NCT00001576 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Chang AE, Schneider PD, Sugarbaker PH, Simpson C, Culnane M, Steinberg SM
A prospective randomized trial of regional versus systemic continuous 5-fluorodeoxyuridine chemotherapy in the treatment of colorectal liver metastases. Ann Surg. 1987 Dec;206(6):685-93.
Kemeny N, Conti JA, Cohen A, Campana P, Huang Y, Shi WJ, Botet J, Pulliam S, Bertino JR
Phase II study of hepatic arterial floxuridine, leucovorin, and dexamethasone for unresectable liver metastases from colorectal carcinoma. J Clin Oncol. 1994 Nov;12(11):2288-95.
Kemeny N, Seiter K, Conti JA, Cohen A, Bertino JR, Sigurdson ER, Botet J, Chapman D, Mazumdar M, Budd AJ
Hepatic arterial floxuridine and leucovorin for unresectable liver metastases from colorectal carcinoma. New dose schedules and survival update. Cancer. 1994 Feb 15;73(4):1134-42.

A Phase I Study of Isolated Hepatic Perfusion With Escalating Dose Melphalan Followed by Postoperative Hepatic Arterial Floxuridine and Leucovorin for Metastatic Unresectable Colorectal Cancers of the Liver

Details for clinical trial NCT00001576

Clinical trial NCT00001576 - References