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Active Clinical Trials: Lung- Non-Small Cell Lung Cancer

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ProtocolTitle
NCCTG-N0321Phase I/II Study of PS-341 in Combination with Paclitaxel, Carboplatin, and Concurrent Thoracic Radiation Therapy for Non-small Cell Lung Cancer (NSCLC) (1156)
  • Eligibility: click to view information

    **08/07/07: Phase I is temporarily suspended-accrual for the first cohort of patients at dose level 4 has been met.**

    STUDY DRUG: Provided- PS-341 pg 38
    1) Histo or cyto confirmed NSCLC
    2) Must have measureable disease
    3) None mets NSCLC requiring radiation
    4) ECOG PS 0-1
    5) Radiation Oncologist confirmed eligibility
    6) No Prior radiation to the chest
    7) no systemic chemo

  • HIPAA Forms: N0321 HIPAA
  • Consent Forms: N0321 Consent
SWOG-S0709A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with Performance Status 2 (PS-2) Selected by Serum Proteomics. (1649)
  • Eligibility: click to view information

    DISEASE CHARACTERISTICS:
    Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following subtypes:
    Adenocarcinoma
    Large cell carcinoma
    Squamous cell carcinoma
    Unspecified
    Newly diagnosed primary disease OR recurrent disease after prior surgery and/or radiotherapy, meeting 1 of the following staging criteria:

    Selected stage IIIB disease (T4 [secondary to malignant pleural effusion only], any N, M0)
    Stage IV disease (any T, any N, M1 [distant metastases present])
    Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical exam, or nuclear scan

    The CT scan from a combined PET/CT scan may only be used to document nonmeasurable disease
    Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
    Shows evidence of EGFR tyrosine kinase inhibitor therapy benefit (i.e., "proteomics positive") prior to study registration
    No known brain metastases by CT scan or MRI of the brain
    PATIENT CHARACTERISTICS:

    Zubrod performance status 2
    ANC e 1,500/mm³
    Platelet count e 1,000/mm³
    Serum bilirubin normal
    SGOT or SGPT normal
    Serum creatinine d 2 times upper limit of normal OR creatinine clearance e 50 mL/min
    Willing to provide prior smoking history as requested on the prestudy form
    No gastrointestinal (GI) tract disease resulting in an inability to take enteral medication
    No malabsorption syndrome or requirement for IV alimentation
    No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
    No significant history of cardiac disease, including any of the following:

    Uncontrolled high blood pressure
    Unstable angina
    Congestive heart failure
    Myocardial infarction within the past 6 months
    Cardiac ventricular arrhythmia requiring medication
    No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
    Not pregnant or nursing
    Fertile patients must use effective contraception
    PRIOR CONCURRENT THERAPY:

    See Disease Characteristics
    At least 3 weeks since prior radiotherapy or surgery (thoracic or other major surgery) and recovered
    At least 1 year since prior adjuvant chemotherapy
    No prior systemic hormonal therapy, chemotherapy, or biological therapy for advanced NSCLC
    No prior EGFR inhibitors
    No prior surgical procedures affecting absorption
    No concurrent major surgery


  • Consent Forms: S0709 Consent
SWOG-S0819A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) (1728)
  • Eligibility: click to view information

    **see section 19.6, sub section 2.0, regarding mandatory electronic scan submission & to download computer application**

    DISEASE CHARACTERISTICS:

    Histologically or cytologically confirmed non-small cell lung cancer, including any of the following subtypes:

    Adenocarcinoma
    Large cell carcinoma
    Squamous cell carcinoma
    Unspecified
    Newly diagnosed stage IV disease OR recurrent disease after prior surgery and/or irradiation

    Patients with additional lesions in an ipsilateral non-primary lobe without M1a or M1b disease are not considered to have stage IV disease and are not eligible
    Measurable or non-measurable disease documented by CT scan or MRI

    Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
    Measurable disease must be outside a previously irradiated field or must have progressed
    Brain metastases allowed provided they have been controlled for = 2 months after completion of treatment and there is no residual neurological dysfunction while off corticosteroids
    PATIENT CHARACTERISTICS:

    Zubrod performance status 0-1
    ANC = 1,500/mm^3
    Platelet count = 100,000/mm^3
    Hemoglobin = 9 g/dL
    Serum creatinine normal
    Creatinine clearance = 50 mL/min
    Urine protein:creatinine ratio = 0.5 OR 24-hour urine protein < 1,000 mg
    Serum bilirubin = 2 times upper limit of normal (ULN) (= 5 times ULN for patients with liver metastases)
    SGOT OR SGPT = 2 times ULN (= 5 times ULN for patients with liver metastases)
    Not pregnant or nursing
    Fertile patients must use effective contraception during and for 3-6 months after completion of study treatment
    Agrees to submission of specimens for EGFR FISH testing and other translational medicine studies
    Willing to provide prior smoking history
    No significant traumatic injury within the past 28 days
    No symptomatic sensory neuropathy = grade 2 as assessed by NCI CTCAE v3.0
    No documented presence of human anti-mouse antibodies
    No documented evidence of acute hepatitis
    No active or uncontrolled infection
    None of the following within the past 6 months:

    Cerebrovascular accident, myocardial infarction, or unstable angina
    Uncontrolled hypertension
    NYHA class II-IV congestive heart failure
    Serious cardiac arrhythmia requiring medication
    Clinically significant peripheral vascular disease
    No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (e.g., trastuzumab [Herceptin®] or epoetin alpha)
    No other prior malignancy except for any of the following:

    Adequately treated basal cell or squamous cell skin cancer
    In situ cervical cancer
    Adequately treated stage I or II cancer from which the patient is currently in complete remission
    Any other cancer from which the patient has been disease-free for 5 years
    PRIOR CONCURRENT THERAPY:

    See Disease Characteristics
    Prior radiotherapy allowed provided patients have recovered from all associated toxicities at the time of study registration
    No prior chemotherapy, cetuximab, gefitinib, erlotinib, or other investigational agents that target the EGFR pathway
    No prior VEGF-related agents
    No prior chimerized or murine monoclonal antibody therapy
    At least 28 days since prior surgery (thoracic or other major surgeries) or open biopsy and recovered
    More than 7 days since prior core biopsy
    No concurrent major surgical procedures


  • Consent Forms: S0819 NCI Consent
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