Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung Cancers
Condition: Lung Cancer; Untreated Stage IV or Recurrent Squamous Cell Lung Cancers
MeSH terms: Lung Neoplasms; Recurrence
Intervention: albumin-bound paclitaxel; gemcitabine
Intervention MeSH terms: Paclitaxel; Gemcitabine; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Albumin-Bound; Paclitaxel; Gemcitabine; 15-054

Summary:

      The purpose of this study is to test the safety and effectiveness of albumin-bound paclitaxel
      plus gemcitabine in patients with advanced squamous cell lung cancers. The investigators
      would like to determine the percentage of patients with squamous cell lung cancers who
      experience shrinkage of their tumors following treatment with this regimen. This combination
      of drugs is not a standard therapy for patients with squamous cell lung cancers. However,
      each of these drugs, when given alone or with other chemotherapies, is FDA-approved for the
      treatment of this disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed squamous cell lung cancer

          -  Newly diagnosed untreated Stage IV and/or recurrent after adjuvant therapy with
             metastatic disease

          -  Patients previously treated with immune checkpoint inhibitor therapy are eligible

          -  Measurable disease as per RECIST 1.1

          -  Greater than 6 months since receiving neo-adjuvant or adjuvant chemotherapy.

          -  Age ≥ 18 years

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Women of childbearing potential and sexually active men enrolled in the study must
             agree to practice effective contraception method during treatment and for three months
             after completing treatment

          -  Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing
             potential

          -  < Grade 2 pre-existing peripheral neuropathy (per CTCAE)

          -  Marrow and organ function as follows:

          -  ANC ≥ 1500 cells/mm3

          -  Platelets > 100,000 cells/mm3

          -  Hemoglobin>9g/dL

          -  Creatinine clearance ≥ 40mL/min

          -  Bilirubin ≤ 1.5 mg/dL

          -  AST/ALT≤2.5 x upper limit of normal range (ULN),

          -  alkaline phosphatase ≤ 2.5 X upper limit of normal, unless bone metastasis in present
             in the absence of liver metastasis

        Exclusion Criteria:

          -  Prior treatment with albumin-bound paclitaxel or gemcitabine

          -  Prior systemic anticancer therapy for advanced squamous cell lung cancer

          -  Untreated brain metastasis. Patients with treated brain metastases who are off
             steroids are eligible

          -  Peripheral neuropathy greater than grade 1

          -  Malignancies within the past 5 years other than non-melanoma skin cancer or insitu
             cervical cancer status post treatment

          -  Patients with other serious medical illnesses including, ongoing or active infection,
             unstable angina pectoris, or psychiatric illness/social situations that would limit
             compliance with study requirements

          -  Class III or IV congestive heart failure by New York Heart Association