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BAY 59-8862 in Treating Patients With Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ortataxel
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Measurable disease A CNS lesion cannot be the sole target lesion Must be taxane-resistant as defined by the following criteria: At least 1 prior course (3 weeks of continuous therapy) of a taxane Progressive disease developed either during or within 6 months after therapy No metastatic brain or meningeal tumors unless the following criteria apply: More than 6 months since definitive therapy Negative imaging study within the past 4 weeks Clinically stable with respect to the tumor No concurrent acute steroid therapy or taper Chronic steroids allowed provided dose is stable for 1 month before and after screening radiography PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT and AST no greater than 2.5 times ULN (5 times ULN if liver involvement) No chronic hepatitis B or C Renal Creatinine no greater than 1.5 times ULN Cardiovascular No congestive heart failure No serious cardiac arrhythmias No active coronary disease or ischemia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception HIV negative No active clinically serious infection No history of seizure disorder History of seizures related to brain metastasis allowed if seizure free for the past 2 months No prior hypersensitivity to taxane compounds that was unmanageable with premedication No pre-existing peripheral neuropathy greater than grade 1 No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, and T1) No substance abuse No medical, psychological, or social condition that would preclude study participation or evaluation No condition that is unstable or would jeopardize patient safety and study compliance PRIOR CONCURRENT THERAPY: Biologic therapy More than 3 weeks since prior anticancer immunotherapy More than 3 weeks since prior biologic response modifiers (e.g., filgrastim [G-CSF]) More than 4 months since prior bone marrow transplantation or stem cell rescue No concurrent anticancer immunotherapy Concurrent epoetin alfa allowed if dose is stable for the past 2 months Chemotherapy See Disease Characteristics More than 3 weeks since prior anticancer chemotherapy (6 weeks for mitomycin or nitrosoureas) No more than 2 prior anticancer chemotherapy regimens (adjuvant therapy is not included unless cancer recurred during or within 6 months after completion of adjuvant therapy) No prior oxaliplatin No other concurrent chemotherapy Endocrine therapy See Disease Characteristics Radiotherapy More than 3 weeks since prior radiotherapy No concurrent non-palliative radiotherapy Palliative radiotherapy allowed provided that all of the following criteria are met: No progressive disease No more than 10% of the bone marrow is irradiated Radiation field does not encompass a target lesion Surgery More than 4 weeks since prior surgery No prior organ allograft Other More than 4 weeks since prior investigational drug therapy No concurrent non-conventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements that would interfere with study endpoints No other concurrent investigational drug therapy No other concurrent anticancer therapy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 5, 2003
    Last Updated
    September 23, 2022
    Sponsor
    Roswell Park Cancer Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00054314
    Brief Title
    BAY 59-8862 in Treating Patients With Non-Small Cell Lung Cancer
    Official Title
    An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2002 (undefined)
    Primary Completion Date
    April 2003 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Roswell Park Cancer Institute

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have non-small cell lung cancer.
    Detailed Description
    OBJECTIVES: Determine the overall response rate, including partial and complete response, in patients with taxane-resistant non-small cell lung cancer treated with BAY 59-8862. Determine the overall survival of patients treated with this drug. Determine duration of response and time to progression in patients treated with this drug. Determine the quantitative and qualitative toxic effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive 2-4 additional courses beyond maximal response. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 14-84 patients will be accrued for this study.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ortataxel

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Measurable disease A CNS lesion cannot be the sole target lesion Must be taxane-resistant as defined by the following criteria: At least 1 prior course (3 weeks of continuous therapy) of a taxane Progressive disease developed either during or within 6 months after therapy No metastatic brain or meningeal tumors unless the following criteria apply: More than 6 months since definitive therapy Negative imaging study within the past 4 weeks Clinically stable with respect to the tumor No concurrent acute steroid therapy or taper Chronic steroids allowed provided dose is stable for 1 month before and after screening radiography PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT and AST no greater than 2.5 times ULN (5 times ULN if liver involvement) No chronic hepatitis B or C Renal Creatinine no greater than 1.5 times ULN Cardiovascular No congestive heart failure No serious cardiac arrhythmias No active coronary disease or ischemia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception HIV negative No active clinically serious infection No history of seizure disorder History of seizures related to brain metastasis allowed if seizure free for the past 2 months No prior hypersensitivity to taxane compounds that was unmanageable with premedication No pre-existing peripheral neuropathy greater than grade 1 No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, and T1) No substance abuse No medical, psychological, or social condition that would preclude study participation or evaluation No condition that is unstable or would jeopardize patient safety and study compliance PRIOR CONCURRENT THERAPY: Biologic therapy More than 3 weeks since prior anticancer immunotherapy More than 3 weeks since prior biologic response modifiers (e.g., filgrastim [G-CSF]) More than 4 months since prior bone marrow transplantation or stem cell rescue No concurrent anticancer immunotherapy Concurrent epoetin alfa allowed if dose is stable for the past 2 months Chemotherapy See Disease Characteristics More than 3 weeks since prior anticancer chemotherapy (6 weeks for mitomycin or nitrosoureas) No more than 2 prior anticancer chemotherapy regimens (adjuvant therapy is not included unless cancer recurred during or within 6 months after completion of adjuvant therapy) No prior oxaliplatin No other concurrent chemotherapy Endocrine therapy See Disease Characteristics Radiotherapy More than 3 weeks since prior radiotherapy No concurrent non-palliative radiotherapy Palliative radiotherapy allowed provided that all of the following criteria are met: No progressive disease No more than 10% of the bone marrow is irradiated Radiation field does not encompass a target lesion Surgery More than 4 weeks since prior surgery No prior organ allograft Other More than 4 weeks since prior investigational drug therapy No concurrent non-conventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements that would interfere with study endpoints No other concurrent investigational drug therapy No other concurrent anticancer therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nithya Ramnath, MD
    Organizational Affiliation
    Roswell Park Cancer Institute
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    BAY 59-8862 in Treating Patients With Non-Small Cell Lung Cancer

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