Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy

Launched by ASOCIACIÓN PARA EL FOMENTO DE LA INVESTIGACIÓN Y EL DESARROLLO INTEGRAL DE LA ONCOLOGÍA · Feb 25, 2013

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female \> 18 years
• • Histologically confirmed solid tumor.
• • Subjects who have not received chemotherapy and / or radiotherapy in the last 3 months.
• • Subject to initiate a chemotherapy (ie, cycle 1, day 1)
• • The chemotherapy regimen should have an inherent risk of febrile neutropenia of 10-20%.
• • Planning a minimum of 3 cycles chemotherapy.
• • Adequate bone marrow reserve defined by: leukocytes ≥ 3,000 / mm3, platelets ≥ 100.000/mm3; neutrophils ≥ 1,500 / mm3.
• • Adequate hepatic and renal function, defined by: bilirubin \<1.5 times the normal value, ALT and AST \<3 times the normal range (both can be elevated up to 5 times the normal value in patients with known liver metastases); creatinine \<1.5 times upper normal value
• • ECOG ≤ 2.
• • Informed consent
• Exclusion Criteria:
• • Patients under treatment with an investigational treatment.
• • Active infection in the last 72 h before starting chemotherapy.
• • Indication of chemotherapy dose intensity or chemotherapy included in the risk rating of febrile neutropenia \<10% or \>20%.
• • Patients with concomitant chemoradiotherapy.
• • Patients being treated with biological drugs in monotherapy.
• • Any other condition causing neutropenia.
• • History of bone marrow transplant or stem cells.