number of responses
    Time Frame
    Up to 3 years
    Secondary Outcome Measure Information:
    Title
    Time to disease progression
    Time Frame
    Up to 3 years
    Title
    Survival time
    Time Frame
    Up to 3 years
    Title
    Change in quality of life (QOL) score over time
    Time Frame
    Up to 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer meeting 1 of the following criteria: Previously untreated disease Extensive stage disease, as defined by any of the following: Metastatic disease outside of the chest Contralateral supraclavicular or contralateral hilar nodes that cannot be included in a single radiation port Malignant pleural effusion Previously treated disease Limited or extensive stage disease Measurable disease Lesions ≥ 1 cm and < 2 cm must be measured by spiral CT scan for pre- and post-treatment tumor assessment UGT1A1*28 genotype wt/wt (6/6 promoter TA repeats) OR wt/*28 (6/7 promoter TA repeats) No *28/*28 (7/7 promoter TA repeats) genotype No mixed histology No uncontrolled CNS metastasis Previously treated, stable CNS metastasis allowed No superior vena cava syndrome No malignant pericardial effusion No near obstruction of the trachea or main stem bronchi PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Total bilirubin < 1.5 times upper limit of normal (ULN) OR Direct bilirubin normal Renal Creatinine < 1.5 times ULN Cardiovascular No unstable angina pectoris No uncontrolled congestive heart failure No myocardial infarction within the past 3 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study participation No syndrome of inappropriate antidiuretic hormone secretion No ectopic adrenocorticotrophic syndrome No Lambert-Eaton myasthenic syndrome No other severe paraneoplastic syndrome No active infection requiring oral or parenteral antibiotics No other life threatening disease No other malignancy except basal cell or squamous cell skin cancer, localized prostate cancer, superficial bladder cancer, or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent filgrastim (G-CSF) during course 1 of study treatment Chemotherapy No more than 1 prior chemotherapy regimen for this malignancy Prior cyclophosphamide, doxorubicin, and vincristine (CAV) alternating with etoposide and cisplatin (EP) allowed More than 21 days since prior chemotherapy Endocrine therapy Not specified Radiotherapy More than 14 days since prior radiotherapy Concurrent palliative radiotherapy allowed except radiotherapy to a solitary measured index lesion Surgery More than 21 days since prior major surgery Other No other concurrent treatment for this malignancy No other concurrent investigational treatment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James R. Jett, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Liposomal SN-38 in Treating Patients With Small Cell Lung Cancer

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