Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036517
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2002-05-10
Brief Title:
Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
Sponsor:
PhytoCeutica
Organization:
PhytoCeutica
Study Overview
Official Title:
A Phase IIIA Multicenter Double-Blind Randomized Placebo-Controlled Crossover Dose Escalation Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2004-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The triple combination chemotherapy of irinotecan 5-fluorouracil and leucovorin CPT-115-FULV or Saltz regimen is the treatment of choice for patients with advanced colorectal cancer Severe diarrhea unfortunately is a side effect of such treatment Preclinical studies have indicated that the botanical drug PHY906 can reduce such diarrhea without compromising the effectiveness of the chemotherapy The primary purpose of this clinical study is to evaluate the safety tolerability and minimum effective dose of PHY906 when administered in conjunction with the Saltz regimen
Detailed Description:
CPT-115-FULV 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 12 24 and 36 gday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None