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Sunitinib in Refractory Adrenocortical Carcinoma (SIRAC)
This study is currently recruiting participants.
Verified by University of Wuerzburg, February 2009
First Received: March 28, 2007   Last Updated: February 13, 2009   History of Changes
Sponsors and Collaborators: University of Wuerzburg
Pfizer
Information provided by: University of Wuerzburg
ClinicalTrials.gov Identifier: NCT00453895
  Purpose

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.


Condition Intervention Phase
Adrenocortical Carcinoma
Drug: Sunitinib
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Sunitinib in Refractory Adrenocortical-Carcinoma Patients Progressing After Cytotoxic Chemotherapy

Resource links provided by NLM:


Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:
  • Assessment of clinical benefit as measured by non progressing rate after 12 weeks of treatment with Sunitinib

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 36
Study Start Date: July 2007
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453895

Contacts
Contact: Martin Fassnacht, MD 49-931-201-36507 fassnacht_m@medizin.uni-wuerzburg.de
Contact: Marcus Quinkler, MD 49-30-450-514259 marcus.quinkler@charite.de

Locations
Germany
Dept. of Medicine I, University of Wuerzburg Recruiting
Wuerzburg, Germany, 97080
Contact: Martin Fassnacht, MD     49-931-201-36507     fassnacht_m@medizin.uni-wuerzburg.de    
Principal Investigator: Martin Fassnacht, MD            
Charite Berlin Recruiting
Berlin, Germany
Contact: Marcus Quinkler, MD     49-30-450-514259     marcus.quinkler@charite.de    
Principal Investigator: Marcus Quinkler, MD            
Sponsors and Collaborators
University of Wuerzburg
Pfizer
Investigators
Principal Investigator: Martin Fassnacht, MD University of Wuerzburg
  More Information

Additional Information:
No publications provided

Study ID Numbers: SIRAC-1
Study First Received: March 28, 2007
Last Updated: February 13, 2009
ClinicalTrials.gov Identifier: NCT00453895     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Wuerzburg:
Adrenal cancer refractory to cytotoxic therapy
Sunitinib
Multitargeted tyrosine-kinase inhibitor

Study placed in the following topic categories:
Adrenocortical Carcinoma
Tyrosine
Adrenal Gland Diseases
Endocrine System Diseases
Angiogenesis Inhibitors
Carcinoma
Adrenal Gland Neoplasms
Sunitinib
Adrenal Cancer
Adrenal Cortex Neoplasms
Endocrinopathy
Epinephrine
Adenocarcinoma
Adrenal Cortex Diseases
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Adrenocortical Carcinoma
Physiological Effects of Drugs
Adrenal Gland Diseases
Endocrine System Diseases
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Adrenal Gland Neoplasms
Neoplasms by Site
Sunitinib
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Adrenal Cortex Neoplasms
Adenocarcinoma
Adrenal Cortex Diseases
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009