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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasm Metastasis; Colorectal Neoplasms

Intervention: Celecoxib (Drug); Irinotecan (Drug); 5-fluorouracil (Drug); Leucovorin (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Secondary outcome:

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)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Mobile, Alabama 36685, United States

Pfizer Investigational Site, Ft. Lauderdale, Florida 33308, United States

Pfizer Investigational Site, Port St. Lucie, Florida 34952, United States

Pfizer Investigational Site, Chicago, Illinois 60631, United States

Pfizer Investigational Site, St. Joseph, Missouri 64507, United States

Pfizer Investigational Site, St. Louis, Missouri 63136, United States

Pfizer Investigational Site, Buffalo, New York 14215, United States

Pfizer Investigational Site, Williamsville, New York 14221, United States

Pfizer Investigational Site, Altoona, Pennsylvania 16601, United States

Pfizer Investigational Site, Puyallup, Washington 98372, United States

Pfizer Investigational Site, Yakima, Washington 98902, United States

Pfizer Investigational Site, Milwaukee, Wisconsin 53215, United States

Additional Information

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

Starting date: April 2002
Last updated: September 25, 2008

Page last updated: August 23, 2015

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