For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy

Stopped early · Phase 2

Conditions studied: Neoplasm Metastasis, Colorectal Neoplasms

In brief

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.

Key facts

Study ID

NCT00037180

Run by

Pfizer

People needed

212

Starts

2002-04-01

Expected to finish

2003-01-01

Last updated by the study team

2008-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Mobile, Alabama, United States
• Pfizer Investigational Site — Fort Lauderdale, Florida, United States
• Pfizer Investigational Site — Port Saint Lucie, Florida, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Saint Joseph, Missouri, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — Buffalo, New York, United States
• Pfizer Investigational Site — Williamsville, New York, United States
• Pfizer Investigational Site — Altoona, Pennsylvania, United States
• Pfizer Investigational Site — Puyallup, Washington, United States
• Pfizer Investigational Site — Yakima, Washington, United States
• Pfizer Investigational Site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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