Colorectal NeoplasmsPhase 2NCT00051688
Tezacitabine and Oxaliplatin for the Treatment of Patients With Metastatic Colorectal Cancer
A Phase 2 study testing tezacitabine and oxaliplatin in people with Colorectal Neoplasms, run by Chiron Corporation at 8 sites in United States.
Trial summary
The primary purpose of this study is to determine the best dose of tezacitabine when combined with oxaliplatin in patients with metastatic colorectal cancer. This study will also evaluate tumor response to the combination of anti-cancer drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- tezacitabine and oxaliplatin
- How many people
- Not given
- Where
- 8 sitesUnited States
- Study dates
- Jun 2003to Aug 2004
- 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
- Patients with metastatic colorectal adenocarcinoma who have failed one prior course of chemotherapy.
- Patients must have at least one measurable tumor.
- Patients may not have received prior treatment with oxaliplatin.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Kansas City Oncology and Hematology Group
Kansas City, Missouri, 64111
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Comprehensive Cancer Centers of the Desert
Palm Springs, California, 92262
Cancer Institute Medical Group
Santa Monica, California, 90404
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612-9497
ACRC/Arizona Clinical Research Center
Tucson, Arizona, 85712
Georgetown University Medical Center, Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
About this study
The primary purpose of this study is to determine the best dose of tezacitabine when combined with oxaliplatin in patients with metastatic colorectal cancer. This study will also evaluate tumor response to the combination of anti-cancer drugs.
- Conditions
- Colorectal Neoplasms
- Being tested
- tezacitabine, oxaliplatin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tezacitabineDrug
oxaliplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2003 (estimated)
- Study startJun 2003
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Chiron Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051688
- Sponsor's protocol ID
- TEZ101
- Status last verified
- Jul 2006
- First submitted
- 15 Jan 2003
- Last updated
- 11 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tezacitabine and Oxaliplatin for the Treatment of Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00051688
- Acronym / sponsor ID
- TEZ101
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Chiron CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Aug 2004
- First posted
- 16 Jan 2003 (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 primary purpose of this study is to determine the best dose of tezacitabine when combined with oxaliplatin in patients with metastatic colorectal cancer. This study will also evaluate tumor response to the combination of anti-cancer drugs.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| tezacitabine | Drug | – |
| oxaliplatin | 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 11 Jul 2006.
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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.
8 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 tezacitabine and oxaliplatin in people with Colorectal Neoplasms, run by Chiron Corporation at 8 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?
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 11 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
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 11 Jul 2006.