Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor (Monitor-GCSF)
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Purpose
This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for febrile neutropenia (FN) who are receiving filgrastim biosimilar for primary or secondary FN prophylaxis to better describe the patient population at risk for FN, to describe prophylaxis patterns involving filgrastim biosimilar, and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy and surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which therapy and prophylaxis of FN is in congruence with guideline recommendations.
| Condition |
|---|
|
Febrile Neutropenia Cancer Breast Cancer Ovarian Cancer Lung Cancer Prostate Cancer Multiple Myeloma Bladder Cancer B-cell Lymphoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Chemotherapy-treated Cancer Patients at Risk for Febrile Neutropenia and Treated Prophylactically With Filgrastim Biosimilar. |
- Absolute neutrophil count (ANC) [ Time Frame: 6 months, 6 cycles of chemotharapy ] [ Designated as safety issue: No ]Describe intraindividual changes in ANC.
- Cohort identification and differentiation [ Time Frame: 6 months, 6 cycles of chemotherapy ] [ Designated as safety issue: No ]Patient profiles based on medical history, concomitant comorbid conditions and current clinical status.
- Nonresponder analyses [ Time Frame: 6 months, 6 cycles of chemotherapy ] [ Designated as safety issue: Yes ]
Patient- and center-level variables between patients who had:
- chemotherapy dose delays or reductions,
- surgery delays or cancellations, and
- radiotherapy delays, dose reductions or cancellations vs no such events and
- patients who died vs. survived during the course of prophylaxis with filgrastim biosimilar in all patients and those with break-through FN episodes.
| Estimated Enrollment: | 1500 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Only 1 group
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for febrile neutropenia.
Inclusion Criteria:
- Male or female adults (age > / = 18 years)
- Diagnosed with one of the following types and stages of tumors: stage III or IV breast cancer; stage III or IV ovarian cancer; stage III or IV bladder cancer; stage III or IV lung cancer; metastatic prostate cancer; stage III or IV diffuse large B-cell lymphoma; multiple myeloma.
- Planned to receive primary prophylaxis with ZARZIO® at the first cycle of chemotherapy (regardless of line of chemotherapy); or receiving secondary prophylaxis with ZARZIO® irrespective of chemotherapy cycle.
- Treated with commercially available ZARZIO® per physician's best clinical judgment and per current European ZARZIO® label.
- Female patients must be either post-menopausal for one year or surgically sterile or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Oral contraceptive use is allowed.
- Informed written consent to participate in the study by patients or their legal guardian.
Exclusion Criteria:
- Patients with myeloid malignancies, with the exception of multiple myeloma.
- Sensitivity to ZARZIO® or any other CSF.
- Hypersensitivity to E. coli-derived proteins.
- Radiotherapy to ≥ 20% of total body bone.
- Infection within two weeks of starting current line of chemotherapy.
- Patients with several medical condition(s) that in view of the investigator prohibits participation in the study.
- Patients with willfully negligent nonadherence to their cancer treatment.
- Use of any investigational agent in the 30 days prior to enrollment.
- Women of childbearing potential not using the contraception method(s) described above.
- Women who are breastfeeding.
Contacts and Locations| Contact: Matthew Turner | +49 8024 476 ext 2272 | matthew.turner@sandoz.com |
| Contact: Michael Muenzberg, MD | +49 8024 476 ext 2253 | michael.muenzberg@sandoz.com |
| Czech Republic | |
| Nemocnice Znojmo | Recruiting |
| Znojmo, Czech Republic, 66902 | |
| Contact: Karol Krizan, Dr. +420515215123 krizankarol@gmail.com | |
| Principal Investigator: Karol Krizan, Dr. | |
| France | |
| Hôpital Européen Georges Pompidou - Service Oncologie Médicale | Recruiting |
| Paris, France, 75908 | |
| Contact: Florian Scotte, Dr. +33156093473 florian.scotte@yahoo.fr | |
| Principal Investigator: Florian Scotte, Dr | |
| Germany | |
| Universitaetsklinik Hamburg-Eppendorf, Med. Klinik II Onkologie, Haematologie | Recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Carsten Bokemeyer, Prof. +4940741052960 c.bokemeyer@ukl.uni-hamburg.de | |
| Principal Investigator: Carsten Bokemeyer, Prof. Dr. | |
| Italy | |
| Azienda Ospedaliero Universitaria "San Giovanni Battista di Torino" | Recruiting |
| Torino, Italy, 10126 | |
| Contact: Mario Boccadoro, Prof. +390116336107 mario.boccadoro@unito.it | |
| Principal Investigator: Mario Boccadoro, Prof. Dr. | |
| Poland | |
| SPSK1 Klinika Hematologii | Recruiting |
| Lublin, Poland, 20-081 | |
| Contact: Anna Dmoszynska, Prof. +48815345468 annadmosz@wp.pl | |
| Principal Investigator: Anna Dmoszynska, Prof. Dr. | |
| Romania | |
| Centrul de Diagnostic si Tratament Euromedic Fundeni | Recruiting |
| Bucuresti, Romania, 022328 | |
| Contact: Dana Stanculeanu, Dr. +40744327992 dlstanculeanu@gmail.com | |
| Principal Investigator: Dana Stanculeanu, Dr. | |
| Spain | |
| Hospital Clinic i Provincial de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Pere Gascón Vilaplana +34932275400 gascon@clinic.ub.es | |
| Principal Investigator: Pere Gascón Vilaplana | |
| Switzerland | |
| IMO Clinique de Genolier | Recruiting |
| Genolier, Switzerland, 1272 | |
| Contact: Matti Aapro, Dr. +41223669134 cromon@genolier.net | |
| Principal Investigator: Matti Aapro, Dr. | |
| United Kingdom | |
| The Rotherham NHS Foundation Trust - Dept. of Haematology | Recruiting |
| Rotherham, United Kingdom, S60 2UD | |
| Contact: Helen Barker, Dr. +441709304720 helen.barker@rothgen.nhs.uk | |
| Principal Investigator: Helen Barker, Dr. | |
| Study Director: | Matthew Turner, PhD | Sandoz |
More Information
No publications provided
| Responsible Party: | Sandoz |
| ClinicalTrials.gov Identifier: | NCT01459653 History of Changes |
| Other Study ID Numbers: | Monitor-GCSF, EP-502 |
| Study First Received: | August 30, 2011 |
| Last Updated: | October 24, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé Spain: Agencia Española de Medicamentos y Productos Sanitarios Romania: National Medicines Agency Czech Republic: State Institute for Drug Control |
Keywords provided by Sandoz:
|
Febrile neutropenia cancer chemotherapy, primary prophylaxis secondary prophylaxis |
filgrastim granulocyte colony stimulating factor observational study noninterventional study |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Breast Neoplasms Fever Lung Neoplasms Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Neutropenia Ovarian Neoplasms Prostatic Neoplasms Lymphoma, B-Cell Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms |
Urinary Bladder Diseases Urologic Diseases Breast Diseases Skin Diseases Body Temperature Changes Signs and Symptoms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013