E3395 – Trial Results Summary for Patients

Title

Using A Four-Day, Continuous Dose of Paclitaxel to Treat Patients With Advanced Head and Neck Cancer (A Phase II Trial)

Sponsor

Eastern Cooperative Oncology Group through the NCI-sponsored Cancer Cooperative Group Program

Purpose of the Study

The purpose of this study was to evaluate the effectiveness and safety of the anticancer drug, paclitaxel, given continuously for four days, to treat patients with head and neck cancer that had returned after treatment or had spread beyond the head and neck.

Results

Among patients with no prior chemotherapy there were two patients who responded: one with a complete response and one person with partial response (13 percent). Half the patients in the study were still alive after 5.5 months (median survival). The survival rate one year after the study began was 10 percent. This treatment schedule was not considered effective enough for further study.

Start Date

February 1997

Stop Date

July 2000

Number of Participating Patients

50

Eligibility Requirements

Patients were at least 18 years old and had measurable head or neck cancer that was not treatable with surgery or radiation. One group of patients had no previous chemotherapy treatment; another had previous chemotherapy with paclitaxel; another had chemotherapy using other anticancer drugs.

Study Design

Patients received the anticancer drug paclitaxel through a needle in a vein continuously for four days, either in the hospital or as an outpatient. This treatment was repeated every three weeks for up to 12 three-week cycles. If the cancer got worse, treatment was stopped.

Side Effects

The most severe side effects experienced were blood cell abnormalities, including one treatment-related death from infection due to pneumonia.

Additional Information at ClinicalTrials.gov

NCT00002922