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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525653
• Other study ID #: 15-054
• Status: Completed
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: May 2019

Study information

• Verified date: September 2019
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Untreated Stage IV or Recurrent Squamous Cell Lung Cancers

Intervention

Drug:
• albumin-bound paclitaxel

• gemcitabine

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Miami Cancer Institute Baptist Health South Florida	Miami	Florida
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

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Celgene Corporation, Miami Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participants Evaluated for Toxicity	AE's will be collected, tabulated according to CTCAE version 4.0 and summarized using descriptive statistics.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center