Phase II Pilot Study Assessing Efficacy of a Cisplatin - Métronomic Cyclophosphamide Treatment in Patients With Stade IV Triple Negative Breast Cancer Secondary Resistant to Anthracyclines and Taxanes
Information source: Centre Jean Perrin
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic Breast Cancer
Intervention: Cisplatin (Drug); Cyclophosphamide (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Centre Jean Perrin Overall contact: Jean-Marc NABHOLTZ, MD, MSc, Phone: 4-73-27-84-82, Ext: +33, Email: jmnabholtz@cjp.fr
Summary
Study assessing efficacy of a Cisplatine- Métronomic cyclophosphamide treatment in Patients
with Metastatic Triple Negative breast Cancer Secondary Resistant to Anthracyclines and
Taxanes.
Clinical Details
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Response rate of cisplatine - metronomic cyclophosphamide treatment
Secondary outcome: Disease free progressionSafety profile of cisplatin - metronomic cyclophosphamide association Overall survival Predictive factors to response and/or resistance treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Performance status < 2,
- Patient with metastatic breast cancer stade IV triple negative histologically
confirmed
- Measurable or not disease but radiologically evaluable (RECIST 1. 1),
- Negative Hormonal Receptors (Estrogens and/or Progesterone),
- HER-2 negative (Score 0 or 1 by Immunochemistry (IHC), negative FISH if score IHC 2),
- Patient exposed to anthracyclines and/or taxanes in neo-adjuvant or adjuvant setting,
- Patient with a progression and for whom anthracyclines and/or taxanes treatment
cannot be delivered and according to a resistance defined as :
- In the last 12 months after the last dose of taxanes or anthracyclines in adjuvant or
neoadjuvant setting or,
- During or after a first metastatic chemtotherapy line and where taxanes and
anthracyclines cannot be delivered according to :
- either a secondary resistance after an initial response to chemotherapy but a relapse
observed either during the treatment or in the 4 months after the end of
chemotherapy.
- either a sensitivity to treatment defined by a relapse after more than 4 months after
the first chemotherapy metastatic line,
- either intolerance to anthracyclines (doxorubicin 240-400 mg/m² ou equivalent to
doxorubicin (epirubicin) 300-550mg/m²)
- Patient non previously treated by platinum salts,
- Hematological Functions: Neutrophiles ≥ 1,5. 109/L, Platelets ≥ 100. 109/L, Leucocytes
> 3 000/mm3, Hb > 9g/dL, Hepatic Functions : total Bilirubin ≤ 1,5 time upper normal
value (UNV), ASAT ≤ 2 ,5 time UNV, ALAT ≤ 2,5 time UNV, Alkaline Phosphatase ≤ 2,5
time UNV (< 5 time UNV if case of hepatic metastasis), Renal Functions: Serum
Creatinine ≤ 1,5 time UNV (and if value > 1,5 time UNV, so Clearance ≥ 60 mL/min) or
Clearance ≥ 40 mL/min in case of RMI,
- Patient signed the consent study form,
- Patient affiliated to a social security regimen (law of 9 August 2004).
Exclusion Criteria:
- Male Patients,
- Unknown hormonal Receptors
- Positive HER-2 (Score 3 in IHC or positive FISH)
- Pregnant or breastfeeding patient, or in age of pregnancy or predicting to be
pregnant in the 6 months after the end of treatment,
- Patient not using contraceptive treatment during the treatment or after the 6 months
after the end of treatment,
- Patient is a ward,
- Patient suffering from a non compatible disease with the enrollment in the study,
- Cardiac, renal, medullar, respiratory or hepatic insufficiency, clinically
significant cardiovascular disease (including myocardiac infarct, unstable angina,
symptomatic congestive heart failure, uncontrolled cardiac arrhythmia) < 1 year
before the study enrollment or randomisation,
- Patient with pulmonary lymphangitis or symptomatic pleural effusion (grade≥2),
meningeal known carcinoma or symptoms of cerebromeningeal invasion, brain metastases
unless treatment and stability for at least 4 weeks (no steroids or anti-convulsive).
- Uncontrolled diabetes,
- Psychiatric or neurological significant abnormality,
- Peripheric Neuropathy > grade 2,
- Antecedent of hypersensibility to one of study treatment or one of used excipients,
- Urinary tract infection or acute hemorrhagic cystitis in progress
- Concomitant treatment with a medicine containing phenytoin or medication received in
the context of a trial, or participation in another therapeutic clinical trial within
<30 days prior treatment with chemotherapy.
- Geographically unstable patient in the next 6 months or remaining distance to the
treatment center making it difficult to follow in the study,
- Known history of abuse of narcotic or other drug or alcohol
- History of surgery within 28 days before the start of treatment,
- Patient unwilling or unable to comply with the requirements of the study.
Locations and Contacts
Jean-Marc NABHOLTZ, MD, MSc, Phone: 4-73-27-84-82, Ext: +33, Email: jmnabholtz@cjp.fr
Centre Hospitalier Henri Mondor, Aurillac 15000, France; Recruiting Jean-Marc NABHOLTZ, MD, MSc, Phone: +33473278482, Email: jmnabholtz@cjp.fr Nassera CHALABI, PhD, Phone: +33473278454, Email: nassera.chalabi@cjp.fr Jean-Marc NABHOLTZ, MD, MSc, Principal Investigator Daniela BURLACU, MD, Sub-Investigator
Centre Médico-Chirurgical Les Tronquières, Aurillac 15000, France; Recruiting Michel KAREH, MD, Phone: +33471043336, Email: drmichelkareh@yahoo.fr Michel KAREH, MD, Principal Investigator
Centre Jean Perrin, Clermont-Ferrand 63011, France; Recruiting Jean-Marc NABHOLTZ, MD, MSc, Phone: 4-73-27-84-82, Ext: +33, Email: jmnabholtz@cjp.fr Nasséra CHALABI, PhD, Phone: 4-73-27-84-54, Ext: +33, Email: nassera.chalabi@cjp.fr Jean-Marc NABHOLTZ, MD, MSc, Principal Investigator Mohun R.K. BAHADOOR, MD, Sub-Investigator Philippe CHOLLET, MD, PhD, Sub-Investigator Marie-Ange MOURET-REYNIER, MD, Sub-Investigator Pascale DUBRAY-LONGERAS, MD, Sub-Investigator Isabelle VAN PRAAGH-DOREAU, MD, Sub-Investigator Daniela BURLACU, MD, Sub-Investigator
Centre Hospitalir Emile Roux, Le Puy-en-Velay 43000, France; Recruiting Jean-Marc NABHOLTZ, MD, MSc, Phone: +33473278482, Email: jmnabholtz@cjp.fr Nassera CHALABI, PhD, Phone: +33473278454, Email: nassera.chalabi@cjp.fr Jean-Marc NABHOLTZ, Md, MSc, Principal Investigator Brigitte MONANGE, MD, Sub-Investigator
Centre Hospitalier de Montluçon, Montluçon 03100, France; Recruiting Jean-Marc NABHOLTZ, MD, MSc, Phone: +33473278482, Email: jmnabholtz@cjp.fr Nassera CHALABI, PhD, Phone: +33473278454, Email: nassera.chalabi@cjp.fr Jean-Marc NABHOLTZ, MD, MSc, Principal Investigator Pascale DUBRAY-LONGERAS, MD, Sub-Investigator
Additional Information
Starting date: July 2013
Last updated: October 1, 2014
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