Cisplatin and Nab-paclitaxel for (N2) Defined NSCLC

• Status: Terminated
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Gemcitabine; Paclitaxel; Pemetrexed

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