A Study of Sunitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Health Network, Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00886132
First received: April 20, 2009
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

This is a phase II study to evaluate the effectiveness of study drug sunitinib malate in patients with recurrent and/or metastatic adenoid cystic carcinomas of the salivary gland. There currently is not standard of care for this type of cancer and it has hoped that sunitinib will have antitumor effects on patients with this type of cancer.


Condition Intervention Phase
Adenoid Cystic Carcinoma
Salivary Gland Cancer
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Sunitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To determine the antitumor activity of sunitinib in recurrent and/or metastatic adenoid cystic carcinoma of the salivary glands using objective response rates (partial and complete responses). [ Time Frame: Changes in tumor measurements must be confirmed by repeat assessments that should be performed not less than 4 weeks after the criteria for response are first met. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the duration of objective response, rate and duration of stable disease, progression-free, median and overall survival rates of sunitinib in recurrent and/or metastatic adenoid cystic carcinoma of the salivary glands. [ Time Frame: From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively. ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sunitinib
    37.5 mg taken orally, daily every 28-day cycles
    Other Name: Sutent, SU11248
Detailed Description:

This is an open-label phase II study of sunitinib malate in patients with recurrent and/or metastatic adenoid cystic carcinomas (ACC) of major or minor salivary gland origin. Sunitinib is a novel, multi-targeted small molecule inhibitor of the receptor tyrosine kinases (RTKs), including vascular endothelial growth factor receptors (VEGFs), platelet derived growth factor receptors (PDGFRs) and stem cell factor receptor (KIT), that are involved in tumour proliferation and angiogenesis. VEGF expression has been associated clinically with disease prognosis in many different types of cancers and a number of studies have suggested that VEGF may play an important role in the pathogenicity of ACC. Sunitinib is expected to inhibit PDGF- and VEGF-driven angiogenesis and, as a consequence, limit solid tumour growth.This study will determine the anti-tumour activity of sunitinib in ACC of the salivary glands using objective response rates (partial and complete responses) as its primary objective.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients must have histologic or cytologic adenoid cystic carcinomas of major or minor salivary gland origin.
  • Patients must have recurrent and/or metastatic disease that is progressive and not amenable to surgery or curative radiotherapy occurring within 6 months of study entry:

    • at least a 20% increase in radiologically or clinically measurable disease;
    • appearance of any new lesions or
    • deterioration in clinical status
  • Patients must have measurable disease, at least one lesion that can be accurately measured in at least one dimension as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
  • Patients with prior therapy with at least a 4 weeks' interval between any chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy or surgery and study enrollment. Exceptions may be made for low dose, non-myelosuppressive radiotherapy.
  • Patients must be 18 years of age or older.
  • Life expectancy of greater than 12 weeks.
  • Patients must have normal organ and marrow function as defined below:

    • leukocytes >3,000/μL
    • absolute neutrophil count >1,500/μL
    • platelets >100,000/μL
    • total bilirubin within normal institutional limits
    • AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
    • amylase/lipase within normal institutional limits
    • creatinine within normal institutional limits
    • creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • Cardiac ejection fraction within the institutional range of normal as measured by ECHO or MUGA scan.
  • Patients must have QTc < 500 msec on baseline ECG.
  • Patients with New York Heart Association (NYHA) Class II cardiac function:

    • with a history of Class II heart failure who are asymptomatic on treatment
    • with prior anthracycline exposure
    • who have received central thoracic radiation that included the heart in the radiotherapy port.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. At least 4 weeks must have elapsed since any major surgery.
  • Patients receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib.
  • Patients with QTc prolongation or other significant ECG abnormalities.
  • Patients with poorly controlled hypertension.
  • Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis. Note: Low molecular weight heparin is permitted provided the patient's PT INR is <1.5.
  • Patients with any condition that impairs their ability to swallow and retain sunitinib tablets.
  • Patients with any of the following conditions:

    • Serious or non-healing wound, ulcer, or bone fracture.
    • History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 28 days of treatment.
    • Any history of cerebrovascular accident or transient ischemic attack within 12 months prior to study entry.
    • History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry.
    • History of pulmonary embolism within the past 12 months.
    • Class III or IV heart failure as defined by the NYHA.
  • Patients taking medications that are potent inducers or inhibitors of the CYP3A4 liver enzyme (unless deemed acceptable by the Principal Investigator).
  • Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication.
  • Patients with known brain metastases.
  • Patients with uncontrolled intercurrent illness including, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women. Breastfeeding should be discontinued if the mother is treated with sunitinib.
  • HIV-positive patients on combination antiretroviral therapy
  • Patients taking any of the medications that may cause QTc prolongation unless the required washout period has been met.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886132

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Sebastien Hotte, MD Juravinski Cancer Centre
  More Information

No publications provided

Responsible Party: Dr. Sebastien Hotte, Juravinski Cancer Centre
ClinicalTrials.gov Identifier: NCT00886132     History of Changes
Other Study ID Numbers: ACC-Siu 2006
Study First Received: April 20, 2009
Last Updated: June 18, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Phase 2 Study
Sunitinib
Recurrent
Metastatic
Adenoid Cystic Carcinoma
Salivary Glands
Metastasis

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Adenoid Cystic
Salivary Gland Neoplasms
Adenocarcinoma
Head and Neck Neoplasms
Mouth Diseases
Mouth Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Salivary Gland Diseases
Stomatognathic Diseases
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014