NCT02525653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 lung-cancer

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

May 8, 2020

Completed
Last Updated

January 12, 2021

Status Verified

September 1, 2019

Enrollment Period

3.8 years

First QC Date

August 14, 2015

Results QC Date

April 13, 2020

Last Update Submit

December 21, 2020

Conditions

Lung CancerUntreated Stage IV or Recurrent Squamous Cell Lung Cancers

Keywords

Albumin-BoundPaclitaxelGemcitabine15-054

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Participants Evaluated for Toxicity

    1 year

Study Arms (1)

Albumin-Bound Paclitaxel and Gemcitabine

EXPERIMENTAL

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.

Drug: albumin-bound paclitaxelDrug: gemcitabine

Interventions

albumin-bound paclitaxelDRUG
Albumin-Bound Paclitaxel and Gemcitabine
gemcitabineDRUG
Albumin-Bound Paclitaxel and Gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Miami Cancer Institute Baptist Health South Florida

Miami, Florida, 33143, United States

Location

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, United States

Location

Memorial Sloan Kettering Westchester

Sleepy Hollow, New York, 10591, United States

Location

Related Publications (1)

  • 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.

    PMID: 31919132DERIVED

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Albumin-Bound PaclitaxelGemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Dr. Paul Paik, MD
Organization
Memorial Sloan Kettering Cancer Center
paikp@mskcc.org
646-608-3759

Study Officials

  • Paul Paik, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 17, 2015

Study Start

August 1, 2015

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

January 12, 2021

Results First Posted

May 8, 2020

Record last verified: 2019-09

Locations

US(6)