Trial Information

Summary: A Phase 1 Study of S-1 Administered in Combination with Taxotere

Patients are being asked to participate in this research study if they have advanced solid tumors and they and their physicians have decided that treatment with Docetaxel is appropriate. Docetaxel is a drug approved by the U.S. Food and Drug Administration (FDA) for use in the treatment of breast cancer that has not responded to prior chemotherapy and in non-small cell lung cancer. For patients with cancer other than breast or non-small cell lung cancer, Docetaxel will be considered investigational. This research study uses an investigational drug called S-1 (taken orally) in combination with Docetaxel. S-1 is not approved by the FDA and its use in this study is experimental.

The purpose of this Phase 1, dose-escalation study is to determine what amount of S-1 can be safely administered to subjects when given with Docetaxel; this includes determining the dose-limiting toxicity and maximum tolerated dose of S-1 when given with Docetaxel. Administered in combination, the dose of Docetaxel will remain constant while the dose of S-1 will be increased (dose escalation) as more subjects enter the study until the maximum tolerated dose of S-1 with Docetaxel is determined. The study will also try to find out how the human body processes S-1 when given with Docetaxel, and that involves investigating the clinical pharmacokinetics (PK) of S-1. Pharmacokinetics look at how the body absorbs (takes drugs into the blood), distributes (delivers drug through the body), metabolizes (breaks down or processes the drug), and eliminates (removes) drugs.

Patient Inclusion Criteria:

• histologically proven advanced solid tumors where docetaxel therapy is appropriate
• has measurable and/or evaluable disease
• adequate bone marrow, liver and kidney function
• able to take medications orally

Not all eligibility criteria are listed. Additional criteria must be met in order to be eligible.

Patient Exclusion Criteria:

• has active brain mets
• concurrent malignancy
• uncontrolled diabetes mellitus
• uncontrolled heart conditions
• has had prior treatment with docetaxel (unless the patient responded to the previous regimen and the treatment-free interval is at least six months)
• had prior high-dose chemotherapy

If you would like to learn more about participating in this study, please send an e-mail message using the form below.