Carcinoma of Unknown Primary Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells. It is
not yet known which combination chemotherapy regimen is more effective for cancer of unknown
primary origin.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens
of combination chemotherapy in treating patients with cancer of unknown primary origin.
OBJECTIVES:
- 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
four courses.
- 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
courses.
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
years.
;
Allocation: Randomized, Primary Purpose: Treatment
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