Cisplatin and Nab-paclitaxel for (N2) Defined NSCLC

NCT02276560 | Terminated Phase 2 Results DMC

• 1 other identifier: LCCC 1407
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 9

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.

Conditions

Stage IIIA Non-Small Cell Lung Cancer

Keywords

main tumor ranging from less than 3cm (T1 up to 7cm (T3)

Outcome Measures

Primary Outcomes (1)

• Rate of N2 Nodal Clearance

  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

  3 Months

Study Arms (3)

Neoadjuvant Cisplatin,nab-paclitaxel

EXPERIMENTAL

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

Adjuvant Cisplatin,nab-paclitaxel

EXPERIMENTAL

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+pemetrexed or gemcitabine

OTHER

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

Interventions

Neoadjuvant Cisplatin, nab-paclitaxel DRUG

Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery

Also known as: Platinol, Abraxane

Neoadjuvant Cisplatin,nab-paclitaxel

Adjuvant Cisplatin,nab-paclitaxel DRUG

Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2

Also known as: Platinol, Abraxane

Adjuvant Cisplatin,nab-paclitaxel

Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine DRUG

Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4

Also known as: Platinol, Alimta, Gemzar

Cisplatin+pemetrexed or gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (9)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory - Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

Ochsner Cancer Institute

New Orleans, Louisiana, 70121, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Rex Cancer Center and Rex of Wakefield

Raleigh, North Carolina, 27607, United States

Location

Case Western Reserve University - Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Related Links

• Clinical Trials - University of North Carolina - Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

130-nm albumin-bound paclitaxel; Cisplatin; Albumin-Bound Paclitaxel; Pemetrexed; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Robin V. Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

Robin_V_Johnson@med.unc.edu

919-966-1125

Study Officials

• Jared Weiss, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 28, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 11, 2017
• Results First Posted: May 11, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)