Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck

NCT00180921 | Unknown Phase 2

• 1 other identifier: CSTI BFR 17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II study of imatinib (Glivec) administered as a daily oral treatment in patients with recurrent/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT.

Conditions

Cancer of the Head and Neck; Carcinoma, Adenoid Cystic

Keywords

Adenoid cystic carcinoma of the head and neck

Outcome Measures

Primary Outcomes (1)

• To assess progression-free survival under treatment with imatinib mesylate in patients with relapsing/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT.

  at 6 months

Secondary Outcomes (1)

• The secondary objectives are to estimate the objective response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria), disease control and overall survival.

Interventions

Imatinib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven adenoid cystic carcinoma overexpressing KIT (by immunohistochemistry) with recurrent disease documented by computed tomography (CT) scan or magnetic resonance imaging (MRI).
• Presence of at least one dimensionally measurable target lesion (contrast enhancing lesion with the largest diameter \>= 2 cm, based on CT or MRI scan done within 4 weeks before the start of treatment).
• Patients able to swallow an oral compound.
• World Health Organization (WHO) performance status \< 2.
• Life expectancy of \>= 3 months.
• Aged \>= 18 years.
• Normal hematological (neutrophils \>= 1.5 x 10\^9 cells/l, platelets \>= 100 x 10\^9 cells/l), hepatic (bilirubin \< 1.5 times the upper limit of the normal range; alkaline phosphatase and transaminases \<= 2.5 x the upper limit of the normal range) and renal (serum creatinine \<= 150 mmol/l) functions.
• Written informed consent.

You may not qualify if:

• Abnormal cardiac function with history of ischaemic heart disease in the past 6 months and/or abnormal 12 lead electrocardiogram (ECG).
• Previous or current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma.
• Concomitant treatment with warfarin or any other anticoagulants.
• Unstable systemic diseases or active uncontrolled infections.
• Patients (male and female) not using effective contraception if of reproductive potential.
• Females pregnant or lactating or positive beta human chorionic gonadotropin (bHCG) at baseline

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Adenoid Cystic

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Sandrine Faivre, MD

  Centre Hospitalier de Beaujon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandrine Faivre, MD

CONTACT

33 1 40 87 50 25; s.faivre@bjn.aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: July 1, 2004
• Last Updated: September 26, 2007

Record last verified: 2006-09

Locations

FR (1)