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Clinical Trials/EUCTR2008-004171-21-ES
EUCTR2008-004171-21-ESActive, not recruitingNot Applicable

Ensayo clínico en fase III de vinflunina más capecitabina frente a sólo capecitabina en pacientes con cáncer de mama avanzado previamente tratados con o resistentes a una antraciclina y que sean resistentes a taxanosA phase III trial of vinflunine + capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with or resistant to an anthracycline and who are taxane resistant

PIERRE FABRE MEDICAMENT0 sites764 target enrollmentStarted: January 27, 2009Last updated:
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Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
764
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Female

Inclusion Criteria

  • •- Patients must give written informed consent (personally signed and dated) before completing any study-related procedure.
  • •- Women with histologically or cytologically confirmed carcinoma of the breast.
  • •- Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy.
  • •- Patients must have received either one, two or three prior chemotherapy regimens including those administered in the neoadjuvant or adjuvant setting (sequential neoadjuvant/adjuvant treatment counting as one regimen.).
  • •- Prior treatments must have included both an anthracycline and a taxane.
  • •- Patients must have received a minimum cumulative dose of anthracycline (>or = 180 mg/m² of doxorubicin or ³ 300 mg/m² of epirubicin) or be resistant to an anthracycline according to the following criteria:
  • •a) Tumour progression while on anthracycline or within 4 months of the last anthracycline dose when given in the metastatic setting* or
  • •b) Recurrence while on anthracycline or within 12 months of the last anthracycline dose when given in the adjuvant or neoadjuvant setting*
  • •* Note: in addition to these criteria, to be considered resistant, a patient must have received at least 2 cycles of an anthracycline-based regimen
  • •- Patients must be resistant to taxane therapy according to the following criteria:
  • •a) Tumour progression while on taxane or within 4 months of last taxane dose when given in the metastatic setting** or,
  • •b) Recurrence while on taxane or within 12 months of the last taxane dose when given in the adjuvant setting or neoadjuvant setting**.
  • •** Note: in addition to these criteria, patients taken off taxane therapy for reasons other than progression (e.g. toxicity) must have received a minimum of 3 cycles.
  • •- Prior anti-cancer hormone therapy is allowed but the patient must no longer be candidate for hormone therapy. The treatment must be terminated 2 weeks prior to randomisation.
  • •- Patients who have been treated with anti Her2 targeted therapy (e.g. trastuzumab, lapatinib) must have discontinued therapy at least 4 weeks days prior to randomisation.
  • •- Prior radiation therapy is allowed to < 30% of the bone marrow and must be completed at least 4 weeks before randomisation.
  • •- Patient must have measurable disease according to RECIST.
  • •- Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of minor surgery, at least 3 weeks for major surgery.
  • •- Estimated life expectancy >or= 12 weeks.
  • •- Karnofsky performance score >or= 70 %.
  • •- Age >or= 21 years old.
  • •- Adequate haematological function as defined by absolute neutrophil count (ANC) >or= 1.5 x 109/L, platelet count >or= 100 x109/L and hemoglobin >or= 10 g/dL (within 7 days before first study treatment).
  • •- Adequate hepatic function as defined by: total bilirubin - Adequate renal function as defined by a calculated creatinine clearance >or= 50 mL/min according to Cockroft-Gault formula (ml/min) = [(0.85)(140-age)(weight)]/[(0.81)(SrCr µmol/L)] (within 7 days before first treatment administration).
  • •- ECG without clinically relevant abnormality (within 7 days before first treatment administration).
  • •- Patients on coumadin or warfarin must be on stable doses and have an International Normalized Ratio (INR) - Women

Exclusion Criteria

  • •- Patients with known or with clinical evidence of brain metastasis or leptomeningeal involvement.
  • •- Inflammatory breast cancer without evidence of metastatic disease.
  • •- Patients having received any other experimental or anti-cancer therapy within 30 days before randomisation except hormone therapy.
  • •- History of second primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non melanomatous carcinoma of the skin, and other malignancy treated at least 5 years previously with no evidence of recurrence.
  • •- Patients having as the sole tumour lesion, any of the following: malignant effusion, lymphangitis, cystic lesion, bone lesion; and any other lesion that is not assessed by imaging techniques or colour photography.
  • •- Patients with pre-existing motor/sensory peripheral neuropathy of CTCAE version 3.0 grade > 1.
  • •- Patients having received > 3 regimens of chemotherapy
  • •- Prior therapy with capecitabine and/or vinca alkaloids (including vinflunine).
  • •- History of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or any contra indication to any of the study drugs.
  • •- Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency.
  • •- Pregnant or breast feeding women.
  • •- Positive pregnancy test at inclusion.
  • •- Known history of HIV infection.
  • •- Inability to take and/or absorb oral medication including previous gastric surgery or any evidence of partial oesophageal, gastric, small or large bowel obstruction; gastrointestinal disorder that affect the absorption of capecitabine (malabsorption syndrome, 2/3 gastric resection and bowel resection).
  • •- Patients who have any serious, concurrent uncontrolled medical disorder especially uncontrolled hypercalcaemia, congestive heart failure, uncontrolled high-risk hypertension, arrhythmia, angina pectoris or previous history of myocardial infarction within 6 months prior to randomisation
  • •- Prior bone marrow transplantation or autologous stem cell infusion following high-dose chemotherapy.

Investigators

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