Sunitinib in Refractory Adrenocortical-Carcinoma patients progressing after cytotoxic chemotherapy (SIRAC) - SIRAC

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Histologically confirmed diagnosis of ACC
•Locally advanced or metastatic disease not amenable to radical surgery resection
•Radiologically monitorable disease
•Progressing disease after one to three cytotoxic chemotherapy regimes including a platin-based protocol
•ECOG performance status 0-2
•Life expectancy = 3 months
•Age = 18 years
•Adequate bone marrow reserve (neutrophils = 1500/mm³ and platelets =100.000/mm³, and haemoglobin = 9g/dl)
•Negative pregnancy test and effective contraception in pre-menopausal female and male patients
•Patient´s written informed consent
•Ability to comply with the protocol procedures

If patients have been participated in another clinical trial evaluating treatment options for ACC (e.g. FIRM-ACT), the patient can only be included in the SIRAC trial, if:
•the patient has discontinued study treatment of the previous trial according to the protocol
•or the study chair of the previous trial gives written approval for inclusion of this individual patient in the SIRAC trial.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.
•Severe renal (serum creatinine > 2.5 x ULN) or hepatic insufficiency (ALT / AST > 2.5 x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.0 x ULN) and/or serum albumin < 3g/dl
•Any of the following within the 8 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, or other severe thromboembolic event.
•Ongoing cardiac dysrhythmias of NCI CTCAE grade ?2, acute atrial fibrillation of any grade, or prolongation of the QTc interval to >470 msec for females
•Left ventricular ejection fraction (LVEF) ?45% as measured by echocardiogram
•NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment
•Hypertension that cannot be controlled by medications (>160/100 mmHg despite optimal medical therapy)
•Pregnancy or breast feeding
•Previous treatment with Sunitinib or any other VEGF- or PDGF-pathway directed agent.
•Current treatment with strong CYP3A4 inhibitors or –inducers
•Current treatment with another investigational drug
•Current treatment with another anti-cancer drug
•Patients with ileus within the last 28 days
•Major surgery, radiation therapy, or systemic therapy within 3 weeks of first study treatment. At least 7 days should elapse from the time of minor surgical procedure including placement of an access device or fine needle aspiration before start of study treatment
•Serious wounds that have not completely healed, active ulcer(s), or significant bone fracture(s).
•Prior radiation therapy to >25% of the bone marrow.
•Cachectic patients with a body mass index < 18 kg/m2
•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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effects of Sunitinib in patients with advanced ACC progressing after cytotoxic chemotherapy, primary to demonstrate a response rate of more than 5% and to estimate the response rate with confidence;Secondary Objective: •Assessment of objective (complete and partial) response rates (ORR) and assessment of duration of response (DR)<br>•Assessment of progression-free survival<br>•Assessment of overall survival<br>•Assessment of the relationship between specific biomarker” and cancer- and treatment-related outcomes<br>•Assessment of quality of life by EORTC QLQ-C30<br>•Assessment of toxicity <br>;Primary end point(s): Progression-free survival of = 12 weeks defined as a response

Secondary Outcome Measures

Name	Time	Method

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