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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
albumin-bound paclitaxel
gemcitabine
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Albumin-Bound, Paclitaxel, Gemcitabine, 15-054

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Miami Cancer Institute Baptist Health South Florida
  • Memorial Sloan Kettering at Basking Ridge
  • Memorial Sloan Kettering Commack
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Rockville Centre
  • Memorial Sloan Kettering Westchester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Albumin-Bound Paclitaxel and Gemcitabine

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Participants Evaluated for Toxicity
AE's will be collected, tabulated according to CTCAE version 4.0 and summarized using descriptive statistics.

Full Information

First Posted
August 14, 2015
Last Updated
December 21, 2020
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Celgene Corporation, Miami Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02525653
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Celgene Corporation, Miami Cancer Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Untreated Stage IV or Recurrent Squamous Cell Lung Cancers
Keywords
Albumin-Bound, Paclitaxel, Gemcitabine, 15-054

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albumin-Bound Paclitaxel and Gemcitabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
albumin-bound paclitaxel
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Participants Evaluated for Toxicity
Description
AE's will be collected, tabulated according to CTCAE version 4.0 and summarized using descriptive statistics.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Paik, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Cancer Institute Baptist Health South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Memorial Sloan Kettering at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Rockville Centre
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Sleepy Hollow
State/Province
New York
ZIP/Postal Code
10591
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31919132
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.
Results Reference
derived
Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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