E1C97 – Trial Results Summary for Patients

Title

Using Octreotide With or Without the Addition of Prednisone to Treat Patients With Advanced or Recurrent Thymoma Who Could Not Be Helped With Conventional Surgical, Radiation or Chemotherapy Treatment (A Phase II Trial)

Sponsor

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

Purpose of the Study

Thymoma is a tumor located behind the top of the breastbone. The purpose of this study was to evaluate the anticancer effect of a drug called octreotide, either alone or with another drug, prednisone, in treating patients with thymoma that has returned or spread to other parts of the body.

Results

The study found that octreotide alone has a modest anticancer effect in patients with certain types of thymoma. A complete response, meaning no remaining cancer was detected, was experienced by 5.3 percent of patients in the study. Of patients receiving octreotide alone, 10.5 percent experienced a measurable response. The addition of prednisone increased the response rate to 31.6 percent, but prednisone can cause harmful side effects. Further studies of octreotide would provide additional information.

Conclusion

Given the modest tumor response seen in this study, no subsequent clinical trials with octreotide are planned by ECOG in the immediate future. However, tissue collected in the study will be evaluated to identify any factors that might indicate a better response to drugs like octreotide.

Start Date

April 1998

Stop Date

November 2000

Number of Participating Patients

38

Eligibility Requirements

Patients who participated in the study were at least 18 years old and had thymic tumors that could be measured by standards set for the study.

Study Design

Patients received injections of octreotide under the skin three times a day for two months. Patients whose disease responded to this treatment continued monthly cycles of treatment for one year. Patients whose disease remained the same received prednisone orally in addition to the octreotide for one year.

Side Effects

The most common side effects for the drugs used in this study were abdominal pain, diarrhea, nausea, vomiting, fatigue, anxiety, lowering of blood counts, and elevation of blood sugar.

Additional Information at ClinicalTrials.gov

NCT00003283