Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck
Recruitment status was Recruiting
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.
Cancer of the Head and Neck
Carcinoma, Adenoid Cystic
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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. [ Time Frame: at 6 months ]
- The secondary objectives are to estimate the objective response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria), disease control and overall survival.
|Study Start Date:||July 2004|
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 proliferation pathways involving tyrosine kinase receptors such as c-kit receptor (KIT) and PDGF receptor may allow to identify a molecular target for novel therapeutic approaches in patients with adenoid cystic carcinoma who failed locoregional treatment.
Several publications in the literature and the pathological study we conducted in Institut Gustave Roussy show that KIT overexpression is observed in at least 80-90% of the cases of adenoid cystic carcinoma, supporting the investigation of imatinib in patients with adenoid cystic carcinoma overexpressing KIT.
Imatinib is an orally administrated, well tolerated compound that could be given on an outpatient schedule to patients with relapsing/metastatic adenoid cystic carcinoma of the head and neck.
Because of the infrequent occurrence of salivary gland malignancies, a multicenter trial will be mandatory and the study will include at least 2 centers represented by Institut Gustave Roussy, Villejuif; and Hôpital Georges-Pompidou, Paris.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180921
|Contact: Sandrine Faivre, MD||33 1 40 87 50 firstname.lastname@example.org|
|Institut Gustave Roussy||Recruiting|
|Villejuif, France, 94800|
|Contact: Sandrine Faivre, MD 33 1 40 87 50 25 email@example.com|
|Contact: Caroline Robert, MD 33 1 42 11 42 53 firstname.lastname@example.org|
|Principal Investigator:||Sandrine Faivre, MD||Centre Hospitalier de Beaujon|