Solid tumors
Conditions
Sponsors
Not applicable.
Eligibility
Inclusion criteria
Inclusion criteria: 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 =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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hb levels before the start of and during chemotherapy; safety of the pCATS anemia treatment regimen. | — |
Secondary
| Measure | Time frame |
|---|---|
| Global QoL determined by a measurement on a linear visual analog scale assessment (LASA), length of treatment duration and time to treatment failure. | — |
Contacts
Public ContactA.C. Ogilvie
’t Lange Land Ziekenhuis, Department of Internal Medicine, P.O. Box 3015
Outcome results
None listed