Scarborough, Maine 04074

  • Diarrhea

Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

440E-ONC-0020-315


NCT ID:

NCT00040391


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Celgene Corporation


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Start Date:June 2002
Verification Date:November 2016
Last Changed Date:November 30, 2016
First Received Date:June 26, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Investigational drug
Intervention Type:Drug
Name:Irinotecan
Intervention Type:Drug
Name:5-fluorouracil
Intervention Type:Drug
Name:Leucovorin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Celgene Corporation
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:16088234

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


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