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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.


- candidate number1703
- NTR NumberNTR409
- ISRCTNISRCTN81146641
- Date ISRCTN created27-feb-2007
- date ISRCTN requested18-nov-2005
- Date Registered NTR19-sep-2005
- Secondary IDsN/A 
- Public TitleA 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.
- Scientific TitleA 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.
- ACRONYMpCATS
- hypothesisAn 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.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Colorectal cancer, Ovarian cancer
- Inclusion criteria1. 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.
- Exclusion criteriaExcluded 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 15-sep-2005
- planned closingdate1-mei-2008
- Target number of participants23
- InterventionsAnemia-treatment consisting of preventive RBCT before the start of chemotherapy followed by the maintenance administration of Epo-alpha s.c. during chemotherapy.
- Primary outcomeHb levels before the start of and during chemotherapy; safety of the pCATS anemia treatment regimen.
- Secondary outcomeGlobal QoL determined by a measurement on a linear visual analog scale assessment (LASA), length of treatment duration and time to treatment failure.
- Timepoints
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. A.C. Ogilvie
- CONTACT for SCIENTIFIC QUERIESProf. MD. J.W.R. Nortier
- Sponsor/Initiator ít Lange Land Hospital, Department of Internal Medicine, Leiden University Medical Center (LUMC), Department of Clinical Oncology
- Funding
(Source(s) of Monetary or Material Support)
Comprehensive Cancer Centre (Integraal Kankercentrum), Janssen Cilag BV, Ortho Biotech
- PublicationsN/A
- Brief summarySupportive 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
- Main changes (audit trail)
- RECORD19-sep-2005 - 30-sep-2009


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