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.
- Conditions
- Solid tumors
- Registration Number
- NL-OMON26479
- Lead Sponsor
- ot applicable.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hb levels before the start of and during chemotherapy; safety of the pCATS anemia treatment regimen.<br>
- Secondary Outcome Measures
Name Time Method Global QoL determined by a measurement on a linear visual analog scale assessment (LASA), length of treatment duration and time to treatment failure.<br>