Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00036517 |
Recruitment Status :
Terminated
First Posted : May 13, 2002
Last Update Posted : June 24, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Neoplasms Diarrhea | Drug: PHY906 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2002 |
Study Completion Date : | March 2003 |

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
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.
Exclusion Criteria
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036517
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 |
ClinicalTrials.gov Identifier: | NCT00036517 |
Other Study ID Numbers: |
PHY906-2000-1 |
First Posted: | May 13, 2002 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | September 2004 |
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 |
Colorectal Neoplasms Diarrhea Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Signs and Symptoms, Digestive |