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Home > "F" Clinical Trials Conditions > For Prevention of Diarrhea in Patients Diagnosed with Metastatic Colorectal Cancer Treated with Chemotherapy  For Prevention of Diarrhea in Patients Diagnosed with Metastatic Colorectal Cancer Treated with Chemotherapy
For Prevention of Diarrhea in Patients Diagnosed with Metastatic Colorectal Cancer Treated with Chemotherapy
For Condition: Neoplasm Metastasis,Colorectal Neoplasms
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: The Diarrhea Prevention with an investigational drug trial, will evaluate whether adding an investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. The standard and approved treatment for patients with metastatic colorectal cancer is repeated cycles of chemotherapy consisting of a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as 5FU), and leucovorin (also known as LV). Preclinical data from animal models suggest that the investigational drug may offer an effective means for preventing CPT-11/5FU/LV-induced diarrhea. It is also hypothesized that the investigational drug-mediated anti-angiogenesis could induce a favorable tumor response.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria: Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease and present or past histological documentation of adenocarcinoma of the colon or rectum. Tumor must be measureable. Resolution of all acute toxic effects of any prior radiotherapy or surgical procedure. ECOG performance status 0 or 1. Age >= 18 years. Required baseline laboratory. Negative pregnancy test. Willingness and ability to comply with the treatment plan. Exclusion Criteria: Current enrollment in another clinical trial. Prior adjuvant therapy for colorectal cancer <= 6 months prior to randomization. Prior systemic anticancer therapy or intra-arterial cytotoxic chemotherapy given as treatment for metastatic colorectal cancer. Known allergy to CPT-11, 5-FU, LV, celecoxib, other COX-2 inhibitors, non-steroidal anti-inflammatory drugs (NSAIDS), salicylates, or sulfonamides. Chronic concomitant use of full-dose aspirin, other NSAIDs or other COX-2 inhibitors for a chronic nonmalignant condition. A requirement for chronic concomitant use of low-dose (cardioprotective) aspirin. Chronic oral steroid use for treatment of a non-malignant condition. Known ulceration of the gastric or duodenal mucosa <= 30 days prior to randomization. Need for concomitant fluconazole or lithium. Any known significant bleeding disorder. Active inflammatory bowel disease or chronic diarrhea.
Total Enrollment:
Location and Contact Information:
Research Center
Zanesville, Ohio, 43701
United States
Research Center
Port St. Lucie, Florida, 34952
United States
Research Center
St. Joseph, Missouri, 64507
United States
Research Center
Buffalo, New York, 14215
United States
Research Center
Lancaster, Pennsylvania, 17605
United States
Research Center
St. Louis, Missouri, 63136
United States
Research Center
Puyallup, Washington, 98372
United States
Research Center
Milwaukee, Wisconsin, 53215
United States
Research Center
Williamsville, New York, 14221
United States
Research Center
Mobile, Alabama, 36608
United States
Research Center
Kingston, Pennsylvania, 18704
United States
Research Center
Des Moines, Iowa, 50314
United States
Research Center
Morristown, New Jersey, 07962
United States
Research Center
Tyler, Texas, 75701
United States
Research Center
Altoona, Pennsylvania, 16601
United States
Research Center
Yakima, Washington, 98902
United States
Research Center
Valhalla, New York, 10595
United States
Research Center
Ft. Lauderdale, Florida, 03308
United States
Research Center
Los Angeles, California, 90057
United States
Research Center
Chicago, Illinois, 60631
United States
Additional Information:
Study ID Numbers: IQ8-01-02-016;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037180
Other Colorectal Neoplasms Studies:
1. 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
2. Safety and Efficacy of Targeted Gene Transfer in Colorectal Cancer Metastatic to Liver
3. A phase II, randomized, open-label, controlled, dose-elevation, multicenter trial of an investigational drug for the prevention of diarrhea associated with Irinotecan/5FU/Leucovorin chemotherapy in patients with previously untreated metastatic colorectal cancer
4. An Open Label Study of a Peptide Vaccine in Patients with Stage III Colon 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 Missouri Clinical Trials
Other St. Louis Clinical Trials
For Prevention of Diarrhea in Patients Diagnosed with Metastatic Colorectal Cancer Treated with Chemotherapy
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