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Cisplatin and Nab-paclitaxel for (N2) Defined NSCLC (LCCC1407)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276560
Recruitment Status : Terminated (This study was terminated due to lack of funding.)
First Posted : October 28, 2014
Results First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:
The purpose of this research study is to determine whether giving cisplatin and nab-paclitaxel before surgery will reduce the presence of disease in certain areas of the lung at the time of surgery.

Condition or disease Intervention/treatment Phase
Stage IIIA Non-Small Cell Lung Cancer Drug: Neoadjuvant Cisplatin, nab-paclitaxel Drug: Adjuvant Cisplatin,nab-paclitaxel Drug: Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine Phase 2

Detailed Description:

Objectives

To estimate the rate of N2 nodal clearance at time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin and surgery.

Estimate response rate and complete response rate in non-small cell lung cancer (NSCLC) after 3 cycles of neoadjuvant nab-paclitaxel plus cisplatin

Estimate complete pathological response of primary tumor and lymph nodes at the time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin

Estimate disease free survival for all patients who undergo surgery and also stratified by nodal clearance

Patients will be assigned to receive three (3) cycles of cisplatin (mg/m2) and nab-paclitaxel (125 mg/m2). Surgery will then be conducted per standard of care.

Approximately 4-12 weeks after the surgical resection, patients will receive one of three available treatment regimens based on the results of the surgical reports, which include: Two four week cycles of therapy of Cisplatin and Nab-paclitaxel; Four three-week cycles of Cisplatin and Pemetrexed, or four three-week cycles of Cisplatin and Gemcitabine

Thirty (30) days after treatment ends, subjects will be followed for any ongoing serious adverse events, if necessary, and every 3-6 months thereafter for two years.

After the two years of follow-up, subjects will be followed for survival and disease status

Estimate overall survival for entire group and stratified by nodal clearance

To estimate event free survival (EFS)

Estimate time to distant recurrence and time to local recurrence following total study procedures

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Multicenter Trial of Neoadjuvant Cisplatin and Nab-paclitaxel for (N2) Defined Stage IIIA Non-Small Cell Lung Cancer (NSCLC)
Study Start Date : January 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neoadjuvant Cisplatin,nab-paclitaxel
Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care
Drug: Neoadjuvant Cisplatin, nab-paclitaxel
Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery
Other Names:
  • Platinol
  • Abraxane

Experimental: Adjuvant Cisplatin,nab-paclitaxel
Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2
Drug: Adjuvant Cisplatin,nab-paclitaxel
Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2
Other Names:
  • Platinol
  • Abraxane

Cisplatin+pemetrexed or gemcitabine
Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4
Drug: Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine
Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4
Other Names:
  • Platinol
  • Alimta
  • Gemzar




Primary Outcome Measures :
  1. Rate of N2 Nodal Clearance [ Time Frame: 3 Months ]
    N2 disease is defined as involvement of the ipsilateral mediastinal and/or subcarinal lymph nodes; if disease is cleared form these locations, then there is N2 nodal clearance



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age; no upper age limit
  • Diagnosis of NSCLC, histologically or cytologically confirmed
  • Pathologic mediastinal staging to include endobronchial ultrasound with or without endoscopic ultrasound (EBUS =/- EUS) including evaluation of N3 nodes
  • Systemic staging including CT that covers the chest, liver and adrenal glands or a PET/CT; MRI of the brain is required and must be negative for metastatic spread. If a patient is unable to tolerate MRI or has a contraindication to MRI, a head CT scan with and without contrast is acceptable
  • International Association for the Study of Lung Cancer (IASLC) version 7, subset of stage IIIA single station (N2) disease; specifically T1a-T3, N2(+) with no invasion of key structures (e.g., chest wall or diaphragm)
  • Surgically resectable disease, and patient deemed an appropriate surgical candidate by a thoracic surgeon prior to enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate organ and bone marrow function as defined by:

Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Hemoglobin ≥ 10g/dL (it is acceptable to reach this through transfusion); Platelets > 100,000 cells/mm3; Creatinine clearance ≥ 60 mg/dL (Cockcroft-Gault equation); Total bilirubin ≤ 1.5 mg/dL; Alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN; Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN;

  • Women of childbearing potential and sexually active men must agree to use effective contraception prior to study entry, for the duration of study participation and for three months after completing treatment. Adequate contraception is defined as any medically recommended method (or combination of methods) per standard of care
  • Negative serum or urine Human Chorionic Gonadotropin(b-hCG) pregnancy test within 14 days of D1 of neoadjuvant chemotherapy for women of childbearing potential
  • Informed consent obtained and signed

Exclusion Criteria:

  • Forced expiratory volume (FEV) ≤ 1.2 L/s
  • T3 tumor defined by invasion of key structures (only T3 defined by size > 7cm allowed)
  • Any lymph code > 3 cm or multistation N2 lymphadenopathy
  • Patient better served by concurrent chemoradiotherapy: The protocol recognizes that institutional standards regarding which patients are best served by operative and nonoperative approaches vary. Therefore, consistent with the American College of Chest Physicians (ACCP) guidelines, the protocol recommends multidisciplinary discussion of each patient and enrollment only of patients felt best serviced by the approach described herein
  • ≥ Grade 2 pre-existing peripheral neuropathy (per CTCAEv4)
  • Prior history of hypersensitivity to taxane or platinum therapy. If either agent was previously administered, the patient must have tolerated it well and have recovered from any adverse events
  • Recurrent disease or second primary lung cancer (only de novo IIIA disease allowed)
  • Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusion.
  • Prior treatment of any kind for this malignancy
  • Have received treatment with any drug that has not received regulatory approval for that indication within the 30 days prior to study entry
  • Any serious, uncontrolled medical disorder that would impair the ability of the subject to receive protocol driven therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276560


Locations
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United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Emory - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Kansas
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
United States, Louisiana
Ochsner Cancer Institute
New Orleans, Louisiana, United States, 70121
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Rex Cancer Center and Rex of Wakefield
Raleigh, North Carolina, United States, 27607
United States, Ohio
Case Western Reserve University - Seidman Cancer Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Jared Weiss, MD University of North Carolina, Chapel Hill
Additional Information:
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02276560    
Other Study ID Numbers: LCCC 1407
First Posted: October 28, 2014    Key Record Dates
Results First Posted: May 11, 2017
Last Update Posted: May 11, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
main tumor ranging from less than 3cm (T1 up to 7cm (T3)
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists