CompletedPhase 2NCT02525653

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

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.

Checked against the public recordLast updated Jan 12, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations6
SponsorMemorial Sloan Kettering Cancer Center
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Memorial Sloan Kettering Cancer Center
Interventions being studied
Drug: albumin-bound paclitaxel; Drug: gemcitabine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Miami Cancer Institute Baptist Health South FloridaMiami, Florida
  • Memorial Sloan Kettering at Basking RidgeBasking Ridge, New Jersey
  • Memorial Sloan Kettering CommackCommack, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Memorial Sloan Kettering Rockville CentreRockville Centre, New York
  • Memorial Sloan Kettering WestchesterSleepy Hollow, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 12, 2021. Always confirm current availability with the study team.

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