Pemetrexed &Oxaliplatin in Patients w Recurrent NSCLCa After Failure to Platinum Based Adjuvant Chem
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Oxaliplatin; Pemetrexed
Intervention description: Dose Regimen: 120 mg/m^2 on Days 1 every 21 days; Dose Regimen: 500 mg/m^2 on Days 1 every 21 days
Intervention MeSH terms: Oxaliplatin; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent; non-small cell

Summary:

      The purpose of this study is:

        -  To find out if the chemotherapy treatment using Pemetrexed (Alimta) and Oxaliplatin
           (Eloxatin) given together will kill the cancer cells in the patient's body and shrink
           the size of their tumor. This may allow patients to live longer or decrease the
           frequency and/or severity of the symptoms caused by the cancer. Pemetrexed has been
           approved by the Food and Drug Administration (FDA) to treat Lung Cancer. Oxaliplatin has
           been approved by the FDA for the treatment of Colon Cancer. The combination of these two
           drugs has been used to treat patients with Non-Small Cell Lung Cancer in Italy but not
           yet in the USA

      Other purposes of this study are:

        -  To better detail the toxic effects of this chemotherapy combination.

        -  To determine whether the level of specific gene and/or gene products (genes are genetic
           material that allows cells to make proteins such as enzymes) are useful to predict if
           this chemotherapy combination will work or not.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of completely resected NSCLC and adjuvant/neoadjuvant chemotherapy with
             platinum-based regimen

          -  Histologically/cytologically confirmed recurrence of NSCLC after curative therapy with
             surgery and adjuvant/neoadjuvant chemotherapy

          -  Must have measurable disease according to RECIST criteria

          -  ECOG Performance Score of 0-2 determined within 2 weeks prior to enrollment

          -  Expected survival > 12 weeks

          -  Adequate bone marrow function,as evidenced by:

               1. Absolute neutrophil count (ANC) > 1,500/µL

               2. Platelet count > 100,000/µL

               3. Hemoglobin > 8 g/dL (determined within 2 weeks prior to enrollment)

          -  Adequate renal function evidenced by:

               1. serum creatinine < 1.5 mg/dL OR

               2. calculated creatinine clearance >45 mL/min.

          -  Adequate hepatic function evidenced by:

               1. Serum total bilirubin < 1.5 mg/dL OR less than the upper limit of normal (ULN)

               2. Alkaline phosphatase < 3X the ULN for the reference lab (< 5X the ULN for
                  patients with known hepatic or bony metastases)

               3. SGOT/SGPT < 3X the ULN for the reference lab (< 5X the ULN for patients with
                  known hepatic metastases)

          -  Must be recovered from both acute and late effects of any prior surgery, radiotherapy,
             other antineoplastic therapy

          -  Signed informed written consent

          -  Patients of childbearing potential and their partners must agree to use an effective
             form of contraception during the study and for 90 days following last dose of study
             medication

        Exclusion Criteria:

          -  Patients amenable to a "curative intent" therapeutic approach (re-resection with or
             without preoperative or postoperative therapy or chemoradiotherapy without surgery are
             not eligible for this study).

          -  An active infection or with fever > 101.00 F within 3 days of first scheduled day of
             protocol treatment

          -  Active CNS metastases. Patients with stable CNS disease, who have undergone
             radiotherapy (or surgery ± radiotherapy) at least 4 weeks prior to planned first
             protocol treatment and who have been on stable or decreasing dose of corticosteroids
             for >2 weeks are eligible

          -  Prior malignancy within the past 5 years except for curatively treated basal cell
             carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate
             cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3
             months apart, with most recent evaluation no more than 4 weeks prior to entry.

          -  Any diagnosis of NSCLC occurring after 5 years of curative therapy (surgery plus
             adjuvant chemotherapy) for original NSCLC will be considered a second primary rather
             than a recurrence and will render patient ineligible for this study. An exception will
             be if both tumors are considered the same after a direct pathologic comparison if
             both, sponsor and investigator agree.

          -  Patients that at discretion of the PI have a second primary rather than metastasis are
             not eligible

          -  Known hypersensitivity to any of the components of oxaliplatin or pemetrexed.

          -  Patients receiving concurrent investigational therapy or who have received
             investigational therapy within 30 days of the first scheduled day of protocol
             treatment

          -  Patients who received radiotherapy to more than 33% of their bone marrow or received
             any radiotherapy within 4 weeks of entry

          -  Peripheral neuropathy ≥ Grade 2

          -  Patients pregnant or lactating

          -  Any other medical condition, including mental illness or substance abuse, deemed
             likely to interfere with patient's ability to sign informed consent, cooperate and
             participate in the study, or interfere with interpretation of the results.

          -  History of allogeneic transplant

          -  Known history of HIV or Hepatitis B or C infection. Patients with Hepatitis B carrier
             status only are eligible.