TerminatedPhase 2NCT02276560

Cisplatin and Nab-paclitaxel for (N2) Defined NSCLC

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.

Checked against the public recordLast updated May 11, 2017 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations9
SponsorUNC Lineberger Comprehensive Cancer Center
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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
UNC Lineberger Comprehensive Cancer Center
Interventions being studied
Drug: Neoadjuvant Cisplatin, nab-paclitaxel; Drug: Adjuvant Cisplatin,nab-paclitaxel; Drug: Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • Moffitt Cancer CenterTampa, Florida
  • Emory - Winship Cancer InstituteAtlanta, Georgia
  • University of Kansas Cancer CenterKansas City, Kansas
  • Ochsner Cancer InstituteNew Orleans, Louisiana
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina
  • Rex Cancer Center and Rex of WakefieldRaleigh, North Carolina
  • Case Western Reserve University - Seidman Cancer CenterCleveland, Ohio
  • University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
  • Swedish Cancer InstituteSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 11, 2017. Always confirm current availability with the study team.

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