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An Open-Label, Randomised Study of Multi-Cycle, Dose Intensive Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood


Phase 2
18 Years
65 Years
Not Enrolling
Both
Breast Cancer, Lung Cancer, Ovarian Cancer

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Trial Information

An Open-Label, Randomised Study of Multi-Cycle, Dose Intensive Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood


Inclusion Criteria:

- Pathologically confirmed diagnosis of malignancy (solid tumour)
suitable for treatment with intensified carboplatin and paclitaxel - Previously untreated
with chemotherapy or radiotherapy - ECOG performance status 0 to 2 inclusive - Life
expectancy greater than or equal to 12 weeks - ANC greater than or equal to 2.0 x 10^9/L,
platelets greater than 100 x 10^9/L - Glomerular filtration rate greater than 60 mL/min
Exclusion Criteria: - Active infection requiring treatment with systemic (IV or oral)
anti-infectives (antibiotic, antifungal, antiviral) within 72 hours of randomisation -
Known to be HIV positive - Any premalignant myeloid condition or any malignancy with
myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous
leukaemia) - Prior malignancy within the last 5 years, with the exception of surgically
cured basal/squamous skin cell carcinoma, and/or carcinoma of the cervix in-situ - History
of impaired cardiac status [e.g., severe heart disease (NYHA greater than 2),
cardiomyopathy, or congestive heart failure] - Bone marrow involvement of disease - Major
surgery within 2 weeks before randomisation - Known sensitivity to E. coli derived drug
products (e.g., filgrastim) - Previous exposure to pegfilgrastim

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PBPC mobilization profiles and success rate of achieving planned chemotherapy administration on time.

Outcome Time Frame:

Cycle 0, and through 4 cycles

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

20010191

NCT ID:

NCT00117442

Start Date:

August 2002

Completion Date:

December 2004

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • Ovarian Cancer
  • solid tumour
  • unknown primary tumour
  • carboplatin
  • paclitaxel
  • Breast Neoplasms
  • Lung Neoplasms
  • Ovarian Neoplasms

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