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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 progression

Safety 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

Page last updated: August 23, 2015

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