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

NCT ID: NCT00037180

Last Updated: 2008-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2003-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasm Metastasis Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Celecoxib

Intervention Type DRUG

Irinotecan

Intervention Type DRUG

5-fluorouracil

Intervention Type DRUG

Leucovorin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Mobile, Alabama, United States

Site Status

Pfizer Investigational Site

Fort Lauderdale, Florida, United States

Site Status

Pfizer Investigational Site

Port Saint Lucie, Florida, United States

Site Status

Pfizer Investigational Site

Chicago, Illinois, United States

Site Status

Pfizer Investigational Site

Saint Joseph, Missouri, United States

Site Status

Pfizer Investigational Site

St Louis, Missouri, United States

Site Status

Pfizer Investigational Site

Buffalo, New York, United States

Site Status

Pfizer Investigational Site

Williamsville, New York, United States

Site Status

Pfizer Investigational Site

Altoona, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Puyallup, Washington, United States

Site Status

Pfizer Investigational Site

Yakima, Washington, United States

Site Status

Pfizer Investigational Site

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=IQ8-01-02-016&StudyName=For+Prevention+of+Diarrhea+in+Patients+Diagnosed+With+Metastatic+Colorectal+Cancer+Treated+With+Chemotherapy

To obtain contact information for a study center near you, click here.

Other Identifiers

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IQ8-01-02-016

Identifier Type: -

Identifier Source: org_study_id