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Sponsored by: |
PhytoCeutica |
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Information provided by: | PhytoCeutica |
ClinicalTrials.gov Identifier: | NCT00036517 |
The triple combination chemotherapy of irinotecan, 5-fluorouracil and leucovorin (CPT-11/5-FU/LV 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.
Condition | Intervention | Phase |
---|---|---|
Colorectal Neoplasms Diarrhea |
Drug: PHY906 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 30 |
Study Start Date: | February 2002 |
Estimated Study Completion Date: | March 2003 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must:
Exclusion Criteria
Patients who have or are:
United States, Connecticut | |
VA CT Cancer Center | |
West Haven, Connecticut, United States, 06516 | |
United States, New York | |
Weill Cornell Medical Center | |
New York, New York, United States, 10021 | |
United States, South Carolina | |
Cancer Centers of the Carolinas | |
Greenville, South Carolina, United States, 29615 |
Study Director: | Wayne D Brenckman, Jr., MD | Inveresk Research |
Study ID Numbers: | PHY906-2000-1 |
Study First Received: | May 10, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00036517 |
Health Authority: | United States: Food and Drug Administration |
Stage III and Stage IV colorectal cancer diarrhea reduce alleviate modulate Saltz regimen CPT-11 irinotecan camptosar 5-fluorouracil leucovorin 5-FU |
LV chemotherapy side effect toxicity botanical drug herbal medicine chinese herbal medicine traditional chinese medicine TCM oral dose oral administration concomitant use |
Diarrhea Digestive System Neoplasms Signs and Symptoms, Digestive Gastrointestinal Diseases Irinotecan Colonic Diseases Leucovorin Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Signs and Symptoms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site |