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

Last updated on May 12, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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Similar Trials

For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Neoplasm Metastasis
  • Colorectal Neoplasms
  • Drug: Celecoxib
  • Drug: Irinotecan
  • Drug: 5-fluorouracil
  • Drug: Leucovorin
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
212
January 2003
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00037180
IQ8-01-02-016
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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