Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung Cancers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Trial of Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung Cancers

Conditions
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Lung Cancer, Untreated Stage IV or Recurrent Squamous Cell Lung Cancers

Intervention / Treatment
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* Drug: albumin-bound paclitaxel
* Drug: gemcitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albumin-Bound Paclitaxel and Gemcitabine<br>During each 21-day cycle, albumin-bound paclitaxel at 100mg/mg2 over 120 minutes and gemcitabine at 1000mg/m2 over 30 minutes will be given intravenously on days 1 and 8 of each 21 day cycle. Treatment will continue until disease progression or intolerable side effects. After the 4th cycle of treatment, patients will have the option of discontinuing gemcitabine and proceeding with weekly albumin-bound paclitaxel as maintenance therapy. | Drug: albumin-bound paclitaxel<br> <br> Drug: gemcitabine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | defined as the percentage of patients with complete or partial responses based on RECIST 1.1, at any time prior to disease progression, out of all evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Evaluated for Toxicity | AE's will be collected, tabulated according to CTCAE version 4.0 and summarized using descriptive statistics. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Albumin-Bound, Paclitaxel, Gemcitabine, 15-054