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

NCT00886132 | Completed Phase 2 DMC

• 1 other identifier: ACC-Siu 2006
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenoid Cystic Carcinoma; Salivary Gland Cancer

Keywords

Phase 2 Study; Sunitinib; Recurrent; Metastatic; Adenoid Cystic Carcinoma; Salivary Glands; Metastasis

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

Secondary Outcomes (1)

• 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.

  From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively.

Study Arms (1)

Sunitinib

EXPERIMENTAL

Patients with progressive, recurrent and/or metastatic ACC treated with sunitinib 37.5 mg daily in this single-arm, two-stage phase II trial.

Drug: Sunitinib

Interventions

Sunitinib DRUG

37.5 mg taken orally, daily every 28-day cycles

Also known as: Sutent, SU11248

Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic; Salivary Gland Neoplasms; Recurrence; Neoplasm Metastasis

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sebastien Hotte, MD

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 22, 2009
• Study Start: January 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 23, 2015

Record last verified: 2015-07

Locations

CA (1)