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

Stopped early · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00732303

Run by

Hoosier Cancer Research Network

People needed

8

Starts

2009-01-01

Expected to finish

2010-12-01

Last updated by the study team

2016-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• NorthShore University Health System - Kellogg Cancer Center — Evanston, Illinois, United States
• Medical & Surgical Specialists, LLC — Galesburg, Illinois, United States
• Cancer Care Center of Southern Indiana — Bloomington, Indiana, United States
• Fort Wayne Oncology & Hematology, Inc — Fort Wayne, Indiana, United States
• IN Onc/Hem Associates — Indianapolis, Indiana, United States
• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
• Community Regional Cancer Center — Indianapolis, Indiana, United States
• Horizon Oncology Center — Lafayette, Indiana, United States
• Medical Consultants, P.C. — Muncie, Indiana, United States
• Monroe Medical Associates — Munster, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Providence Medical Group — Terre Haute, Indiana, United States
• Siteman Cancer Center — St Louis, Missouri, United States
• Hematology Oncology Associates S.J., P.A. — Mount Holly, New Jersey, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Pennsylvania Oncology-Hematology Associates — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center Extramural Research Program — Rockledge, Pennsylvania, United States

Full record on ClinicalTrials.gov

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