Colorectal NeoplasmsPhase 2NCT00040391
A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
A Phase 2 study testing Investigational drug, Irinotecan and 5-fluorouracil in people with Colorectal Neoplasms and Diarrhea, run by Celgene Corporation at 28 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Diarrhea
- What is being tested?
- Investigational drug, Irinotecan and 5-fluorouracil
- How many people
- Not given
- Where
- 28 sitesUnited States
- Study dates
- Jun 2002to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Research Center
Anaheim, California, 92801
Research Center
Burlington, North Carolina, 27216
Research Center
Charleston, South Carolina, 29403
Research Center
Charleston, South Carolina, 29406
Research Center
Concord, California, 94520
Research Center
Dallas, Texas, 75230
Research Center
East Lansing, Michigan, 48824
Research Center
East Setauket, New York, 11733
Research Center
Germantown, Tennessee, 38138
Research Center
Gilroy, California, 95020
Research Center
Greenville, North Carolina, 27834
Research Center
Jacksonville, Florida, 32207
Research Center
Lancaster, Pennsylvania, 17605
Research Center
Las Vegas, Nevada, 89106
Research Center
Little Rock, Arkansas, 72205
Research Center
Los Angeles, California, 90057
Research Center
Madison, Wisconsin, 53792-2454
Research Center
Milwaukee, Wisconsin, 53215
Research Center
Minneapolis, Minnesota, 55455
Research Center
New Orleans, Louisiana, 70115
Research Center
New Port Richey, Florida, 34652
Research Center
Northport, New York, 11768-2364
Research Center
Philadelphia, Pennsylvania, 19140-5189
Research Center
Pittsfield, Massachusetts, 01201
Research Center
Saint Joseph, Michigan, 49085
Research Center
Saint Joseph, Missouri, 64507
Research Center
Scarborough, Maine, 04074-9308
Research Center
Zanesville, Ohio, 43701
About this study
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 Cancer
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.
- Conditions
- Colorectal Neoplasms, Diarrhea
- Being tested
- Investigational drug, Irinotecan, 5-fluorouracil, Leucovorin
- Keywords
- Pharmacia
- Medical subject headings
- Colorectal Neoplasms, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational drugDrug
IrinotecanDrug
5-fluorouracilDrug
LeucovorinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2002 (estimated)
- Study startJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040391
- Sponsor's protocol ID
- 440E-ONC-0020-315
- Status last verified
- Nov 2016
- First submitted
- 26 Jun 2002
- Last updated
- 1 Dec 2016
- Results posted
- No
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. doi: 10.1159/000087302. Epub 2005 Aug 2.
PubMed 16088234
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Cancer
- ClinicalTrials.gov ID
- NCT00040391
- Acronym / sponsor ID
- 440E-ONC-0020-315
- Conditions
- Colorectal Neoplasms, Diarrhea
- Keywords
- Pharmacia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jun 2002
- First posted
- 27 Jun 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational drug | Drug | – |
| Irinotecan | Drug | – |
| 5-fluorouracil | Drug | – |
| Leucovorin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Background: PubMed 16088234Pan 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. doi: 10.1159/000087302. Epub 2005 Aug 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Investigational drug, Irinotecan and 5-fluorouracil in people with Colorectal Neoplasms and Diarrhea, run by Celgene Corporation at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00040391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.