Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: pemetrexed; cisplatin; Carboplatin; Gemcitabine Hydrochloride; Vinorelbine Tartrate; Docetaxel
Intervention MeSH terms: Carboplatin; Gemcitabine; Docetaxel; Pemetrexed; Vinorelbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carboplatin; Cisplatin; Pemetrexed (Altima); Taxotere (Docetaxel); Vinorelbine Tartrate (Navelbine); Stage IB-III; non squamous; non-small cell lung cancer; 11-106

Summary:

      The purpose of this study is to test a new approach to the use of standard drugs before
      surgery in patients with lung cancer. This study will find out what effects, good and/or bad,
      that this approach has on the cancer.

      It is routine to give chemotherapy prior to surgery in patients with this type of lung
      cancer, to help keep it from coming back. It is also routine to perform a special type of
      scan called a PET scan. This PET scan measures how active a cancer is by use of a special
      tracer made out of sugar. In this study, all patients will have a PET scan and then be
      treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a
      "non-squamous" cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In
      rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most
      patients, a repeat PET scan will show that the tumor is decreasing and they will complete
      standard chemotherapy then go on to have surgery.

      In some patients, a repeat PET scan will show that the tumor has not decreased enough. For
      these patients, the routine practice is to proceed with surgery. This research study will
      test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine
      and cisplatin to a different treatment called vinorelbine and docetaxel is safe and
      effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a
      different way than pemetrexed or gemcitabine and cisplatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic confirmation of NSCLC at MSKCC

          -  Stages IB, IIA, IIB, IIIA or IIIB NSCLC

          -  Primary tumor must measure ≥ 2 cm on CT imaging (per PERCIST guidelines)

          -  Primary tumor must be FDG-avid with an SUVmax >4.5 (to be consistent with PERCIST
             guidelines)

          -  Patients must be candidates for resection with curative intent

          -  Age ≥ 18 years

          -  Karnofsky performance status ≥ 70%

          -  Normal bone marrow function

          -  leukocytes ≥ 3,000/μl

          -  absolute neutrophil count ≥ 1,500/μl

          -  platelets ≥100,000/μl

          -  hemoglobin ≥9gm/dl.

          -  Adequate hepatic function

          -  Total bilirubin ≤1.5 x ULN

          -  AST ≤ 1.5 x UNL, ALT ≤ 1.5 x ULN

          -  Alkaline phosphatase ≤ 1.5x ULN

          -  Women of childbearing age must have a negative pregnancy test

          -  Men and women of childbearing potential must be willing to use effective contraception
             while on treatment and for at least 3 months thereafter

          -  Patients must have the ability to understand and the willingness to sign a written
             informed consent document

        Exclusion Criteria:

          -  Patients must not be receiving any other investigational agents

          -  History of myocardial infarction or unstable angina within the past 12 months Patients
             with peripheral neuropathy > grade 1

          -  Other serious illness or medical condition including unstable cardiac disease
             requiring treatment, history of significant neurologic or psychiatric disorders
             (including psychotic disorders, dementia, or seizures), or active uncontrolled
             infection.

          -  Patients with diabetes mellitus requiring insulin therapy (per PERCIST guidelines)

          -  Patients with third space fluid which cannot be adequately controlled with drainage

          -  Women who are pregnant or breast-feeding

          -  Psychiatric illness or social situation that would limit compliance with study
             requirements

          -  Patients with known HIV infection requiring antiretroviral medications and those with
             AIDS

          -  Baseline subjective hearing deficit, even if it does not require a hearing aid or
             intervention, or interfere with activities of daily living (CTCAE grade 2 or higher)

          -  Baseline renal function <60 ml/min as calculated by the equation of Cockcroft and
             Gault using the patient's age, weight (kg), and serum creatinine (mg/dl).

          -  Congestive heart failure with New York Heart Association functional classification >
             II, characterized by fatigue, dyspnea or other symptoms which limit activities of
             daily life.

        Selection of Pemetrexed versus Gemcitabine: Patients treated with pemetrexed must meet all
        of the following criteria:

          -  Non-squamous histology

          -  Patients must have the ability to interrupt non-steroidal anti-inflammatory drugs
             (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days
             following administration of pemetrexed

          -  Patients must have the ability to take folic acid, Vitamin B12, and dexamethasone
             according to protocol

          -  Patient refuses to take cisplatin