Colon CancerPhase 1/2NCT00159484
Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer
A Phase 1/2 study testing EPO906 and Celecoxib in people with Colon Cancer and Colorectal Cancer, run by University of Southern California at 1 site in United States.
Trial summary
This study is for people with advanced colorectal cancer. This study uses the drugs Celebrex and EPO906. EPO906 is an experimental drug that has not been approved by the FDA. EPO906 is a drug that has been shown in the laboratory to cause cancer cells to die and prevents them from growing and reproducing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Colorectal Cancer
- What is being tested?
- EPO906 and Celecoxib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2004to 23 Mar 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
Who cannot join
- 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)
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S.C./Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer (CEPO906AUS10)
This study is for people with advanced colorectal cancer. This study uses the drugs Celebrex and EPO906. EPO906 is an experimental drug that has not been approved by the FDA. EPO906 is a drug that has been shown in the laboratory to cause cancer cells to die and prevents them from growing and reproducing. Celebrex is a drug that is approved by the FDA for the treatment of arthritis and prevention of colon polyps. Colon polyps are small growths in the colon. If not surgically removed, some colon polyps can become cancerous. Some studies have shown that Celebrex may reduce the side effects of chemotherapy. Other studies have shown that it may increase the effectiveness of some chemotherapy. Celebrex is not approved by the FDA for reducing the side effects of chemotherapy or improving the effectiveness of chemotherapy. The combination of EPO906 and Celebrex in this study is experimental.
The main goal of this study is to see if adding the drug Celebrex to the drug EPO906 will decrease the amount of diarrhea seen in patients that receive EPO906.
Read more
The goal of the first phase of this study is to find the highest dose of EPO906 that can be given safely with Celebrex. The dose of Celebrex will remain the same for the whole study. Higher doses of EPO906 will be given to each group of patients. The increase of EPO906 will stop once more than one patient has serious side effects. The highest dose of EPO906 that can be given with Celebrex (without serious side effects) will be called the pilot dose.
The goal of the second phase of this study is to find out how tumors respond to these doses of the drugs. Another purpose of this study is to see how the body processes the EPO906 and Celebrex. This study will also look at the side effects of these drugs. In this study, we will measure how long subjects live, how often tumors shrink after receiving the study drugs, and how long it takes for tumors to increase in size after receiving the study drugs. This study will also measure the levels of genes, which are the cell's blueprint, in participant's tumors. Several genes can affect how people's bodies react to the cancer drugs. Genes will also be measured in participant's blood. We want to see if these predict response to the study drugs.
- Conditions
- Colon Cancer, Colorectal Cancer
- Being tested
- EPO906, Celecoxib
- Keywords
- phase 1, phase one, phase I
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPO906Drug
Also called epothilone B, EpoB
EPO906 IV, every three weeks
CelecoxibDrug
Also called Celebrex, Elyxyb, Celebra, Celaxib
celecoxib by mouth twice a day every day
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Dose Level 1 | Experimental | EPO906 7mg in combination with celecoxib Receives: Drug: EPO906; Drug: Celecoxib |
| Phase I, Dose Level II | Experimental | EPO906 8mg in combination with celecoxib Receives: Drug: EPO906; Drug: Celecoxib |
| Phase I, Dose Level Ia | Experimental | EPO906 7mg in combination with celecoxib Receives: Drug: EPO906; Drug: Celecoxib |
| Phase I, Dose Level IIa | Experimental | EPO906 8mg in combination with celecoxib Receives: Drug: EPO906; Drug: Celecoxib |
| Phase I, Dose Level IIIa | Experimental | EPO906 9mg in combination with celecoxib Receives: Drug: EPO906; Drug: Celecoxib |
| Phase I, Dose Level IVa | Experimental | EPO906 10mg in combination with celecoxib Receives: Drug: EPO906; Drug: Celecoxib |
| Phase I, Dose Level Va | Experimental | EPO906 11mg in combination with celecoxib Receives: Drug: EPO906; Drug: Celecoxib |
| Phase I, Dose Level VIa | Experimental | EPO906 12mg in combination with celecoxib Receives: Drug: EPO906; Drug: Celecoxib |
| Phase I, Dose Level VIIa | Experimental | EPO906 13mg in combination with celecoxib Receives: Drug: EPO906; Drug: Celecoxib |
| Phase II, Dose Level Va | Experimental | EPO906 11mg in combination with celecoxib Receives: Drug: EPO906; Drug: Celecoxib |
| Phase II, Dose Level IIIa | Experimental | EPO906 9mg in combination with celecoxib Receives: Drug: EPO906; Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Celebrex in Combination With EPO906
To determine the maximum tolerated dose (MTD) of Celebrex in combination with EPO906 in patients with metastatic colorectal cancer. The MTD is the highest dose that produces the desired therapeutic effect without causing unacceptable or dose-limiting side effects.
Measured: One month
Incidence of Grade 3-4 Diarrhea
Once MTD is established we propose to expand the dose level of the MTD to 62 new patients to evaluate whether the addition of Celebrex to EPO906 can reduce the incidence of grade 3-4 diarrhea to 6% or less.
Measured: Until 30 days after patient receives last study drug, up to 17 months
Secondary outcomes (5)
Overall Survival Rate
To estimate the time to progression, survival and response rate in patients with metastatic colorectal cancer who failed 5-FU/LV, CPT-11 and/or oxaliplatin based hemotherapy and receive Celebrex in combination with EPO906.
Measured: Until Patient goes off study, up to 30 months
Toxicity (DLTs)
To further assess toxicity of this regimen.
Measured: Through study completion, up to 30 months
Molecular Biomarkers in Tumor Tissue Associated With Clinical Outcome for This Regimen.
To investigate whether the molecular biomarkers including protein expression changes from plasma, the expression levels of VEGF, E-cadherin, TP, COX-2, and β-tubulin in tumor tissue associated with clinical outcome for this regimen.
Measured: Until Patient Death
Progression-Free Survival Rate
To estimate the progression-free survival rate in patients with metastatic colorectal cancer who failed 5-FU/LV, CPT-11 and/or oxaliplatin based hemotherapy and receive Celebrex in combination with EPO906.
Measured: Until patient death, up to 30 months
Overall Tumor Response Rate
To estimate the tumor response rate in patients with metastatic colorectal cancer who failed 5-FU/LV, CPT-11 and/or oxaliplatin based hemotherapy and receive Celebrex in combination with EPO906.
Measured: at baseline and every 2 cycles; up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study start12 Oct 2004
- Primary completion13 Jan 2015
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Heinz-Josef Lenz, M.D., Principal investigator, U.S.C/Norris Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159484
- Sponsor's protocol ID
- 3c-03-19
- Status last verified
- Oct 2025
- First submitted
- 8 Sep 2005
- Last updated
- 28 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer (CEPO906AUS10)
- ClinicalTrials.gov ID
- NCT00159484
- Acronym / sponsor ID
- 3c-03-19
- Conditions
- Colon Cancer, Colorectal Cancer
- Keywords
- phase 1, phase one, phase I
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 12 Oct 2004 (actual)
- Primary completion
- 13 Jan 2015 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 28 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for people with advanced colorectal cancer. This study uses the drugs Celebrex and EPO906. EPO906 is an experimental drug that has not been approved by the FDA. EPO906 is a drug that has been shown in the laboratory to cause cancer cells to die and prevents them from growing and reproducing. Celebrex is a drug that is approved by the FDA for the treatment of arthritis and prevention of colon polyps. Colon polyps are small growths in the colon. If not surgically removed, some colon polyps can become cancerous. Some studies have shown that Celebrex may reduce the side effects of chemotherapy. Other studies have shown that it may increase the effectiveness of some chemotherapy. Celebrex is not approved by the FDA for reducing the side effects of chemotherapy or improving the effectiveness of chemotherapy. The combination of EPO906 and Celebrex in this study is experimental.
The main goal of this study is to see if adding the drug Celebrex to the drug EPO906 will decrease the amount of diarrhea seen in patients that receive EPO906.
The goal of the first phase of this study is to find the highest dose of EPO906 that can be given safely with Celebrex. The dose of Celebrex will remain the same for the whole study. Higher doses of EPO906 will be given to each group of patients. The increase of EPO906 will stop once more than one patient has serious side effects. The highest dose of EPO906 that can be given with Celebrex (without serious side effects) will be called the pilot dose.
The goal of the second phase of this study is to find out how tumors respond to these doses of the drugs. Another purpose of this study is to see how the body processes the EPO906 and Celebrex. This study will also look at the side effects of these drugs. In this study, we will measure how long subjects live, how often tumors shrink after receiving the study drugs, and how long it takes for tumors to increase in size after receiving the study drugs. This study will also measure the levels of genes, which are the cell's blueprint, in participant's tumors. Several genes can affect how people's bodies react to the cancer drugs. Genes will also be measured in participant's blood. We want to see if these predict response to the study drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Phase I, Dose Level 1 | Experimental | Drug: EPO906, Drug: CelecoxibEPO906 7mg in combination with celecoxib |
| Phase I, Dose Level II | Experimental | Drug: EPO906, Drug: CelecoxibEPO906 8mg in combination with celecoxib |
| Phase I, Dose Level Ia | Experimental | Drug: EPO906, Drug: CelecoxibEPO906 7mg in combination with celecoxib |
| Phase I, Dose Level IIa | Experimental | Drug: EPO906, Drug: CelecoxibEPO906 8mg in combination with celecoxib |
| Phase I, Dose Level IIIa | Experimental | Drug: EPO906, Drug: CelecoxibEPO906 9mg in combination with celecoxib |
| Phase I, Dose Level IVa | Experimental | Drug: EPO906, Drug: CelecoxibEPO906 10mg in combination with celecoxib |
| Phase I, Dose Level Va | Experimental | Drug: EPO906, Drug: CelecoxibEPO906 11mg in combination with celecoxib |
| Phase I, Dose Level VIa | Experimental | Drug: EPO906, Drug: CelecoxibEPO906 12mg in combination with celecoxib |
| Phase I, Dose Level VIIa | Experimental | Drug: EPO906, Drug: CelecoxibEPO906 13mg in combination with celecoxib |
| Phase II, Dose Level Va | Experimental | Drug: EPO906, Drug: CelecoxibEPO906 11mg in combination with celecoxib |
| Phase II, Dose Level IIIa | Experimental | Drug: EPO906, Drug: CelecoxibEPO906 9mg in combination with celecoxib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
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 |
|---|---|---|
| EPO906Also: epothilone B, EpoBEPO906 IV, every three weeks | Drug | Phase I, Dose Level 1, Phase I, Dose Level II, Phase I, Dose Level IIIa, Phase I, Dose Level IIa, Phase I, Dose Level IVa, Phase I, Dose Level Ia, Phase I, Dose Level VIIa, Phase I, Dose Level VIa, Phase I, Dose Level Va, Phase II, Dose Level IIIa, Phase II, Dose Level Va |
| CelecoxibAlso: Celebrex, Elyxyb, Celebra, Celaxibcelecoxib by mouth twice a day every day | Drug | Phase I, Dose Level 1, Phase I, Dose Level II, Phase I, Dose Level IIIa, Phase I, Dose Level IIa, Phase I, Dose Level IVa, Phase I, Dose Level Ia, Phase I, Dose Level VIIa, Phase I, Dose Level VIa, Phase I, Dose Level Va, Phase II, Dose Level IIIa, Phase II, Dose Level Va |
Primary outcome
Maximum Tolerated Dose (MTD) of Celebrex in Combination With EPO906
Time frame: One month
To determine the maximum tolerated dose (MTD) of Celebrex in combination with EPO906 in patients with metastatic colorectal cancer. The MTD is the highest dose that produces the desired therapeutic effect without causing unacceptable or dose-limiting side effects.
Incidence of Grade 3-4 Diarrhea
Time frame: Until 30 days after patient receives last study drug, up to 17 months
Once MTD is established we propose to expand the dose level of the MTD to 62 new patients to evaluate whether the addition of Celebrex to EPO906 can reduce the incidence of grade 3-4 diarrhea to 6% or less.
5 secondary outcomes
Overall Survival Rate
Time frame: Until Patient goes off study, up to 30 months
Toxicity (DLTs)
Time frame: Through study completion, up to 30 months
Molecular Biomarkers in Tumor Tissue Associated With Clinical Outcome for This Regimen.
Time frame: Until Patient Death
Progression-Free Survival Rate
Time frame: Until patient death, up to 30 months
Overall Tumor Response Rate
Time frame: at baseline and every 2 cycles; up to 30 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Heinz-Josef Lenz, M.D. principal investigator
U.S.C/Norris Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EPO906 and Celecoxib in people with Colon Cancer and Colorectal Cancer, run by University of Southern California at 1 site 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 6 inclusion and 19 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: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 28 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Tolerated Dose (MTD) of Celebrex in Combination With EPO906 (time frame: One month). The study lists 2 primary outcomes in all. 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 28 May 2026.