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Study Complete
Sponsor ID
20020122

A Study of Primary Prophylaxis with Neulasta (pegfilgrastim) Versus Secondary Prophylaxis After Chemotherapy in Elderly Subjects (>/= 65 years old) with Cancer

Sponsor ID
20020122
Clinicaltrials.gov ID
NCT00277160
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to assess pegfilgrastim starting with the first cycle versus secondary prophylaxis on neutropenic events (including neutropenia +/- fever, dose delays, dose reductions, and hospitalizations) in older patients receiving chemotherapy.

Additional Study Details

Phase
Phase 4
Product
pegfilgrastim
Type
Interventional
Masking
None (Open Label)
Enrollment
852
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of febrile neutropenia, defined by ANC < 1.0 x 10^9/L and temperature ≥ 38o C on the same day

Timeframe: End of the last cycle of chemotherapy or the date of early termination from the study

Secondary Outcome Measures

Incidence of grade 3 and 4 neutropenia

Timeframe: End of the last cycle of chemotherapy or the date of early termination from the study

Dose delays or dose reductions

Timeframe: End of the last cycle of chemotherapy or the date of early termination from the study

Incidence of febrile neutropenia with a more strict definition (ANC < 0.5 x 10^9/L and temperature ≥ 38o C), on the same day

Timeframe: End of the last cycle of chemotherapy or the date of early termination from the study

Locations

No locations found.
Study Info
Age
65+ years
Condition
  • Low White Blood Cell
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  • Breast Cancer
  • Lung Cancer - General
  • Lymphoma
  • Ovarian Cancer
    • Sex
    All
    Trial Dates
    Jun 2002 - Nov 2004
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - >/= 65 years old - documented diagnosis of lung, breast, or ovarian cancer, or NHL - scheduled to receive one of 15 standard chemotherapy regimens - chemotherapy naive OR have received adjuvant therapy AND/OR have no more than one regimen of chemotherapy for metastatic disease - life expectancy of at least 3 months - ECOG performance status
    Exclusion Criteria:
    - known hypersensitivity to any of the products to be administered during dosing - primary prophylactic antibiotics in all cycles - prior radiation therapy within 2 weeks of randomization into this study or plan for radiation therapy during study participation, except for spot radiation for bony metastases - prior bone marrow or stem cell transplant or plan to receive any transplant therapy during study participation - clinically symptomatic brain metastases - Folstein mini-mental state exam score <18 - Any premalignant myeloid condition or any malignancy with myeloid characteristics - History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma, in situ cervical carcinoma or surgically cured malignancies - unstable/uncontrolled cardiac conditions or hypertension - active infection - subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving other investigational agents