A phase II study of up-front red blood cell transfusion followed by maintenance Erythropoetin-alpha (Epo-alpha) s.c. support during chemotherapy of solid tumors.

ot applicable.0 个研究点目标入组 23 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•1. Histological or cytological documentation of solid tumor (breast- or colorectal- or ovarian- or lung- or esophageal- or stomach- or bladder- or prostate- or germ cell- or cervical cancer or sarcoma)
•2. Age >= 18 years;
•3. ECOG performance status of 0, 1 or 2;
•4. Being scheduled to receive chemotherapy or having received already 1 cycle of chemotherapy and being scheduled to receive at least 3 cycle of chemotherapy prior to study entry;
•5. Life expectancy of at least 6 month;
•6. Signed written informed consent obtained prior to study entry;
•7. Anemia: Hb <7.0 mmol/L tested within 7 days before enrolment;
•8. Adequate bone marrow function as assessed within 7 days before enrolment by:
•a. Absolute neutrophil count >=1.5x10 9/L;
•b. Platelets >= 100x10 9/L;
•9. Iron status measurements including levels of ferritin, transferrin, iron and iron saturation within 7 days after enrolment;
•10. Patient is able to comply with scheduled follow up.

•Excluded medical conditions:
•1. Having more than 1 cycle of the current chemotherapy administered prior to inclusion;
•2. Having 1 cycle of chemotherapy administered before inclusion and scheduled to receive less than 3 additional cycles;
•3. Untreated folate or cobalamin deficiency;
•4. Untreated haemolytic anemia defined by decreased serum haptoglobulin levels;
•5. Anemia due to hypoproliferative or maturation bone marrow disorders;
•6. Clinically evident untreated congestive heart failure;
•7. Serious, untreated cardiac arrhythmias;
•8. Symptoms of untreated coronary heart disease or ischemia;
•9. Untreated hypertension;
•10. History of HIV infection.
•Excluded therapies, medications and conditions, previous and concomitant:
•11. Androgen treatment within 2 month before enrolment;
•12. Anti-cancer chemotherapy or immunotherapy within 4 weeks of study entry;
•13. Darbepoetin or erythropoetin treatment within 4 weeks before enrolment;
•14. Bone marrow transplantation or stem cell transplantation within 4 months of study entry;
•15. Investigational drug therapy within 4 weeks of study entry or during this study,
•16. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Adequate birth control measures will be required during the course of the trial,
•17. Known or suspected allergy to Epo-alpha.

发起方

ot applicable.