Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin

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Trial Identification

Brief Title: Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin

Official Title: 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)

Study ID: NCT00022178

Conditions

Carcinoma of Unknown Primary

Interventions

cisplatin

cyclophosphamide

doxorubicin hydrochloride

epirubicin hydrochloride

fluorouracil

vincristine sulfate

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for metastatic cancer of an unknown site of origin. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic cancer of an unknown site of origin.

Detailed Description: 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 study.