|
Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer Clinical research trials and Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer. Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer  Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
For Condition: Diarrhea,Colorectal Neoplasms
Status: Recruiting
Sponsor(s): PhytoCeutica ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
WayneBrenckman, Study Director, Inveresk Research
Weill Cornell Medical Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler 212-746-2844
VA CT Cancer Center *Recruiting*
West Haven, Connecticut, 06516
United States
Recruiting Shivaani Kummar 203-937-3421
Cancer Centers of the Carolinas *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Mark O'Rourke 864-987-7000
Additional Information:
Study ID Numbers: PHY906-2000-1;
Study Start Date: February 2002
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036517
Other Colorectal Neoplasms Studies:
1. Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
2. Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis
3. Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer
4. A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea
5. Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
Related Studies:
Other Colorectal Neoplasms Clinical Trials
Other South Carolina Clinical Trials
Other Greenville Clinical Trials
Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer
|
|
|
|
|
|
|
|
