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Sponsors and Collaborators: |
Yale University PhytoCeutica |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00730158 |
PHY906 is an oral form of a spray dried aqueous extract composed of four main herbs, which have been used in the Orient for nearly 2000 years for a variety of GI symptoms including diarrhea and nausea/vomiting. Extensive pre-clinical research has been done with Chinese herbal medicine, and studies have documented significant anticancer activity in combination with various cytotoxic agents including CPT-11, which is a semi-synthetic derivative of the natural alkaloid camptothecin and belongs to the class of topoisomerase I inhibitors. The proposed plan will investigate the mechanism and efficacy of Chinese herbal medicine as an adjunct to chemotherapy in treatment of patients with metastatic colorectal cancer. Our rationale for the therapeutic use of PHY906 is its potential activity in reducing chemotherapy-induced toxicity, especially diarrhea.
Condition | Intervention | Phase |
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Colorectal Neoplasms |
Drug: PHY906 Drug: CPT-11 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase IB/II Multi-Center Clinical Study of PHY906 as a Modulator of CPT-11 Chemotherapy in Patients With Metastatic Colorectal Cancer |
Estimated Enrollment: | 54 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
ANC count ≥ 1,500/ mm3. Platelets ≥ 100,000/ mm3. Serum creatinine ≤ 2x upper limit of normal. Total bilirubin < 1.5x upper limit of normal. Serum calcium < 12.0 mg/dl. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x the upper limit of normal (≤ 5.0 x ULN is acceptable if liver has tumor involvement) Prothrombin Time (PT), activated partial thromboplastin time (aPTT) and INR ≤ 1.5 x ULN or in the therapeutic range if on anticoagulation Hemoglobin ≥ 9 gm/dl (may be corrected by transfusion).
Exclusion Criteria:
United States, Connecticut | |
Yale University Comprehensive Cancer Center | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Contact: Lois Ravage-Mass, RN 203-785-4991 lois.ravage-mass@yale.edu | |
Contact: Lynne Lamb, R.N. 203-737-2562 lynne.lamb@yale.edu | |
Principal Investigator: Wasif Saif, MD | |
VACT Cancer Center | Not yet recruiting |
West Haven, Connecticut, United States, 06516 | |
Contact: Michal Rose, M.D. 203-937-3421 |
Principal Investigator: | Wasif Saif, MD | Yale University Comprehensive Cancer Center |
Responsible Party: | Yale University School of Medicine ( Wasif Saif, M.D., Principal Investigator ) |
Study ID Numbers: | 0706002781, ACS IRG 58-012-49 |
Study First Received: | August 4, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00730158 |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |