--- a
+++ b/clusters/9knumclustersv2/clust_1389.txt
@@ -0,0 +1,10 @@
+Biologic response modifiers (eg, granulocyte colony-stimulating factor) within  weeks before study entry. Chronic erythropoietin therapy is permitted provided that no dose adjustments were made within  months before first dose of study treatment
+Patients may not have received chemotherapy, targeted therapies, biologic response modifiers and/or hormonal therapy within the last  days
+Prior systemic treatments for metastatic disease are permitted but may not be ongoing, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy
+May not have received cytotoxic chemotherapy, targeted therapies, biologic response modifiers, chemotherapy, and hormonal therapy within the last  weeks, or nitrosureas within the last  weeks prior to study treatment.
+Use of biologic response modifiers, such as granulocyte colony-stimulating factor (G-CSF), will not be permitted within  weeks prior to study entry; G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity, such as febrile neutropenia, when clinically indicated or at the discretion of the investigator; however, they may not be administered to prevent a dose reduction; patients taking chronic erythropoietin are permitted, provided no dose adjustment is undertaken within  month prior to randomization or during the study
+Use of biologic response modifiers within  days of first dosing
+A history of prior radiotherapy, chemotherapy, including infusion or perfusion therapy for current disease or any immunotherapy including tumor vaccines, interferon-alfa, interleukins, levamisole or other biologic response modifiers within the past  weeks
+Treatment with radiotherapy-response or biological-response modifiers
+Have used biologic response modifiers, such as granulocyte-colony stimulating factor, within  weeks prior to signing the ICF.
+A history of prior radiotherapy, chemotherapy, including infusion or perfusion therapy for current disease or any immunotherapy including tumor vaccines, interferon-alfa, interleukins, levamisole or other biologic response modifiers within the past  weeks