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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. Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer
2. A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies
3. Safety Study of 90Y-hMN14 to Treat Colorectal Cancer
4. An Open Label Study of a Peptide Vaccine in Patients with Stage III Colon Cancer
5. Tezacitabine and oxaliplatin for the treatment of patients with metastatic colorectal cancer
Related Studies:
Other Colorectal Neoplasms Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Investigational Drug in Patients with Metastatic Colorectal Cancer who Failed Treatment with a 5-FU/Leucovorin Regimen
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