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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.


N/A
18 Years
N/A
Open (Enrolling)
Both
Febrile Neutropenia, Cancer, Breast Cancer, Ovarian Cancer, Lung Cancer, Prostate Cancer, Multiple Myeloma, Bladder Cancer, B-cell Lymphoma

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Trial Information

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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Absolute neutrophil count (ANC)

Outcome Description:

Describe intraindividual changes in ANC.

Outcome Time Frame:

6 months, 6 cycles of chemotharapy

Safety Issue:

No

Principal Investigator

Matthew Turner, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Sandoz

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Monitor-GCSF, EP-502

NCT ID:

NCT01459653

Start Date:

February 2010

Completion Date:

August 2012

Related Keywords:

  • Febrile Neutropenia
  • Cancer
  • Breast Cancer
  • Ovarian Cancer
  • Lung Cancer
  • Prostate Cancer
  • Multiple Myeloma
  • Bladder Cancer
  • B-Cell Lymphoma
  • Febrile neutropenia
  • cancer
  • chemotherapy,
  • primary prophylaxis
  • secondary prophylaxis
  • filgrastim
  • granulocyte colony stimulating factor
  • observational study
  • noninterventional study
  • Urinary Bladder Neoplasms
  • Breast Neoplasms
  • Fever
  • Lung Neoplasms
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neutropenia
  • Ovarian Neoplasms
  • Prostatic Neoplasms
  • Lymphoma, B-Cell

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