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Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen Clinical research trials and Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen. Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen clinical trial. Participants frequently get the best healthcare available for their Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen  Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen
Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen
For Condition: Colorectal Neoplasms
Status: Recruiting
Sponsor(s): Pfizer ,
Synopsis: The purpose of this study is to determine the response rate in patients with metastatic colorectal cancer who failed treatment with a 5-Fluorouracil/Leucovorin (5-FU/LV) regimen and up to one other chemotherapeutic regimen (not including adjuvant chemotherapy).
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: - Presence of measurable, metastatic (Stage IV or recurrent) adenocarcinoma of the colon or rectum (histologically or cytologically confirmed at the time of original diagnosis) - Disease recurrence or progression during or after completion of first-line chemotherapy with a 5-FU/LV regimen. Patients may have received irinotecan or oxaliplatin as part of the 5-FU/LV regimen or as subsequent therapy. - Patients may have received up to two prior regimens for metastatic disease. In addition, they may have received one additional regimen as adjuvant therapy if they remained disease-free for more than 6 months after completion of that adjuvant regimen. If evidence of failure occurred within less than 6 months of completion of adjuvant therapy, then the patient will be permitted to have received that adjuvant regimen plus only one additional regimen for metastatic disease prior to study entry. The newer, targeted, investigational agents such as cetuximab (Erbitux™) and bevacizumab (Avastin™) are not counted as a chemotherapeutic regimen unless used in combination with cytotoxic agents. - Capable of understanding the nature of the trial and willing to give written informed consent - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 - Hemoglobin level of greater than or equal to 9 g/dL, absolute granulocyte count of greater than or equal to 1.5 × 109/L, and platelet count of greater than or equal to 100 × 109/L - Adequate renal function, as documented by a serum creatinine level of less than or equal to 1.5 mg/dL and a measured or calculated creatinine clearance of greater than or equal to 60 mL/min - Adequate liver function, as demonstrated by a total bilirubin level of less than or equal to 1.5 mg/dL (unless patient has Gilbert’s syndrome, then less than or equal to 3.0 mg/dL); levels of serum glutamate oxaloacetic transaminase (SGOT) (alanine transaminase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine transaminase [ALT]) less than or equal to 2 times the institutional upper limit of normal (ULN). If the patient has liver involvement then AST or ALT should be less than or equal to 5 times ULN. - For men with partners of child-bearing potential and all women of childbearing potential, willingness to use adequate contraception or practice abstinence during the course of the study (men with sterile partners or sterile women will be considered as practicing adequate birth control) - At least 18 years of age - Life expectancy estimated at greater than 12 weeks
Total Enrollment: 56
Location and Contact Information:
Pfizer Investigational Site *Recruiting*
Tampa, Florida, 33612
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Poway, California, 92064
United States
Recruiting
Additional Information:
Study ID Numbers: A4371004;
Study Start Date: January 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078468
Other Colorectal Neoplasms Studies:
1. Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients with Limited Residual Disease After Surgery
2. Tezacitabine and oxaliplatin for the treatment of patients with metastatic colorectal cancer
3. Safety and Efficacy of Targeted Gene Transfer in Colorectal Cancer Metastatic to Liver
4. A Phase II Study of 5-Fluorouracil Administered as a One Hour Infusion in Combination with Calcium Leucovorin and Interferon Alpha-2A in Advanced Colorectal Cancer
5. Treatment of patients with previously treated metastatic colorectal cancer with oxaliplatin/5FU/LV and PTK787 or placebo
Related Studies:
Other Colorectal Neoplasms Clinical Trials
Other California Clinical Trials
Other Poway Clinical Trials
Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen
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