A Phase I/IIA, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover, Dose Escalation, Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
CPT-11/5-FU/LV is an active combination agent in the treatment of colorectal cancer, but one
of its dose-limiting toxicities is diarrhea. PHY906 has been shown to reduce the severity
of CPT-11–induced toxicity without compromising antitumor efficacy in in vivo animal models.
Additionally, there has been a long historical experience in the Far East demonstrating
safety of PHY906 in humans. Thus, we are conducting this double-blind, placebo-controlled
study to evaluate the safety and tolerability of PHY906. This dose escalation study will
also examine the effect of PHY906 (1.2, 2.4, and 3.6 g/day) on the pharmacokinetics of
CPT-11 and 5-FU after concomitant administration with CPT-11, 5-FU, and LV, and on the
severity of CPT-11–induced toxicities such as diarrhea.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Wayne D Brenckman, Jr., MD
United States: Food and Drug Administration
|Cancer Centers of the Carolinas||Greenville, South Carolina 29605|
|Weill Cornell Medical Center||New York, New York 10021|
|VA CT Cancer Center||West Haven, Connecticut 06516|