Status:
COMPLETED
Sunitinib in Refractory Adrenocortical Carcinoma
Lead Sponsor:
University of Wuerzburg
Collaborating Sponsors:
Pfizer
Conditions:
Adrenocortical Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Although a first randomized trial in patients with advanced ACC leading to the establishment of a first line cytotoxic chemotherapy is ongoing (FIRM-ACT), the failure rate even of this FIRM-ACT study ...
Eligibility Criteria
Inclusion
- 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 ≥ 9 g/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.
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.
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00453895
Start Date
July 1 2007
End Date
February 1 2012
Last Update
January 31 2019
Active Locations (2)
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1
Charite Berlin
Berlin, Germany
2
Dept. of Medicine I, University of Wuerzburg
Würzburg, Germany, 97080