E1304 - Synopsis for Patients
ECOG trial number
ECOG E1304
Protocol title
Phase II Two Arm Trial of the Proteasome Inhibitor, PS-341 (VELCADE™) in Combination with Irinotecan or PS-341 Alone Followed by the Addition of Irinotecan at Time of Progression in Patients with Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Principal investigator
William Solomon, MD
Description
A study for patients with head and neck cancer that has recurred or spread to other sites in the body. Patients are assigned to receive one of the following 2 treatments randomly (by chance). It compares the effectiveness of these 2 treatments:
- Combination of PS-341 (Bortezomid, Velcade) and irinotecan to
- PS341 alone (followed by irinotecan if the cancer has grown larger while it has been treated with PS341 alone).
Purpose of study
Traditional chemotherapy has not been effective in treating head and neck cancer that has recurred or spread to other sites in the body.
In laboratory studies, PS-341 (bortezomid), which is a new type of chemotherapy drug, has shown effectiveness again head and neck cancers when it is used alone. It also has been showed that when PS-341 is added to traditional chemotherapy, it improves the effectiveness of traditional chemotherapy drug such as irinotecan.
The purpose of this study is to find out what effects (good and bad) PS-341 (Bortezomib, VelcadeTM) or the combination of two drugs, irinotecan and PS-341 has on you and your type of cancer.
You may be in the study if:
- You have cancer of the head of neck.
- You are 18 years of age or older.
To find out if you could be included in this study, please contact our staff . We will be happy to go over the eligibility criteria with you in details.
Head and Neck Cancer - ECOG E1304 - Patient Version
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