Last updated on April 2018

Cabazitaxel Activity in Patients With Advanced AdrenoCortical-Carcinoma Progressing After Previous Chemotherapy Lines

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Adrenocortical carcinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Histologically confirmed diagnosis of ACC
  • Locally advanced or metastatic disease not amenable to radical surgery resection
  • Radiologically monitorised disease
  • Progressing disease after one to three cytotoxic chemotherapy regimes (including a platin-based protocol)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy 3 months
  • Age 18 years
  • Adequate bone marrow reserve (neutrophils 1500/mm and platelets > 100.000/mm)
  • Effective contraception in pre-menopausal female and male patients
  • Patients written informed consent
  • Ability to comply with the protocol procedures
  • Mitotane intake should be stopped one months before the study entry

Exclusion Criteria:

  • History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years.
  • Serum creatinine > 1.5 x ULN or hepatic insufficiency, Hemoglobin <10.0 g/dL;
  • Total bilirubin >1x ULN, Creatinine < 1.5 ULN;
  • Decompensated heart failure (ejection fraction <45%), myocardial infarction or revascularization procedure during the last 6 months, unstable angina pectoris, uncontrolled cardiac arrhythmia
  • Pregnancy or breast feeding
  • Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
  • Patients with serum levels of mitotane (evaluated one week before the study start) in the therapeutic range (14-20 mcg/ml).History of severe hypersensitivity reaction (grade 3) to docetaxel
  • History of severe hypersensitivity reaction (grade 3) to polysorbate 80 containing drugs
  • Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Annex 1 and Annex 2)
  • Concomitant vaccination with yellow fever vaccine

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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