Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoosier Cancer Research Network
• Collaborator: Eli Lilly and Company
• Treatments: Pemetrexed

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.