Neoplasm MetastasisPhase 2NCT00037180
For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy
A Phase 2 study testing Celecoxib, Irinotecan and 5-fluorouracil in people with Neoplasm Metastasis and Colorectal Neoplasms, run by Pfizer at 12 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis, Colorectal Neoplasms
- What is being tested?
- Celecoxib, Irinotecan and 5-fluorouracil
- How many people
- 212 participants
- Where
- 12 sitesUnited States
- Study dates
- Apr 2002to Jan 2003
- 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Pfizer Investigational Site
Altoona, Pennsylvania, 16601
Pfizer Investigational Site
Buffalo, New York, 14215
Pfizer Investigational Site
Chicago, Illinois, 60631
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308
Pfizer Investigational Site
Milwaukee, Wisconsin, 53215
Pfizer Investigational Site
Mobile, Alabama, 36685
Pfizer Investigational Site
Port Saint Lucie, Florida, 34952
Pfizer Investigational Site
Puyallup, Washington, 98372
Pfizer Investigational Site
Saint Joseph, Missouri, 64507
Pfizer Investigational Site
St Louis, Missouri, 63136
Pfizer Investigational Site
Williamsville, New York, 14221
Pfizer Investigational Site
Yakima, Washington, 98902
About this study
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
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.
- Conditions
- Neoplasm Metastasis, Colorectal Neoplasms
- Being tested
- Celecoxib, Irinotecan, 5-fluorouracil, Leucovorin
- Medical subject headings
- Neoplasm Metastasis, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
IrinotecanDrug
5-fluorouracilDrug
LeucovorinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of NCI CTC grade 2-4 diarrhea during the first cycle (6 weeks) of CPT-11/5-FU/LV chemotherapy
Secondary outcomes (17)
Severity of all grades of diarrhea, overall and by cycle
Duration of diarrhea, by cycle
Diarrhea grade, by day, by cycle
Stool count, by day, by cycle
Severity of asthenia (fatigue), by week.
Asthenia will be assessed with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale.
Duration of asthenia, by week, as measured by the FACIT-Fatigue scale
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
Compliance with celecoxib use Incidence, quantity, and duration of loperamide use
Tumor response rate (overall and confirmed)using the World Health Organization [WHO] Response Evaluation Criteria in Solid Tumors [RECIST 2000]
Serum tumor marker (carcinoembryonic antigen [CEA]) response rate (as characterized by a 50% reduction from baseline)
Time to tumor progression (TTP)
Time to treatment failure (TTF)
Survival Post-study anticancer treatment
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)
Inflammatory cytokines which may serve as biomarkers for cancer-related outcomes Beta-glucuronidase as a potential biomarker for tumor response
Health resource utilization (collected data to be evaluated separately from this protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2002 (estimated)
- Study startApr 2002
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 212 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037180
- Sponsor's protocol ID
- IQ8-01-02-016
- Status last verified
- Sep 2008
- First submitted
- 16 May 2002
- Last updated
- 29 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00037180
- Acronym / sponsor ID
- IQ8-01-02-016
- Conditions
- Neoplasm Metastasis, Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 212 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- Jan 2003 (actual)
- First posted
- 17 May 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Celecoxib | Drug | – |
| Irinotecan | Drug | – |
| 5-fluorouracil | Drug | – |
| Leucovorin | Drug | – |
Primary outcome
Incidence of NCI CTC grade 2-4 diarrhea during the first cycle (6 weeks) of CPT-11/5-FU/LV chemotherapy
17 secondary outcomes
Severity of all grades of diarrhea, overall and by cycle
Duration of diarrhea, by cycle
Diarrhea grade, by day, by cycle
Stool count, by day, by cycle
Severity of asthenia (fatigue), by week.
Asthenia will be assessed with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale.
Duration of asthenia, by week, as measured by the FACIT-Fatigue scale
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
Compliance with celecoxib use Incidence, quantity, and duration of loperamide use
Tumor response rate (overall and confirmed)using the World Health Organization [WHO] Response Evaluation Criteria in Solid Tumors [RECIST 2000]
Serum tumor marker (carcinoembryonic antigen [CEA]) response rate (as characterized by a 50% reduction from baseline)
Time to tumor progression (TTP)
Time to treatment failure (TTF)
Survival Post-study anticancer treatment
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)
Inflammatory cytokines which may serve as biomarkers for cancer-related outcomes Beta-glucuronidase as a potential biomarker for tumor response
Health resource utilization (collected data to be evaluated separately from this protocol)
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 29 Sep 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
12 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 Celecoxib, Irinotecan and 5-fluorouracil in people with Neoplasm Metastasis and Colorectal Neoplasms, run by Pfizer at 12 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 7 inclusion and 11 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 29 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
What does the primary outcome measure?
Incidence of NCI CTC grade 2-4 diarrhea during the first cycle (6 weeks) of CPT-11/5-FU/LV chemotherapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2008.