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

Last updated on March 15, 2019

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Study Location
Pfizer Investigational Site
Mobile, Alabama, 36685 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasm Metastasis, Colorectal Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Current enrollment in another clinical trial.

- Prior adjuvant therapy for colorectal cancer

- 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

- Need for concomitant fluconazole or lithium.

- Any known significant bleeding disorder.

- Active inflammatory bowel disease or chronic diarrhea.

NCT00037180
Pfizer
Terminated
For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy

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