E2595 – Trial Results Summary for Patients

Title

Using Taxotere® To Treat Malignant Mesothelioma (A Phase II Study)

Sponsor

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

Purpose of the Study

The purpose of this study was to test the effectiveness of docetaxel (also called Taxotere) in treating patients with malignant mesothelioma, a type of lung cancer. The study evaluated survival rates and side effects of this treatment.

Results

Median survival was four months; only one patient (5 percent) had a partial response to this treatment.

Conclusion

This study found docetaxel alone was not effective in treating malignant mesothelioma.

Start Date

November 1996

Stop Date

February 1998

Number of Participating Patients

20

Eligibility Requirements

Patients had malignant mesothelioma that could not be treated with surgery or radiation and that doctors were able to measure or evaluate using diagnostic tests. Patients had no prior chemotherapy; surgery must have been done more than two weeks before entering the study and radiation more than four weeks before entering the study. General health factors were also considered.

Study Design

The study treatment was designed to be given in six, three-week cycles. Patients received a one-hour infusion of docetaxel through a needle in a vein every three weeks. Dexamethasone was given, by mouth during the treatment cycle to prevent allergic reactions and swelling. Patients were treated until side effects became too severe or their disease got worse. Patients were evaluated for response after every two cycles. Those whose disease did not get worse continued treatment every three weeks for six cycles and were then allowed to go off treatment, at the investigator’s discretion. Patients whose disease got worse discontinued treatment.

Side Effects

Reduction in white cell counts was the most common side effect. Patients experienced lowered blood counts. There were three treatment-related deaths.