Could a common arthritis pill tame Chemo's worst side effect?
NCT ID NCT00159484
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether adding the arthritis drug Celebrex to an experimental chemo drug called EPO906 could reduce severe diarrhea in people with advanced colorectal cancer. The trial enrolled 75 patients who had already tried other treatments. The first phase found the safest dose of EPO906 when combined with Celebrex, and the second phase looked at how well the tumors responded.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Celecoxib (Celebrex) and epothilone B (EPO906)
- What this could lead to
- If successful, this combination could offer a new treatment option for advanced colorectal cancer with fewer severe side effects.
- What could go wrong
- This is an early-phase trial with a small number of participants. The experimental drug EPO906 is not FDA-approved, and the combination may still cause serious side effects or not improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
75 people
The number who actually took part.
- Started
-
Oct 2004
- Finished
-
Mar 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed metastatic adenocarcinoma of the colon or rectum for which no further standard chemotherapy is considered to be effective. Patients must have failed 5-FU, CPT-11 and/or oxaliplatin based chemotherapy. * SWOG performance status 0-1 * ANC\>1000, platelets \>100,000. * Total bilirubin \< 2 x upper limit of normal. Transaminase (AST and/or ALT) \< 2 x upper limit of normal or \< 5 x upper limit of normal in patients with liver metastasis. * Serum creatinine \< 1.25 x institutional upper limit of normal. * Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Exclusion Criteria: * Patient has received any other investigational agent within 28 days of first day of study drug dosing. * History of another malignancy within 3 years prior to study entry, except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ. * Patient has another severe and/or life-threatening medical disease. * Patient has an acute or known chronic liver or kidney disease (e.g., chronic active hepatitis, cirrhosis, chronic renal insufficiency). * Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. * Patient has received chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-C or any antibody therapy) * Patients with symptomatic brain metastasis. * Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (e.g. congestive heart failure, myocardial infarction within 6 months of study) * Medical, social or psychological factors interfering with compliance. * Patients who have undergone major surgery for any cause less than 4 weeks prior to study entry. * Patients taking Coumadin® or other agents containing warfarin, with the exception of low dose Coumadin® (1 mg or less) administered prophylactically for maintenance of in-dwelling lines or ports. * Any peripheral neuropathy \> Grade 1. * Patients with unresolved diarrhea \> Grade 1. * Patients may not have a history of an allergy to sulfonamide drugs. * Patients may not have active peptic ulcer disease or other contraindications to chronic NSAID use or aspirin use. * Patients with lactose intolerance. * Patients taking full-dose NSAIDs, including aspirin, regularly for any reason (e.g., arthritis,history of TIA or myocardial infarction). Patients taking cardiac preventive dose ASA (\<81mg daily) are eligible. Patients should stop taking any other NSAIDs 14 days prior to receiving first dose of Celecoxib. * Patients with hypersensitivity to COX-2 inhibitors, NSAIDS or salycilate. * Patients taking fluconazole or lithium.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
U.S.C./Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
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