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

NCT01374620 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-03-16

No results posted yet for this study

Summary

The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide.

Conditions

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

Sponsors & Collaborators

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Nicolas PENEL, MD · Centre Oscar Lambret

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-13
Primary Completion
2013-02-28
Completion
2013-04-30

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01374620 on ClinicalTrials.gov