Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

February 28, 2013

Study Completion Date

April 30, 2013

Conditions
Cancer
Interventions
DRUG

Paclitaxel dose escalation

"Paclitaxel will be administered intravenously over 60 minutes, at D1, D8 and D15, at a given dose.~The Paclitaxel dose (mg/infusion) levels are as follows:~* 40~* 60~* 70~* 75~* 80~* 85~* 90"

DRUG

Paclitaxel

Patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose in association with metronomic cyclophosphamide

DRUG

Cyclophosphamide

"D1 to D28: 50 mg x 2/day/cycle~1 cycle = 28 days"

BIOLOGICAL

Blood collection

At D1, D8, D15 and D21 of cycle 1 and cycle 2:2 blood samples for the correlation between clinical response and biological parameters

Trial Locations (1)

59000

Centre Oscar Lambret, Lille

All Listed Sponsors
lead

Centre Oscar Lambret

OTHER

NCT01374620 - Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel | Biotech Hunter | Biotech Hunter