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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

Information source: Hospices Civils de Lyon
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Breast Cancer

Intervention: Combination of Docetaxel (DTX) and Epirubicin (EPI) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hospices Civils de Lyon

Official(s) and/or principal investigator(s):
Gilles FREYER, Professor, Principal Investigator, Affiliation: Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud - Service d'oncologie médicale

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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Assessment of the risk of Dose-limiting Toxicities

Secondary outcome:

Plasma concentration of Docetaxel and Epirubicin after administration

Tumor response for each patient with one or more measurable lesions

Progression-free survival

Overall survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Age ≥ 18 years,

- ECOG performance status ≤ 2

- Diagnosed with metastatic HER2-negative hormone-resistant chemotherapy-naive breast

cancers, previous adjuvant chemotherapy treatment are allowed.

- Histologically or cytologically proven breast cancer metastases or associated with CA

15-3 levels 50% above the normal value

- Hormone resistance defined by the presence of negative hormone receptors or disease

progression within 6 months of the initiation of hormone therapy.

- Adequate renal and liver function (ASAT and ALAT < twice the upper limit normal value

(ULN) if no liver metastases, or < 4×ULN if liver metastases; total bilirubin < 2×ULN),

- Adequate cardiac function (left ventricular ejection fraction (LVEF) > 50%),

- Neutrophils ≥ 1200/mm3

- Platelets ≥ 105/mm3

Exclusion Criteria:

- Cerebral metastases and meningeal involvement,

- Other malignant diseases,

- Significant comorbidities,

- Previous chemotherapy for metastatic disease, or previous chemotherapy with a total

cumulative dose greater than 600 mg/m² for EPI or greater than 450 mg/m² for DTX

Locations and Contacts

Additional Information

Starting date: June 2005
Last updated: March 13, 2015

Page last updated: August 23, 2015

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