Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Alimta
Intervention description: 500 mg/m^2 by vein Once Over 10 Minutes Every 3 Weeks
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; Lung Cancer; NSCLC; Malignant pleural effusion; Pericardial effusion; Pemetrexed; Alimta; LY231514; Poor Performance Status; Asymptomatic Brain Metastases

Summary:

      The goal of this clinical research study is to learn how effective the drug pemetrexed
      (ALIMTA®) is in treating advanced NSCLC in patients with poor performance status (PS)
      (inability to perform every day activities without difficulty).

      Objectives:

      Primary Objectives:

        -  PS = 2 cohort: Response

        -  PS = 3 cohort: Descriptive

      Secondary Objectives:

        -  Tolerability of single agent pemetrexed (Alimta®) in PS = 3 NSCLC patients

        -  Improved symptoms (both cohorts)

        -  Molecular Correlative studies (both cohorts)

        -  Overall survival

        -  Time to progression
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically proven Stage IIIB (T4 lesion due to malignant pleural
             or pericardial effusion) or Stage IV. Clinically significant pleural or peritoneal
             effusions should be drained prior to dosing.

          2. Zubrod PS 2 or PS 3

          3. Patients with asymptomatic brain metastases and no requirement for corticosteroids or
             anticonvulsants are eligible for this clinical trial.

          4. Measurable OR non-measurable disease documented by CT or MRI.

          5. Patients may have had </=1 prior chemotherapy regimens but multiple prior biologic
             regimens. At least 4 weeks need to have elapsed since last chemotherapy or biologic
             therapy administration.

          6. Prior radiation therapy is permitted; however, at least two weeks must have elapsed
             since the completion of prior radiation therapy and patients must have recovered from
             all associated toxicities at the time of registration. Measurable or non-measurable
             disease must be outside the previous radiation field OR patients with visible
             progression or new lesions within the radiation field are eligible.

          7. At least two weeks must have elapsed since surgery and patients must have recovered
             from all associated toxicities at the time of registration.

          8. Creatinine clearance >/= 45 cc/min measured or calculated using the following formula:
             Calculated Creatinine Clearance = (140 - age) X WT (kg) X (0.85 if female)/72 X
             creatinine (mg/dl) Calculated Creatinine Clearance = (140 - age) X WT (kg) X (1.00 if
             male)/72 X creatinine (mg/dl)

          9. Absolute neutrophil count (ANC) >/= 1,500/µl

         10. Platelet >/= 100,000/µl

         11. ALT/AST: </=3.0 x upper limit of normal (ULN) except in known hepatic metastasis
             wherein may be </= 5 x ULN

         12. Bilirubin: </=1.5 x ULN

         13. Hemoglobin: >/=9.0 x 10^9/L

         14. Patient must not be pregnant or breastfeeding. Patients of childbearing potential
             agree to practice an effective contraceptive method for the duration of the study.

         15. Patients must be informed of the investigational nature of this study and must sign
             and give written informed consent in accordance with institutional and federal
             guidelines.

         16. Men and women, aged >/=18 years.

        Exclusion Criteria:

          1. Prior treatment with pemetrexed therapy.

          2. Patients planning to receive any other concomitant anticancer treatment including
             chemotherapy, radiation therapy, biologic agents or any other investigational drugs.

          3. Women who are pregnant or breastfeeding may not participate in this trial. All women
             of childbearing potential must have a negative pregnancy test within 24 hours prior to
             enrolling in the study.

          4. Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a
             5-day period (8-day period for long-acting agents, such as piroxicam).

          5. Inability and unwillingness to take folic acid or vitamin B12 supplementation.

          6. Inability to take corticosteroids.

          7. Prior malignancy except for the following: adequately treated basal cell or squamous
             cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer
             from which the patient is currently in complete remission or other cancer from which
             the patient has been disease-free for >/= 5 years.