Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Radiation Therapy
Intervention description: Pemetrexed (Alimta) 500mg/^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles; Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Pemetrexed is approved for second line therapy in metastatic NSCLC. Given the single-agent
      activity of pemetrexed and the tolerability of pemetrexed in combination with radiation, this
      study will evaluate survival rates and toxicities in patients with poor risk stage III NSCLC.
    

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.