Status:
UNKNOWN
Cabazitaxel Activity in Patients With Advanced AdrenoCortical-Carcinoma Progressing After Previous Chemotherapy Lines
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborating Sponsors:
San Luigi Gonzaga Hospital
Conditions:
Adrenocortical Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Adrenocortical cancer (ACC) is a rare aggressive tumor. The treatment of metastatic ACC is challenging and the current available treatments are mitotane, chemotherapy or the combination of both. Progn...
Detailed Description
CABAZITAXEL ADMINISTRATION Cabazitaxel will be administered at dose of 25 mg/m2 every 3 weeks, administered by IV route in 1 hour, for a maximum of 6 total cycles. The drug will be provided by Sanofi ...
Eligibility Criteria
Inclusion
- 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/mm³ and platelets \> 100.000/mm³)
- Effective contraception in pre-menopausal female and male patients
- Patient´s written informed consent
- Ability to comply with the protocol procedures
- Mitotane intake should be stopped one months before the study entry
Exclusion
- 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
Key Trial Info
Start Date :
January 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 24 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03257891
Start Date
January 25 2018
End Date
January 24 2022
Last Update
April 11 2018
Active Locations (1)
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1
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25123