Trial document




This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004039

Trial Description

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Title

Sunitinib in Refractory Adrenocortical-Carcinoma Patients Progressing After Cytotoxic Chemotherapy

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Trial Acronym

SIRAC

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URL of the Trial

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Brief Summary in Lay Language

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 is most likely clearly above 50%. Therefore, the majority of participating
patients urgently need a new treatment option. However, up to date there is no evidence for
a single regimen that might be promising in these treatment-refractory patients with ACC.

Sunitinib is an oral multitargeted tyrosine kinase inhibitor with anti-tumor and
antiangiogenic activities, which is successfully tested in the treatment of patients with
metastatic renal cell carcinoma, gastrointestinal stromal and neuroendocrine tumors after
failure of standard cytotoxic chemotherapy.

The primary objective of this trial is to estimate the response (defined as progression-free
survival of ≥ 12 weeks) rate associated with Sunitinib treatment in patients advanced ACC
progressing after cytotoxic chemotherapy.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004039
  •   2012/07/27
  •   2007/03/28
  •   yes
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Secondary IDs

  •   NCT00453895  (ClinicalTrials.gov)
  •   SIRAC-1  (University of Wuerzburg)
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Health Condition or Problem studied

  •   Adrenocortical Carcinoma
  •   C74.0 -  Malignant neoplasm: Cortex of adrenal gland
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Interventions/Observational Groups

  •   Drug: Sunitinib
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- Assessment of clinical benefit as measured by non progressing rate after 12 weeks of treatment with Sunitinib

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Secondary Outcome

- Assessment of Objective Response Rates (ORR) and duration of response (DR)
- Assessment of progression-free survival
- Assessment of overall survival
- Assessment of the relationship between specific "biomarker" and cancer- and treatment-related outcomes
- Assessment of quality of life by EORTC QLQ-C30
- Assessment of toxicity

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2007/07/31
  •   36
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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 ≥ 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.

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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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Wuerzburg
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    • University of Wuerzburg
    • Martin Fassnacht, MD 
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    • University of Wuerzburg
    • Martin Fassnacht, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.