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Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III or Stage IV Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
docetaxel
gemcitabine hydrochloride
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed stage IIIB or IV non-small cell lung cancer, including any of the following types: Squamous cell carcinoma Adenocarcinoma, including bronchoalveolar cell adenocarcinoma Large cell anaplastic carcinoma, including giant and clear cell carcinomas Histologic or cytologic documentation of recurrence is required Measurable or evaluable disease, defined as any mass reproducibly measurable in 2 perpendicular diameters by physical examination or imaging The following lesions are not considered measurable or evaluable: Bone disease only Pleural or pericardial effusions Previously irradiated lesions, unless subsequent progression is documented CNS metastases allowed provided the patient undergoes at least 2 weeks of radiotherapy prior to study entry PATIENT CHARACTERISTICS: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test CALGB performance status ≤ 1 Life expectancy ≥ 3 months Granulocyte count > 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Creatinine ≤ 2 times normal Bilirubin normal SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase ≤ 1.5 times ULN OR Alkaline phosphatase 4 times ULN and SGOT and/or SGPT normal Ejection fraction normal by ECHO or MUGA No history of congestive heart failure No psychiatric illness that would preclude study compliance No serious medical or psychiatric illness that would preclude giving informed consent or limit survival to < 3 months No active uncontrolled bacterial, fungal, or viral infection No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or breast, basal cell or squamous carcinoma of the skin, or other surgically resected non-recurrent primary tumor not treated with adjuvant radiotherapy or chemotherapy No pre-existing peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: At least 2 weeks since prior major surgery and recovered from acute effects At least 2 weeks since prior palliative radiotherapy and recovered from acute toxic effects Any persistent toxicity (e.g., alopecia or hyperpigmentation) not associated with clinical morbidity allowed No prior chemotherapy No concurrent cranial or thoracic radiation therapy No concurrent cytotoxic or hormonal therapy Concurrent palliative radiotherapy allowed for relief of localized pain and obstruction

Sites / Locations

    Outcomes

    Primary Outcome Measures

    patient response rate to weekly taxotere and gemcitabine

    Secondary Outcome Measures

    Evaluate toxicity of weekly Taxotere and Gemcitabine

    Full Information

    First Posted
    January 16, 2006
    Last Updated
    January 18, 2017
    Sponsor
    Wake Forest University Health Sciences
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00278460
    Brief Title
    Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III or Stage IV Non-Small Cell Lung Cancer
    Official Title
    A Phase II Study of Taxotere and Gemcitabine for Stages III-B and IV Non-Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2000 (undefined)
    Primary Completion Date
    February 2006 (Actual)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.
    Detailed Description
    OBJECTIVES: Primary Determine the response rate of patients with recurrent stage IIIB and IV non-small cell lung cancer treated with gemcitabine hydrochloride and docetaxel. Determine the overall and progression-free survival of patients treated with this regimen. Determine the toxic effects of this regimen in these patients. Secondary Determine the duration of response in patients treated with this regimen. OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for survival. PROJECTED ACCRUAL: A total of 51 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
    stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer, recurrent non-small cell lung cancer, squamous cell 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
    49 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    docetaxel
    Intervention Description
    40 milligrams per meter squared infused over 30 minutes on day 1 and 8, repeated every 21 days
    Intervention Type
    Drug
    Intervention Name(s)
    gemcitabine hydrochloride
    Intervention Description
    800 milligrams per meter squared intraveneously for two consecutive weeks followe by one week of no treatment then repeated.
    Primary Outcome Measure Information:
    Title
    patient response rate to weekly taxotere and gemcitabine
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Evaluate toxicity of weekly Taxotere and Gemcitabine
    Time Frame
    6 weeks

    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 confirmed stage IIIB or IV non-small cell lung cancer, including any of the following types: Squamous cell carcinoma Adenocarcinoma, including bronchoalveolar cell adenocarcinoma Large cell anaplastic carcinoma, including giant and clear cell carcinomas Histologic or cytologic documentation of recurrence is required Measurable or evaluable disease, defined as any mass reproducibly measurable in 2 perpendicular diameters by physical examination or imaging The following lesions are not considered measurable or evaluable: Bone disease only Pleural or pericardial effusions Previously irradiated lesions, unless subsequent progression is documented CNS metastases allowed provided the patient undergoes at least 2 weeks of radiotherapy prior to study entry PATIENT CHARACTERISTICS: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test CALGB performance status ≤ 1 Life expectancy ≥ 3 months Granulocyte count > 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Creatinine ≤ 2 times normal Bilirubin normal SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase ≤ 1.5 times ULN OR Alkaline phosphatase 4 times ULN and SGOT and/or SGPT normal Ejection fraction normal by ECHO or MUGA No history of congestive heart failure No psychiatric illness that would preclude study compliance No serious medical or psychiatric illness that would preclude giving informed consent or limit survival to < 3 months No active uncontrolled bacterial, fungal, or viral infection No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or breast, basal cell or squamous carcinoma of the skin, or other surgically resected non-recurrent primary tumor not treated with adjuvant radiotherapy or chemotherapy No pre-existing peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: At least 2 weeks since prior major surgery and recovered from acute effects At least 2 weeks since prior palliative radiotherapy and recovered from acute toxic effects Any persistent toxicity (e.g., alopecia or hyperpigmentation) not associated with clinical morbidity allowed No prior chemotherapy No concurrent cranial or thoracic radiation therapy No concurrent cytotoxic or hormonal therapy Concurrent palliative radiotherapy allowed for relief of localized pain and obstruction
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antonius A. Miller, MD
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III or Stage IV Non-Small Cell Lung Cancer

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