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A Pilot Dose Escalation Trial of a Densified Chemotherapy Association of Docetaxel and Epirubicin Driven by Mathematical Modeling in Metastatic Breast Cancer Patients: The MODEL1 Study

NCT02392845 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2015-03-19

No results posted yet for this study

Summary

To determine the maximum tolerated dose of a densified regimen of the association of docetaxel (DTX) and epirubicin (EPI), supported by the concomitant administration of hematopoietic growth factors in patients with metastatic breast cancer in first-line, optimizing in each patient the administration schedule using a formal procedure based on mathematical models in order to manage the severity of induced neutropenia.

The models used in this project allow:

* an optimal administration schedule of the planned total dose per cycle (number of infusions and calculating their rates and durations)
* an individualization of the administration schedule from the second cycle (based on observations from the first cycle), and
* an assessment of the risk of a dose-limiting toxicity event combining several severe non-hematological toxicities (conditioning the decision for dose escalation).

Using formal mathematical models the investigators expect controlling the hematological and non-hematological toxicities in order to realize the full series of six cycles of densified DTX+EPI chemotherapy (2 weeks per cycle) for each patient. For each patient, chemotherapy is considered feasible if it is possible, in the absence of tumor progression, to consider 6 cycles of treatment without observing any serious adverse events and without:

* patient death that may be related to the treatments;
* decision of the patient to interrupt treatment for physical or psychological tolerance reasons;
* decision of the investigator to discontinue treatment, in the absence of disease progression.

Conditions

Interventions

DRUG

Combination of Docetaxel (DTX) and Epirubicin (EPI)

Six cycles of densified DTX+EPI chemotherapy (2 weeks per cycle) for each patient

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Gilles FREYER, Professor · Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud - Service d'oncologie médicale

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2009-03-31
Completion
2009-03-31

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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 NCT02392845 on ClinicalTrials.gov