A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer

NCT00040391

Last updated date
Study Location
Research Center
Little Rock, Arkansas, 72205, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Neoplasms, Diarrhea
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

- Age 18 years or older

- Diagnosis of colorectal cancer or adenocarcinoma of the appendix

- A tumor mass that can be measured

- Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC grade less than or equal to 1

- Willingness and ability to comply with scheduled visits, treatment plan, and laboratory tests, and other study procedures

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Women that are pregnant or lactating


- Prior treatment with Irinotecan


- Partial or complete bowel obstruction, known chronic malabsorption, or total colectomy
or other major abdominal surgery that might result in substantial alteration in
transit or absorption of oral medication


- Administration of the last dose of any previous adjuvant therapy for colorectal cancer
within 6 months previous to randomization


- Current enrollment in another clinical trial


- Administration of any prior systemic anticancer therapy for metastatic colorectal
cancer

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Colorectal Neoplasms, DiarrheaA Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
NCT00040391
  1. Little Rock, Arkansas
  2. Anaheim, California
  3. Concord, California
  4. Gilroy, California
  5. Los Angeles, California
  6. Jacksonville, Florida
  7. New Port Richey, Florida
  8. New Orleans, Louisiana
  9. Scarborough, Maine
  10. Pittsfield, Massachusetts
  11. East Lansing, Michigan
  12. St. Joseph, Michigan
  13. Minneapolis, Minnesota
  14. St. Joseph, Missouri
  15. Las Vegas, Nevada
  16. East Setauket, New York
  17. Northport, New York
  18. Burlington, North Carolina
  19. Greenville, North Carolina
  20. Zanesville, Ohio
  21. Lancaster, Pennsylvania
  22. Philadelphia, Pennsylvania
  23. Charleston, South Carolina
  24. Charleston, South Carolina
  25. Germantown, Tennessee
  26. Dallas, Texas
  27. Madison, Wisconsin
  28. Milwaukee, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
Official Title  ICMJE A Phase II, Randomized, Open-label, Controlled, Dose-elevation, Multicenter Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer
Brief Summary The study will combine a new investigational drug with standard anti-cancer drugs for the treatment of advanced colorectal cancer. The standard and approved treatment for colorectal cancer is to undergo chemotherapy with a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as 5-FU), and leucovorin (also known as LV). This is known as the triple therapy. One of the major side effects of CPT-11/5-FU/LV chemotherapy treatment is diarrhea. The purpose of this research study is to see whether adding this investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. This study will also determine if adding the investigational drug to triple therapy has a positive effect on tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Neoplasms
  • Diarrhea
Intervention  ICMJE
  • Drug: Investigational drug
  • Drug: Irinotecan
  • Drug: 5-fluorouracil
  • Drug: Leucovorin
Study Arms  ICMJE Not Provided
Publications * Pan CX, Loehrer P, Seitz D, Helft P, Juliar B, Ansari R, Pletcher W, Vinson J, Cheng L, Sweeney C. A phase II trial of irinotecan, 5-fluorouracil and leucovorin combined with celecoxib and glutamine as first-line therapy for advanced colorectal cancer. Oncology. 2005;69(1):63-70. Epub 2005 Aug 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of colorectal cancer or adenocarcinoma of the appendix
  • A tumor mass that can be measured
  • Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC grade less than or equal to 1
  • Willingness and ability to comply with scheduled visits, treatment plan, and laboratory tests, and other study procedures

Exclusion Criteria:

  • Women that are pregnant or lactating
  • Prior treatment with Irinotecan
  • Partial or complete bowel obstruction, known chronic malabsorption, or total colectomy or other major abdominal surgery that might result in substantial alteration in transit or absorption of oral medication
  • Administration of the last dose of any previous adjuvant therapy for colorectal cancer within 6 months previous to randomization
  • Current enrollment in another clinical trial
  • Administration of any prior systemic anticancer therapy for metastatic colorectal cancer
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00040391
Other Study ID Numbers  ICMJE 440E-ONC-0020-315
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene Corporation
Study Sponsor  ICMJE Celgene Corporation
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Celgene Corporation
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP