Clinical trial NCT02525653: Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung Cancers
Official title: A Phase II Trial of Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Untreated Stage IV or Recurrent Squamous Cell Lung Cancers
Keywords: Albumin-Bound
Paclitaxel
Gemcitabine
15-054
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
name: Miami Cancer Institute
First posted: 2015-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: 1 year
Secondary outcomes:
measure: Participants Evaluated for Toxicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cancer Institute Baptist Health South Florida
state: Florida
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre
state: New York
city: Sleepy Hollow
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Paul Paik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paik PK, Kim RK, Ahn L, Plodkowski AJ, Ni A, Donoghue MTA, Jonsson P, Villalona-Calero M, Ng K, McFarland D, Fiore JJ, Iqbal A, Eng J, Kris MG, Rudin CM. A Phase II Trial of Albumin-Bound Paclitaxel and Gemcitabine in Patients with Newly Diagnosed Stage IV Squamous Cell Lung Cancers. Clin Cancer Res. 2020 Apr 15;26(8):1796-1802. doi: 10.1158/1078-0432.CCR-19-3060. Epub 2020 Jan 9.