NCT00036517

Brief Summary

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2002

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2002

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

June 24, 2005

Status Verified

September 1, 2004

First QC Date

May 10, 2002

Last Update Submit

June 23, 2005

Conditions

Colorectal NeoplasmsDiarrhea

Keywords

Stage III and Stage IV colorectal cancerdiarrheareducealleviatemodulateSaltz regimenCPT-11irinotecancamptosar5-fluorouracilleucovorin5-FULVchemotherapyside effecttoxicitybotanical drugherbal medicinechinese herbal medicinetraditional chinese medicineTCMoral doseoral administrationconcomitant use

Interventions

PHY906DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must:
  • be between 18 and 75 years of age, inclusive, at the time of enrollment.
  • have advanced colorectal carcinoma, which may be either measurable or non-measurable.
  • not have received either CPT-11, FU, or other cytotoxic chemotherapy agents in any setting (including adjuvant) within 1 year prior to screening.
  • have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • use an effective contraceptive method if the patients are of reproductive potential while enrolled in the study, since the potential effects of the herbs on a developing fetus are unknown.
  • have an estimated life expectancy of at least 20 weeks.
  • provide written informed consent.
  • have adequate organ function as indicated by the following laboratory values; these laboratory values must be obtained within 14 days prior to study enrollment:
  • Bone marrow reserve: absolute granulocyte count (AGC) more than or equal to 1.5 X 10(to the power of 9)/L, platelet count more than or equal to 100 X 10 (to the power of 9)/L, and hemoglobin level more than or equal to 9 g/dL.
  • Hepatic function: serum total bilirubin concentration no greater than 1.5 mg/dL, aspartate transaminase (AST or serum glutamic-oxaloacetic transaminase \[SGOT\]), and alanine transaminase (ALT or serum glutamic-pyruvic transaminase \[SGPT\]) levels no greater than grade 2 toxicity as determined from the NCI-CTC version 2.0.
  • Renal function: serum creatinine level no greater than grade 2 toxicity as determined from the CTC version 2.0.

You may not qualify if:

  • Patients who have or are:
  • Gilbert syndrome (familial, non-hemolytic, acholuric jaundice).
  • patients with enterostomies.
  • untreated brain metastases or deteriorating neurological function after the completion of cranial irradiation.
  • a woman who is currently pregnant and/or breast-feeding.
  • active infections or any serious systemic disorder that, in the opinion of the principal investigator, are incompatible with the study product and/or procedures.
  • used an investigational agent within 4 weeks of study entry.
  • a known hypersensitivity to the study medication, its excipients, its analogs, or any of the component herbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA CT Cancer Center

West Haven, Connecticut, 06516, United States

Location

Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsDiarrhea

Interventions

PHY 906

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wayne D Brenckman, Jr., MD

    Inveresk Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 10, 2002

First Posted

May 13, 2002

Study Start

February 1, 2002

Study Completion

March 1, 2003

Last Updated

June 24, 2005

Record last verified: 2004-09

Locations

US(3)