For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00037180

Purpose

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.

Condition	Intervention	Phase
Neoplasm Metastasis Colorectal Neoplasms	Drug: Celecoxib Drug: Irinotecan Drug: 5-fluorouracil Drug: Leucovorin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Phase II, Randomized, Double-Blind, Multicenter Trial Of Celecoxib Vs Placebo For The Prevention Of Diarrhea Associated With CPT-11/5fu/LV Chemotherapy In Patients With Previously Untreated Metastatic Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Diarrhea

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Irinotecan U 101440E Irinotecan hydrochloride Celecoxib Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Incidence of NCI CTC grade 2-4 diarrhea during the first cycle (6 weeks) of CPT-11/5-FU/LV chemotherapy

Secondary Outcome Measures:

Severity of all grades of diarrhea, overall and by cycle
Duration of diarrhea, by cycle
Diarrhea grade, by day, by cycle
Stool count, by day, by cycle
Severity of asthenia (fatigue), by week.
Asthenia will be assessed with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale.
Duration of asthenia, by week, as measured by the FACIT-Fatigue scale
Type, frequency, severity, timing, and relatedness of all adverse events CPT-11/5-FU/LV treatment administration as characterized by median, mean, and range of doses given; dose modifications, omissions, and delays; and actual and relative dose intensity
Compliance with celecoxib use Incidence, quantity, and duration of loperamide use
Tumor response rate (overall and confirmed)using the World Health Organization [WHO] Response Evaluation Criteria in Solid Tumors [RECIST 2000]
Serum tumor marker (carcinoembryonic antigen [CEA]) response rate (as characterized by a 50% reduction from baseline)
Time to tumor progression (TTP)
Time to treatment failure (TTF)
Survival Post-study anticancer treatment
Peak plasma levels and AUC 0-24 values for CPT-11 and its major metabolites, SN-38, SN-38 glucuronide (SN-38G), and aminopentane carboxylic acid (APC)
Inflammatory cytokines which may serve as biomarkers for cancer-related outcomes Beta-glucuronidase as a potential biomarker for tumor response
Health resource utilization (collected data to be evaluated separately from this protocol)

Estimated Enrollment:	212
Study Start Date:	April 2002
Study Completion Date:	January 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037180

Locations

United States, Alabama
Pfizer Investigational Site
Mobile, Alabama, United States, 36685
United States, Florida
Pfizer Investigational Site
Ft. Lauderdale, Florida, United States, 33308
Pfizer Investigational Site
Port St. Lucie, Florida, United States, 34952
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60631
United States, Missouri
Pfizer Investigational Site
St. Joseph, Missouri, United States, 64507
Pfizer Investigational Site
St. Louis, Missouri, United States, 63136
United States, New York
Pfizer Investigational Site
Buffalo, New York, United States, 14215
Pfizer Investigational Site
Williamsville, New York, United States, 14221
United States, Pennsylvania
Pfizer Investigational Site
Altoona, Pennsylvania, United States, 16601
United States, Washington
Pfizer Investigational Site
Puyallup, Washington, United States, 98372
Pfizer Investigational Site
Yakima, Washington, United States, 98902
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00037180 History of Changes
Other Study ID Numbers:	IQ8-01-02-016
Study First Received:	May 16, 2002
Last Updated:	September 25, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Fluorouracil

Irinotecan
Leucovorin
Levoleucovorin
Celecoxib
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on February 12, 2012