A Study of Pemetrexed and Cisplatin, in Non Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Cisplatin; Thoracic Radiotherapy
Intervention description: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of a 21 day cycle for 2 cycles: with possibility of 2 additional cycles.; 75 mg/m² intravenous infusion on Day 1 of a 21 day cycle for 2 cycles; with the possibility of 2 additional cycles.; Administered at 2 gray (Gy)/fraction after completion of the pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and will continue daily (5 days per week) until the total delivered dose reaches a therapeutic goal of 66 Gy, over approximately 7 weeks.
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial investigates pemetrexed and cisplatin followed by pemetrexed and cisplatin in
      combination with radiotherapy in participants with locally advanced, non-small cell lung
      cancer (NSCLC). The purpose of the study is to assess the antitumor activity as measured by
      progression free survival 1 year after start of treatment with study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis of unresectable nonsquamous Stage IIIA or Stage IIIB
             (without malignant pleural/pericardial effusions) NSCLC.

          -  Have an ECOG performance status of 0 or 1.

          -  Previous radiation therapy should have been limited and must not have included
             thoracic radiation, whole pelvis radiation, or radiation to >25% of the participant's
             bone marrow, participants must have recovered from the toxic effects of radiation
             treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be
             completed 30 days before study entry.

          -  Have at least 1 unidimensionally measurable lesion meeting RECIST guidelines, version
             1.0.

          -  Estimated life expectancy of at least 12 weeks.

          -  Participant compliance and geographic proximity that allow adequate follow-up.

          -  Adequate bone marrow reserve, hepatic-, renal- and pulmonary function.

          -  Participants must sign an Informed Consent Document.

          -  Participants must have a total lung V20 less than or equal to 35%.

          -  For women: Must be surgically sterile, postmenopausal, or compliant with a medically
             approved contraceptive regimen, during and for 6 months after the treatment period;
             must have a negative serum pregnancy test within 7 days before study enrollment and
             must not be breast-feeding. For men: Must be surgically sterile or compliant with a
             contraceptive regimen during and for 6 months after the treatment period.

          -  Have not received prior systemic anticancer therapy for NSCLC.

        Exclusion Criteria:

          -  Have received treatment within the last 30 days of enrollment with a drug that has not
             received regulatory approval for any indication at the time of study entry.

          -  Have previously completed or withdrawn from this study or any other study
             investigating pemetrexed.

          -  Have a serious concomitant systemic disorder that, in the opinion of the investigator,
             would compromise the participant's ability to adhere to the protocol.

          -  Have a serious cardiac condition, such as myocardial infarction within 6 months,
             angina, or heart disease, as defined by the New York Heart Association Class III or
             IV.

          -  Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or
             non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively
             treated at least 5 years previously with no subsequent evidence of recurrence.
             Participants with a history of low-grade (Gleason score less than or equal to 6)
             localized prostate cancer will be eligible even if diagnosed less than 5 years
             previously.

          -  Are receiving concurrent administration of any other antitumor therapy.

          -  Have had weight loss of more than 10% over the previous 3 months before study entry.

          -  Are unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs
             (NSAIDs), other than an aspirin dose less than or equal to 1.3 grams per day, for at
             least 2 days before (5 days for long-acting agents), the day of, and for at least 2
             days after administration of pemetrexed.

          -  Are unable or unwilling to take folic acid or vitamin B12 supplementation.

          -  Are unable or unwilling to take corticosteroids.

          -  Have received a recent yellow fever vaccination (within 30 days of enrollment) or are
             receiving concurrent yellow fever vaccination.

          -  Have known hypersensitivity to pemetrexed, cisplatin, or any of the excipients in
             these medicinal products.

          -  Have evidence of clinical hearing loss.

          -  Have clinically significant third-space fluid collections, that cannot be controlled
             by drainage or other procedures prior to study entry.