An upfront RBCT aiming at low-normal Hb levels will ameliorate anemia-caused tumor hypoxia-related resistance to chemotherapy before the start of chemotherapy and may decrease secondary anemia-induced endogenous release of cytokines like VEGF,…
ID
Bron
Verkorte titel
Aandoening
Solid tumors
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Hb levels before the start of and during chemotherapy; safety of the pCATS anemia treatment regimen.
Achtergrond van het onderzoek
Supportive care treatment of anemia with a blood transfusion before the start of standard chemotherapy, maintained with weekly erythropoetin-alpha subcutaneously injections during the duration of the chemotherapy
Doel van het onderzoek
An upfront RBCT aiming at low-normal Hb levels will ameliorate anemia-caused tumor hypoxia-related resistance to chemotherapy before the start of chemotherapy and may decrease secondary anemia-induced endogenous release of cytokines like VEGF, osteopontin. The maintenance of optimal Hb levels at this lower-normal range during chemotherapy by weekly maintenance administration of Epo-alpha s.c. at doses with proven safety and efficacy creates optimal conditions for tumor oxygenation, without the presumably high-Hb level associated adverse effects.
Onderzoeksproduct en/of interventie
Anemia-treatment consisting of preventive RBCT before the start of chemotherapy followed by the maintenance administration of Epo-alpha s.c. during chemotherapy.
Publiek
P.O. Box 3015
A.C. Ogilvie
Zoetermeer 2700 KJ
The Netherlands
+31 (0)79 3462881
ogilvia1@llz.nl
Wetenschappelijk
P.O. Box 3015
A.C. Ogilvie
Zoetermeer 2700 KJ
The Netherlands
+31 (0)79 3462881
ogilvia1@llz.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL369 |
NTR-old | NTR409 |
Ander register | : N/A |
ISRCTN | ISRCTN81146641 |