Colon CancerPhase 1NCT00183833
Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors
A Phase 1 study testing capecitabine, imatinib mesylate 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 solid tumors cancer for which the standard chemotherapy drugs have not worked. The purpose of this research is to evaluate the side effects of Xeloda (also called capecitabine) in combination with a new anticancer agent called Gleevec (also called imatinib mesylate). 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?
- capecitabine, imatinib mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Aug 2010
- Phase
- Phase 1
- 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
- Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective.
- SWOG performance status 0-2.
- ANC greater than 1500, platelets greater than 100,000.
- Total bilirubin less than 2 x upper limit of normal, or less than 3 x upper limit of normal in patients with liver metastasis. Transaminase (AST and/or ALT) less than 2 x upper limit of normal or less than 3 x upper limit of normal in patients with liver metastasis.
- Serum creatinine less than 1.25 x institutional upper limit of normal.
- Female patients of childbearing 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.
- Patient with another primary malignancy except if the other primary malignancy is neither currently clinically significant nor requiring active intervention.
- Patient has another severe and/or life-threatening medical disease.
- Patient has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis).
- 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) prior to study entry unless urgent enrollment needed and approved by Novartis.
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- Patient had a major surgery within 2 weeks prior to study entry.
- 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 under therapeutic coumadin therapy.
- Patients under routine systemic corticosteroid therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Cancer Center
Los Angeles, California, 90033
About this study
Official title: Phase I/II Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors
This study is for people with solid tumors cancer for which the standard chemotherapy drugs have not worked. The purpose of this research is to evaluate the side effects of Xeloda (also called capecitabine) in combination with a new anticancer agent called Gleevec (also called imatinib mesylate). Xeloda is an anticancer drug, and can be taken by mouth. The active ingredient is a well-studied cancer drug called 5-FU. Xeloda is approved by the FDA for the treatment of colon cancer. Gleevec is approved in the US for the treatment of patients with a leukemia called CML (increase of white blood cells) after failure of standard therapy. It is also approved by the FDA for patients with Gastrointestinal Stromal Tumors (a rare tumor in the digestive tract).
This study will test how much Gleevec we can safely give with Xeloda. Xeloda will be given at the recommended dose for colorectal cancer and Gleevec will be given in increasing amounts.
- Conditions
- Colon Cancer, Colorectal Cancer
- Being tested
- capecitabine, imatinib mesylate
- Keywords
- phase 1, phase I, phase one, colon cancer, colorectal cancer
- 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.
capecitabine, imatinib mesylateDrug
Capecitabine and imatinib mesylate will both be taken by mouth twice a day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Xeloda plus gleevec Receives: Drug: capecitabine, imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of Gleevec in combination with a fixed dose of Xeloda po bid daily in patients with colon cancer.
Measured: 4 weeks
Secondary outcomes (3)
To determine the time to progression, survival and response rate.
Measured: Until Patient goes off study
To obtain preliminary data on molecular correlates to determine clinical efficacy
Measured: Until Patient Goes off study
Toxicity.
Measured: 30 days after patient receives last drug dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2002
- Primary completionJul 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT00183833
- Sponsor's protocol ID
- 3C-02-1
- Status last verified
- May 2014
- First submitted
- 9 Sep 2005
- Last updated
- 22 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00183833
- Acronym / sponsor ID
- 3C-02-1
- Conditions
- Colon Cancer, Colorectal Cancer
- Keywords
- phase 1, phase I, phase one, colon cancer, colorectal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Dec 2002
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 16 Sep 2005 (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.
This study is for people with solid tumors cancer for which the standard chemotherapy drugs have not worked. The purpose of this research is to evaluate the side effects of Xeloda (also called capecitabine) in combination with a new anticancer agent called Gleevec (also called imatinib mesylate). Xeloda is an anticancer drug, and can be taken by mouth. The active ingredient is a well-studied cancer drug called 5-FU. Xeloda is approved by the FDA for the treatment of colon cancer. Gleevec is approved in the US for the treatment of patients with a leukemia called CML (increase of white blood cells) after failure of standard therapy. It is also approved by the FDA for patients with Gastrointestinal Stromal Tumors (a rare tumor in the digestive tract).
This study will test how much Gleevec we can safely give with Xeloda. Xeloda will be given at the recommended dose for colorectal cancer and Gleevec will be given in increasing amounts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: capecitabine, imatinib mesylateXeloda plus gleevec |
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 or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective.
- SWOG performance status 0-2.
- ANC greater than 1500, platelets greater than 100,000.
- Total bilirubin less than 2 x upper limit of normal, or less than 3 x upper limit of normal in patients with liver metastasis. Transaminase (AST and/or ALT) less than 2 x upper limit of normal or less than 3 x upper limit of normal in patients with liver metastasis.
- Serum creatinine less than 1.25 x institutional upper limit of normal.
Key exclusion criteria (12 listed)
- Patient has received any other investigational agent- within 28 days of first day of study drug dosing.
- Patient with another primary malignancy except if the other primary malignancy is neither currently clinically significant nor requiring active intervention.
- Patient has another severe and/or life-threatening medical disease.
- Patient has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis).
- 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 |
|---|---|---|
| capecitabine, imatinib mesylateCapecitabine and imatinib mesylate will both be taken by mouth twice a day | Drug | A |
Primary outcome
To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of Gleevec in combination with a fixed dose of Xeloda po bid daily in patients with colon cancer.
Time frame: 4 weeks
3 secondary outcomes
To determine the time to progression, survival and response rate.
Time frame: Until Patient goes off study
To obtain preliminary data on molecular correlates to determine clinical efficacy
Time frame: Until Patient Goes off study
Toxicity.
Time frame: 30 days after patient receives last drug dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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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 study testing capecitabine, imatinib mesylate 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 12 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 22 May 2014. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of Gleevec in combination with a fixed dose of Xeloda po bid daily in patients with colon cancer. (time frame: 4 weeks). 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 22 May 2014.