An Open Label Prospective Randomised Study Comparing The Use Of Vincristine, Adriamycin And Cyclophosphamide (VAC) Versus Epirubicin, Cisplatin And Continuous 5-Flourouracil (ECF) In Patients With Unknown Primary Carcinoma (UPC)
OBJECTIVES: I. Compare the efficacy of the regimens, in terms of tumor response,
progression-free survival, and overall survival of vincristine, doxorubicin, and
cyclophosphamide vs epirubicin, cisplatin, and fluorouracil in patients with metastatic
carcinoma of unknown primary. II. Compare the toxicity of these regimens in these patients.
III. Compare quality of life and symptom control in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to presence of liver metastases (yes vs no) and type of tumor (adenocarcinoma vs
non-adenocarcinoma). Patients are randomized to one of two treatment arms. Arm I: Patients
receive vincristine IV, doxorubicin IV, and cyclophosphamide IV on day 1. Arm II: Patients
receive epirubicin IV and cisplatin IV over 4 hours on day 1 and fluorouracil IV
continuously on days 1-21. Treatment in both arms repeats every 3 weeks for 3-6 courses in
the absence of disease progression or unacceptable toxicity. Quality of life is assessed at
baseline, at the end of courses 2, 4, and 6, and 1 month after completion of therapy.
Patients are followed at 1 month and then until death.
PROJECTED ACCRUAL: A total of 398 patients (199 per treatment arm) will be accrued for this
Primary Purpose: Treatment
Juan W. Valle, MD
Christie Hospital NHS Foundation Trust
United States: Federal Government