A Randomized Phase III Trial of Paclitaxel, Carboplatin and Etoposide Vs. 5-Fluorouracil and Folinic Acid in the Treatment of Patients With Adenocarcinoma of Unknown Primary Site
- Compare the overall survival after treatment with paclitaxel, carboplatin, and
etoposide and after treatment with fluorouracil and leucovorin calcium in patients with
adenocarcinoma of unknown primary.
- Compare the response rates, progression free survival, toxicity profile, and quality of
life between the two regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and
presence or absence of liver metastases.
Patients are randomly assigned to one of two treatment arms.
- Arm I: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on
day 1, and oral etoposide on days 1-10. Treatment is repeated every 3 weeks for up to
- Arm II: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV
over 24 hours weekly for 6 weeks. Treatment is repeated every 7 weeks for up to two
Patients are followed every 3 months after treatment for 1 year or until death. Quality of
life questionnaires are completed at each follow-up.
PROJECTED ACCRUAL: Approximately 120-140 patients will be accrued for this study within 3
Allocation: Randomized, Primary Purpose: Treatment
R. L. Jansen, MD, PhD
Academisch Ziekenhuis Maastricht
United States: Federal Government