Status:
UNKNOWN
Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Cancer of the Head and Neck
Carcinoma, Adenoid Cystic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
Patients with relapsing and/or metastatic adenoid cystic carcinoma of the salivary gland of the head and neck are usually poor responders to conventional cytotoxic chemotherapy. The investigation of ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00180921
Start Date
July 1 2004
Last Update
September 26 2007
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94800