Clinical trial NCT00732303 (phase 2, status: terminated)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: pemetrexed
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Reason stopped: 
    study terminated due to withdrawal of pharmaceutical funding
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological proof of Non Small Cell Lung Cancer (NSCLC)

          -  Measurable or non-measurable disease per RECIST as evaluated by imaging within 28 days
             prior to registration for protocol therapy

          -  Unresectable Stage IIIA or IIIB disease as evaluated by imaging within 28 days prior
             to registration for protocol therapy

          -  Weight loss of greater than 10% in the preceding six months prior to registration for
             protocol therapy.

          -  Serum albumin < 0.85 x institutional lower limit of normal

          -  Able and willing to interrupt non-steroidal anti-inflammatory agents for 2 days before
             (5 days for long acting agents such as piroxicam), the day of, and 2 days following
             administration of pemetrexed

          -  Lung V20 < 35% within 14 days prior to registration for protocol therapy, as planned
             by the radiation oncologist

          -  Mean lung dose < 20 Gy within 14 days prior to registration for protocol therapy, as
             planned by the radiation oncologist

          -  Written informed consent and HIPAA authorization for release of personal health
             information

          -  Age ≥ 18 years

          -  Females of childbearing potential and males must be willing to use an effective method
             of contraception (hormonal or barrier method of birth control; abstinence) from the
             time of consent until at least 90 days following completion of study treatment.

          -  Females of childbearing potential must have a negative pregnancy test within 7 days
             prior to registration for protocol therapy. Patients are considered not of child
             bearing potential if they are surgically sterile (they have undergone a hysterectomy,
             bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.

        Exclusion Criteria:

          -  Patients with malignant pleural effusions are not eligible. The only exception is a
             patient with a pleural effusion visible only on CT scan (and not visible on CXR) OR
             deemed too small to tap.• No CNS metastases. All patients must undergo a CT scan/MRI
             of the brain within 28 days prior to registration for protocol therapy to exclude
             brain metastasis.

          -  No prior chemotherapy, adjuvant therapy or radiotherapy for lung cancer.

          -  No metastatic disease as determined by PET scan within 28 days prior to registration
             for protocol therapy.

          -  No active clinically serious infections as judged by the treating investigator (> CTC
             v3, Grade 2) including known human immunodeficiency virus (HIV) infection or chronic
             Hepatitis B or C.

          -  No other active malignancies.

          -  No history of collagen vascular disease (CVD).

          -  No significant history of cardiac disease. Must not have unstable angina (anginal
             symptoms at rest).

          -  No history of psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Females must not be breastfeeding.