Status:
TERMINATED
Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
Hoosier Cancer Research Network
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 eval...
Detailed Description
OUTLINE: This is a multi-center study. * Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles * Radiation will start between day...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00732303
Start Date
January 1 2009
End Date
December 1 2010
Last Update
April 27 2016
Active Locations (18)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
2
NorthShore University Health System - Kellogg Cancer Center
Evanston, Illinois, United States, 60201
3
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
4
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403