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Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors Clinical research trials and Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors. Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors clinical trial. Human subjects often obtain the finest healthcare possible for their Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors  Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors
Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors
For Condition: Solid Tumors
Status: Recruiting
Sponsor(s): Wellstat Therapeutics ,
Synopsis: CPT-11 and 5Fluorouracil (5FU) combined with leucovorin has become the standard of care for colorectal cancer. PN401 permits treatment with higher than normal doses of 5FU, which could increase its therapeutic potential. It is hypothesized that adding PN401 to the CPT-11, 5FU, leucovorin regimen will reduce toxicity and will allow higher doses of 5FU to be well tolerated and therefore potentially increase effectiveness.
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 - Must be at least 18 years of age; - Life expectancy: At least 3 months; - Performance status: ECOG of 0 or 1; - Histologic or cytologic proof of a solid tumor cancer that is not amenable to curative surgical resection; - Evaluable or measurable disease documented within 4 weeks of the start of treatment; - Prior chemotherapy or radiotherapy is allowed if 4 weeks or more have elapsed prior to starting treatment and patients have recovered from toxicities of prior treatment; - Adequate organ function: Hematopoietic: ANC = 1500/ul or more, Platelets = 100,000/ul or more, Hemoglobin = 9.5 g/dL or more, transfusion prior to evaluation is allowed; Hepatic: Bilirubin = 2.0 mg/dL or less and SGPT(ALT) and SGOT(AST) < 3 x upper limit of normal (< 5 x upper limit of normal if liver metastases present) Renal: Serum Creatinine < 2.0 mg/dL; - Patient has the initiative, geographic proximity, and means to be compliant with the protocol; - Fertile patients (male or female) must agree to use effective contraception; - Must be able to swallow and retain tablets. Exclusion Criteria - Major surgery within the four weeks preceding the start of treatment; - Serious medical or psychiatric illness that would prevent self-determined informed consent; - Intensive chemotherapy treatment; - Infection or antibiotics at the time of screening; - Uncontrolled cardiovascular, pulmonary, renal, neurologic, psychiatric, or hepatic dysfunction; - Pregnant or nursing; - Pre-existing diarrhea or uncontrolled clinically significant illness other than cancer (i.e. ulcerative colitis, malabsorption syndrome); - Brain metastases that have not been stable for more than 3 months; - Known Dihydropyrimidine Dehydrogenase (DPD) deficiency.
Total Enrollment: 24
Location and Contact Information:
University of Maryland, Greenebaum Cancer Center *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Shelbey Ainsley 410-328-7558
Additional Information:
Study ID Numbers: 401.02.001; GCC0121
Study Start Date: August 2002
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044785
Other Solid Tumors Studies:
1. Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors
2. Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
3. A Phase 1 Study of S-3304 in Patients with Solid Tumors
Related Studies:
Other Solid Tumors Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors
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