Sunitinib in Refractory Adrenocortical Carcinoma

Learn more about:
Related Clinical Trial
The Impact of Mitotane Therapy on Serum Free Proteins in Patients With Adrenocortical Carcinoma Phase II Trial of Pembrolizumab Plus Lenvatinib in Advanced Adrenal Cortical Carcinoma Natural History Study of Children and Adults With Adrenocortical Cancer (ACC) Nivolumab Combined With Ipilimumab for Patients With Advanced Rare Genitourinary Tumors Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors Natural History Study of Infants With Adrenal Masses Found on Prenatal and/or Neonatal Imaging Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor International Pediatric Adrenocortical Tumor Registry Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer Structured Evaluation of adRENal Tumors Discovered Incidentally – Prospectively Investigating the Testing Yield Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy Sorafenib Plus Paclitaxel in Adreno-Cortical-Cancer Patients Efficacy of Adjuvant Mitotane Treatment (ADIUVO) Possible New Therapy for Advanced Cancer IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery Studying Genes in Samples From Younger Patients With Adrenocortical Tumor Single Agent Pembrolizumab in Subjects With Advanced Adrenocortical Carcinoma Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery Evaluation of Side Effects of Mitotane Optimal Methods of Disease Progression and Survival Analysis in Children and Adults Patients With Adrenocortical Cancer (ACC) Surgery and Heated Chemotherapy for Adrenocortical Carcinoma Sunitinib in Refractory Adrenocortical Carcinoma Nivolumab in Treating Patients With Metastatic Adrenocortical Cancer Phase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma Adjuvant Chemotherapy vs. Observation/Mitotane After Primary Surgical Resection of Localized Adrenocortical CarcInoma A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma S9427, Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery Natural History and Tissue Acquisition Study of Adrenocortical Carcinoma Cabozantinib in Advanced Adrenocortical Carcinoma Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma German Adrenocortical Carcinoma Registry Clinical Trial of Dovitinib in First-line Metastatic or Locally Advanced Non-resectable Adrenocortical Carcinoma

Brief Title

Sunitinib in Refractory Adrenocortical Carcinoma

Official Title

Sunitinib in Refractory Adrenocortical-Carcinoma Patients Progressing After Cytotoxic Chemotherapy

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 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.

Study Phase

Phase 2

Study Type


Primary Outcome

Assessment of Clinical Benefit Due to Treatment With Sunitinib

Secondary Outcome

 Assessment of Objective Response Rates


Adrenocortical Carcinoma



Study Arms / Comparison Groups

Description:  Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off.
treatment will continue until progressive disease or unacceptable toxicity


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

July 2007

Completion Date

February 2012

Primary Completion Date

August 2011

Eligibility 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

          -  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,

               -  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

          -  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




18 Years - N/A

Accepts Healthy Volunteers



Martin Fassnacht, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

University of Wuerzburg



Study Sponsor

Martin Fassnacht, MD, Principal Investigator, University of Wuerzburg

Verification Date

August 2018