
Hinsdale
Hematology Oncology Seeks Participants for a Phase III Randomized Trial of
Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely
Resected Stage IB (≥ 4cm)- IIIA Non-Small Cell Lung Cancer (NSCLC)
Why is this study being done?
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This study
E1505 (medical research) is being done because in some people with NSCLC,
the cancer returns after surgery- even after chemotherapy has been given.
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The purpose
is to find out whether adding a new drug (bevacizumab) to the standard
chemotherapy is better at stopping the cancer’s return. Bevacizumab is a
drug that stops new blood vessels from forming in tumors, thus choking off
the blood supply. It is approved for use in advanced lung, colon, and breast
cancer.
What does this study involve?
After surgical removal of your tumor, you will be randomized (assigned to
a treatment group by chance) into one of the study arms:
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Arm A:
1 of 4 cisplatin-based chemotherapy regimens (no bevacizumab) for 4 cycles
of treatment, each lasting 3 weeks = 12 weeks of therapy
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Arm B:
1 of 4 cisplatin-based chemotherapy regimens for 4 cycles of treatment, each
lasting 3 weeks = 12 weeks of therapy PLUS bevacizumab 15mg/kg IV
every 3 weeks for 1 year
Patients’ disease-free status, survival time are monitored
Who will take part in the study?
About 1500 people in North America and Europe will take part in this study. The
requirements for participating are as follows (these are the main requirements
only. Your physician will perform a more detailed review of your eligibility if
you are interested in participating):
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Age at least 18 years with stage IB (at least 4 cm) through IIIA NSCLC
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Surgery between 42 and 84 days before being assigned to a treatment group
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No prior chemotherapy
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No hormonal cancer or radiation therapy within past 5 years
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No history of cancer within past 5 years
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No heart risk, such as no heart attacks or chest pain (angina) in the past
year; any history of stroke
http://www.cancer.gov/clinicaltrials/ECOG-E1505
http://clinicaltrials.gov/ct/show/NCT00324805
http://www.ecog.org
For further
information or to express interest in this important research study, please call
Jan Wilson at 630-654-1790.