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Phase II Pilot Study Assessing Efficacy of a Cisplatin - Metronomic Cyclophosphamide Treatment in Patients With Metastatic Triple Negative Breast Cancer Resistant to Anthracyclines and Taxanes

This study has been terminated.
(Because of difficulties in recruiting)
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT01910870
First received: May 28, 2013
Last updated: October 10, 2016
Last verified: July 2016
  Purpose
To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.

Condition Intervention Phase
Metastatic Breast Cancer
Drug: Cisplatin
Drug: Metronomic Cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Centre Jean Perrin:

Primary Outcome Measures:
  • Response rate of cisplatin - metronomic cyclophosphamide treatment [ Time Frame: 18 months and 6 weeks ]

Secondary Outcome Measures:
  • Disease free progression [ Time Frame: 3 years ]
  • safety profile of cisplatin - metronomic cyclophosphamide association [ Time Frame: 18 months and 6 weeks ]
    Number of Participants with Adverse Events

  • Overall survival [ Time Frame: 5 years ]
  • Predictive factors to response and/or resistance treatment [ Time Frame: 18 months and 6 weeks ]

Enrollment: 4
Study Start Date: July 2013
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin - Metronomic Cyclophosphamide
Cisplatin 25 mg/m² (day 1 to day 3) every 3 weeks Metronomic cyclophosphamide 150 mg (day 1 to day 14) every 3 weeks
Drug: Cisplatin
25 mg/m² I.V. (day 1 to day 3) Total dose : 75 mg/m² every 3 weeks
Drug: Metronomic Cyclophosphamide
150 mg per os from day 1 to day 14 (total dose = 2100 mg) every 3 weeks
Other Name: Endoxan

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 ans,
  • 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 with a progression during or after an anthracyclines and/or taxanes treatment receiving in neo-adjuvant or adjuvant regimen according to a resistance defined as a documented disease progression in the last 12 month after the last dose of taxanes or anthracyclines,
  • 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: Creatinine Clearance ≥ 60 mL/min,
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910870

Locations
France
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Sponsors and Collaborators
Centre Jean Perrin
Investigators
Principal Investigator: Marie-Ange MOURET-REYNIER, MD Centre Jean Perrin
  More Information

Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT01910870     History of Changes
Other Study ID Numbers: META1 - CJP4.1
Study First Received: May 28, 2013
Last Updated: October 10, 2016

Keywords provided by Centre Jean Perrin:
Early-relapse

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cisplatin
Cyclophosphamide
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists

ClinicalTrials.gov processed this record on April 26, 2017