Clinical Trials /

Single Agent Versus Combination Chemotherapy to Treat High-risk Elderly With Non-small Cell Lung Cancer

NCT02590003

Description:

This study will enroll elderly patients with advanced non-small cell lung cancer who are at high risk of developing chemotherapy toxicity (side effects). Patients will receive treatment with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single agent nab-paclitaxel of chemotherapy. Response to treatment and treatment toxicity will be compared in the two treatment groups to determine the best treatment strategy for this group of patients.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Single Agent Versus <span class="go-doc-concept go-doc-intervention">Combination Chemotherapy</span> to Treat High-risk Elderly With Non-small Cell Lung Cancer

Title

  • Brief Title: Single Agent Versus Combination Chemotherapy to Treat High-risk Elderly With Non-small Cell Lung Cancer
  • Official Title: A Randomized Phase II Trial of Combination Versus Single Agent Chemotherapy in High-risk Elderly Patients With Advanced Non-small Cell Lung Cancer
  • Clinical Trial IDs

    NCT ID: NCT02590003

    ORG ID: 1403013529

    Trial Conditions

    Carcinoma, Non-small Cell Lung

    Trial Interventions

    Drug Synonyms Arms
    Carboplatin Platinum-based doublet chemotherapy
    Nab-paclitaxel Platinum-based doublet chemotherapy, Single agent chemotherapy

    Trial Purpose

    This study will enroll elderly patients with advanced non-small cell lung cancer who are at
    high risk of developing chemotherapy toxicity (side effects). Patients will receive
    treatment with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel
    or single agent nab-paclitaxel of chemotherapy. Response to treatment and treatment toxicity
    will be compared in the two treatment groups to determine the best treatment strategy for
    this group of patients.

    Detailed Description

    The primary objective of this trial is to compare the treatment failure-free survival rate
    in high-risk elderly patients, identified by geriatric assessment, treated with either a
    platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single agent
    nab-paclitaxel in advanced non-small cell lung cancer. Treatment failure-free survival is
    the most appropriate primary outcome as it captures excessive toxicity due to chemotherapy
    in addition to death and disease progression.

    The secondary objectives are to evaluate grade 3-5 toxicities, overall response rate,
    progression free survival, symptom assessment, and overall survival between the two
    randomization arms.

    Trial Arms

    Name Type Description Interventions
    Platinum-based doublet chemotherapy Experimental Carboplatin AUC 5 30 minute infusion IV on day 1 Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle Carboplatin, Nab-paclitaxel
    Single agent chemotherapy Active Comparator -Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle Nab-paclitaxel

    Eligibility Criteria

    Inclusion Criteria:

    1. Patient able and willing to comply with study procedures as per protocol, including
    the geriatric assessment at the time of study enrollment.

    2. Patient able to understand and willing to sign and date the written voluntary
    informed consent form (ICF) at screening visit prior to any protocol-specific
    procedures.

    3. Patients must have histological or cytological confirmed primary non-small cell lung
    cancer (adenocarcinoma, large cell carcinoma, squamous, or unspecified). Disease must
    be stage IV Non-Small Cell Lung Cancer (NSCLC). Disease may be either newly diagnosed
    or recurrent after previous surgery and/or irradiation.

    4. Patients may have measurable or non-measurable disease documented by CT or MRI. The
    CT from a combined PET/CT may be used to document only non-measurable disease.
    Measurable disease must be assessed within 30 days prior to registration per response
    evaluation criteria in solid tumors (RECIST) v1.1. Pleural effusions, ascites and
    laboratory parameters are not acceptable as the only evidence of disease. Non-
    measurable disease must be assessed within 30 days prior to registration. All disease
    must be assessed and documented on the Baseline Tumor Assessment Form.

    5. Prior chemotherapy for curative intent is permitted providing the cytotoxic
    chemotherapy was completed 12 months prior to enrollment. Patients must have a CT or
    MRI scan of the brain to evaluate for CNS disease within 30 days prior to
    registration. Patient must not have brain metastases unless: (1) metastases have been
    treated and have remained controlled for at least two weeks following treatment, AND
    (2) patient has no residual neurological dysfunction off corticosteroids for at least
    1 day. Any radiation therapy completed prior to chemotherapy, except gamma-knife
    radiosurgery, 1 week prior to chemotherapy.

    6. Age >70 years of age at time of signing of the informed consent form.

    7. Life expectancy of greater than 12 weeks.

    8. ECOG performance status 0-2 (See Appendix A)

    9. Patients must have a comprehensive geriatric assessment and chemotherapy toxicity
    assessment score between 10-17 (See Appendix B, D)

    10. Patients must have normal organ and marrow function as defined below:

    - Leukocytes >3,000/mcL

    - ANC > 1,500 cells/mm3 Hemoglobin > 9.0g/dL

    - Platelets >100,000 cells/mm3

    - Total bilirubin < 1.5 mg/dL (unless there is a known history of Gilberts
    Syndrome).

    - AST(SGOT)/ALT(SGPT) 2.5 X institutional upper limit of normal

    - Alkaline phosphatase < 2.5 X upper limit of normal in the absence of liver or
    bone metastasis, or 5.0 upper limit of normal range if bone or liver
    metastases

    - Creatinine clearance >25 mL/min or creatinine <1.5 mg/dL

    11. HIV-positive patients on combination antiretroviral therapy are eligible if they have
    been on ARVs for 6 months and undetectable viral loads.

    12. Patients must not have documented evidence of acute hepatitis or have an active or
    uncontrolled infection.

    13. No other prior malignancy is allowed except for 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, or
    any other cancer from which the patient has been disease-free for 5 years.

    14. Ability to understand and the willingness to sign a written informed consent document
    in English or a Spanish consent "short form". If language other than English or
    Spanish, then interpreter will be used to sign English consent form.

    15. Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)

    Exclusion Criteria:

    1. Patients who have had palliative chemotherapy prior to entering the study <12 months
    from enrollment or those who have not recovered from adverse events due to agents
    administered more than 4 weeks earlier.

    2. Patients may not be receiving any other investigational agents or have received
    immunotherapy.

    3. Known EGFR or ALK mutated disease (molecular testing not required prior to study
    entry)

    4. History of allergic reactions attributed to compounds of similar chemical or biologic
    composition to carboplatin, or nab-paclitaxel.

    5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
    infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
    arrhythmia, or psychiatric illness/social situations that would limit compliance with
    study requirements.

    6. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology
    Criteria for Adverse Events v4.0)

    7. Evidence of active brain metastases, including leptomeningeal involvement (prior
    evidence of brain metastasis are permitted only if treated and stable and off therapy
    for 2 weeks prior to signing Informed consent form. Magnetic Resonance Imaging of
    the brain (or Computed Tomography scan w/contrast) is preferred for diagnosis.

    Minimum Eligible Age: 71 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Treatment failure-free survival

    Secondary Outcome Measures

    overall response rate

    progression-free survival

    overall survival

    grade 3-5 adverse events

    Symptom Assessment (measured by FACT-L Symptom Assessment Scale)

    Symptom Assessment (measured by FACT-L Symptom Assessment Scale)

    Symptom Assessment (measured by FACT-L Symptom Assessment Scale)

    Trial Keywords