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A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors Clinical research trials and A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors. A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors  A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors
A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors
For Condition: Head and Neck Cancer,Prostate Cancer,Colorectal Cancer,Lung Cancer,Breast Cancer
Status: Recruiting
Sponsor(s): Pro-Pharmaceuticals ,
Synopsis: This is a Phase I, multi-center study of a carbohydrate (DAVANAT) which has been shown to increase the anti-tumor activity of 5-fluorouracil in mice. 5-Fluorouracil is a chemotherapy drug commonly used in cancer patients. Patients with different type of solid tumors who have failed standard, approved treatments can be enrolled in the study. Different doses of DAVANAT will be given alone in Cycle 1, and in combination with 5-fluorouracil in cycle 2. Patients will be on study for approximately 90 days. The main reason for doing the study is to determine the safety of the drug given alone and in combination. In patients who have cancer that can be measured by CT scan, it will be determined whether the tumors change in size (get bigger, smaller or stay the same)after Cycle 2.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - The subject is able to give informed consent to participate in this trial (including all procedures and follow-up visits). - The subject is male or female at least 18 years of age. - The subject has a documented histologic or cytologic recurrent or metastatic solid tumor that is not amenable to curative surgery, radiotherapy, or conventional chemotherapy of proven value. - Subjects must have completed previous therapy (chemotherapeutic agents or other therapies including radiation) at least 4 weeks prior to study entry. - Following major surgery (e.g. laparotomy), > 4 weeks must have elapsed and subjects must have recovered from effects. - Following minor surgery (does not include insertion of vascular access device), > 2 weeks must have elapsed. - ECOG performance status of 0-2. - The subject has a life expectancy of at least 12 weeks. - Female subjects must be post-menopausal, surgically sterile, or using effective contraception. Laboratory values prior to administration of study drug: - If female and not post-menopausal, the subject has a negative pregnancy test. - Liver function studies: AST and ALT < 2.5 times the upper limit of normal (ULN); total bilirubin < 1.5 - Hematopoietic parameters: WBC > 3000 per mm3; Granulocyte count > 1,500 per mm3; Platelet count > 100,000 per mm3 - Renal: Creatinine < or = ULN - Pulmonary: Dlco > or = 60% of predicted Exclusion Criteria - If female, the subject is pregnant or breast feeding. - Central nervous system (CNS) metastases or primary CNS tumors. - The subject has a known hypersensitivity to DAVANAT™ or any of its components. - The subject has congestive heart failure or any other medical condition that could be adversely affected by intravenous infusion of up to approximately 200 mL of fluid over 60 minutes. - The subject is currently abusing alcohol and/or illicit drugs. - The subject has other significant medical, psychiatric, or social conditions which, in the investigators’ opinion, may compromise the subject's safety in participating in this study. - In the investigators’ judgment, the subject would be unreliable in adhering to the study visit schedule or other study requirements. - The subject is currently enrolled in a clinical trial or has participated in a clinical trial within the 30 days prior to entry into this study.
Total Enrollment: 40
Location and Contact Information:
Overall Study Official:
MarilynPike, Study Director, Consultant to Pro-Pharmaceuticals, Inc.
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109
United States
Recruiting Mark Zalupski 734-615-3969
Florida Oncology Associates *Recruiting*
Jacksonville, Florida, 32207
United States
Recruiting Gloria Quilon-Perez 904-739-7779
Ochsner Cancer Institute *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carol Marques 504-842-4483
Dartmouth-Hitchcock Medical Center *Recruiting*
Lebanon, New Hampshire, 03756
United States
Recruiting Carol McDonnell 603-650-6380
Additional Information:
Study ID Numbers: DAVFU-001;
Study Start Date: February 2003
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054977
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A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors
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