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

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00037180
• Other study ID #: IQ8-01-02-016
• Status: Terminated
• Phase: Phase 2
• First received: May 16, 2002
• Last updated: September 25, 2008
• Start date: April 2002
• Est. completion date: January 2003

Study information

• Verified date: September 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 212
• Est. completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• Celecoxib

• Irinotecan

• 5-fluorouracil

• Leucovorin

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Altoona	Pennsylvania
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Ft. Lauderdale	Florida
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Port St. Lucie	Florida
United States	Pfizer Investigational Site	Puyallup	Washington
United States	Pfizer Investigational Site	St. Joseph	Missouri
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Williamsville	New York
United States	Pfizer Investigational Site	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of NCI CTC grade 2-4 diarrhea during the first cycle (6 weeks) of CPT-11/5-FU/LV chemotherapy
Secondary	Severity of all grades of diarrhea, overall and by cycle
Secondary	Duration of diarrhea, by cycle
Secondary	Diarrhea grade, by day, by cycle
Secondary	Stool count, by day, by cycle
Secondary	Severity of asthenia (fatigue), by week.
Secondary	Asthenia will be assessed with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale.
Secondary	Duration of asthenia, by week, as measured by the FACIT-Fatigue scale
Secondary	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
Secondary	Compliance with celecoxib use Incidence, quantity, and duration of loperamide use
Secondary	Tumor response rate (overall and confirmed)using the World Health Organization [WHO] Response Evaluation Criteria in Solid Tumors [RECIST 2000]
Secondary	Serum tumor marker (carcinoembryonic antigen [CEA]) response rate (as characterized by a 50% reduction from baseline)
Secondary	Time to tumor progression (TTP)
Secondary	Time to treatment failure (TTF)
Secondary	Survival Post-study anticancer treatment
Secondary	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)
Secondary	Inflammatory cytokines which may serve as biomarkers for cancer-related outcomes Beta-glucuronidase as a potential biomarker for tumor response
Secondary	Health resource utilization (collected data to be evaluated separately from this protocol)

External Links

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