45
Participants
Start Date
May 1, 2012
Primary Completion Date
May 5, 2021
Study Completion Date
May 5, 2021
Combination Chemotherapy
"4 cycles of: Day 1 Actinomycin D 1mg/m2, Paclitaxel 80mg/m2, Methotrexate Day 4 Oxaliplatin 100mg/m2 Pegfilgrastim 6mg Day 8\* Paclitaxel 80mg/m2 Day 15 Paclitaxel 80mg/m2~\*Day 8 will be omitted for the first three patients treated in this study and will be given at the end of treatment in a fifth cycle where Paclitaxel 80mg/m2 will be administered on Days 1, 8, 15 and 22. Before adding the extra Paclitaxel 80mg/m2 dose on day 8 the safety data for these patients will be reviewed by a DMC.~NB This 5th cycle for patients 1-3 has been included to ensure that the four 'missed doses of paclitaxel are not omitted from the patients treatment regimen. Cycles 1-4 are 21 days cycles; Cycle 5 (for the first three patients only) is a 28 day cycle."
St Bartholomew's Hospital, London
Barts & The London NHS Trust
OTHER