drugset / Trial / NCT02469116

Carboplatin Plus Docetaxel With Day 2 Pegylated G-CSF (Neulasta®) in Patients With Advanced Stage Ovarian Carcinoma

NCT02469116 ↗

NaSingle-groupOpen-labelTreatment

Summary

In this study the investigators will be using an AUC of 6 based on creatinine clearance using the Carboplatin dosing formula used for Gynecologic Oncology Group protocols. Given that myelosuppression was significant using the docetaxel dose of 75 mg/m\*2 in the SCOTROC trial, the prophylactic use of pegylated G-CSF in this Phase II trial is warranted. The expectation would be that patients will be able to receive their cycles in a more timely fashion, with less delays, thereby allowing for improved outcomes and decreased hospitalizations due to myelosuppression.

Timeline

Start
2006-01
Primary completion
2009-08
Completion
2010-03

Outcome

Outcome not reported

Stopped (Business): “Sponsor withdrew financial support”

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 6 unknown Intravenous
Subject Docetaxel Small molecule — Intravenous
Subject Pegfilgrastim Protein / enzyme biologic — —

Indications