Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung Cancers
NCT ID: NCT02525653
Last Updated: 2021-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2015-08-31
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Albumin-Bound Paclitaxel and Gemcitabine
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.
albumin-bound paclitaxel
gemcitabine
Interventions
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albumin-bound paclitaxel
gemcitabine
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Miami Cancer Institute
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Paul Paik, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Miami Cancer Institute Baptist Health South Florida
Miami, Florida, United States
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, United States
Memorial Sloan Kettering Westchester
Sleepy Hollow, New York, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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15-054
Identifier Type: -
Identifier Source: org_study_id
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