Metastatic Colorectal CancerPhase 2NCT00961571
Sunitinib and Capecitabine for First Line Colon Cancer
A Phase 2 study testing sunitinib and capecitabine in people with Metastatic Colorectal Cancer, run by Georgetown University at 1 site in United States.
Trial summary
This study is for patients with metastatic colorectal cancer who have not been treated with chemotherapy for their cancer. The purpose of this study is to find out if Capecitabine and Sunitinib can be used together to improve progression-free survival in colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- sunitinib and capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Mar 2011
- Phase
- Phase 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, newly diagnosed metastatic colorectal cancer
- Measurable or evaluable disease in which surgical resection with curative intent is not possible
- No adjuvant chemotherapy within 6 months of enrollment
- No prior sunitinib or other receptor tyrosine kinase inhibitors
- 18 years of age or greater
- Anticipated survival of at least 6 months
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- Ambulatory with an ECOG performance status of 0 or 1 and able to maintain weight
- Normal organ and marrow function
- Must agree to avoid pregnancy or fathering a child through out study participation
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- Chemotherapy or radiotherapy within 6 months of enrollment
- Receiving any other investigational agents
- Known untreated brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis
- Not able to ingest oral medications with normal absorption from the GI tract
- Uncontrolled hypertension
- History of severe/unstable angina, heart attack, congestive heart failure, transient ischemic attack, or stroke within 6 months of enrollment
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- Cardiac dysrhythmias
- History of clinically significant bleeding within the past 6 months, including gross hemoptysis or hematuria, or underlying coagulopathy
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study enrollment
- Current treatment with therapeutic doses of coumadin
- Concurrent malignancy other than colorectal cancer
- Known dihydropyrimidine dehydrogenase deficiency
- Uncontrolled intercurrent illness including ongoing or active infection or psychiatric illness that would limit compliance with study requirements.
- Pregnant and nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
Lombardi Cancer Center at Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: A Single-Center, Phase II Trial of Sunitinib and Capecitabine in First Line Treatment of Patients With Metastatic Colorectal Cancer
This study is for patients with metastatic colorectal cancer who have not been treated with chemotherapy for their cancer. The purpose of this study is to find out if Capecitabine and Sunitinib can be used together to improve progression-free survival in colorectal cancer.
All patients will take two medicines (Sunitinib and Capecitabine) by mouth every day until their cancer gets worse.
Read the detailed description
This is a single-center, open-label, one-arm study. Patients will be stratified by prior adjuvant therapy and ECOG performance status at study entry.
In this study, we propose to obtain PET scans at baseline, 2 weeks, 8 weeks and 24 weeks from the initiation of treatment. Response at 2 weeks, 8 weeks and 24 weeks will be correlated to progression-free survival, overall survival and response according to RECIST criteria.
We will collect plasma and urine samples from enrolled patients before and four weeks after sunitinib treatment. The samples will be analyzed and results correlated with patient clinical outcomes in order to explore the underlying mechanism of sunitinib induced hypertension.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- sunitinib and capecitabine
- Keywords
- colorectal cancer, sunitinib, capecitabine
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib and capecitabineDrug
Also called Sunitinib, NSC 736511, Sutent, Capecitabine, Xeloda
Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
| Study group | Role | What they receive |
|---|---|---|
| sunitinib and cepecitabine | Experimental | Administration of sunitinib and capecitabine Receives: Drug: sunitinib and capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Unanticipated side effects and futility
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 Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Aiwu Ruth He, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961571
- Sponsor's protocol ID
- GA61822D
- Other IDs
- 2008-308
- Status last verified
- Feb 2025
- First submitted
- 18 Aug 2009
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Phase II Trial of Sunitinib and Capecitabine in First Line Treatment of Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00961571
- Acronym / sponsor ID
- GA61822D
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- colorectal cancer, sunitinib, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unanticipated side effects and futility
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Aug 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Posted 21 Apr 2017
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 patients with metastatic colorectal cancer who have not been treated with chemotherapy for their cancer. The purpose of this study is to find out if Capecitabine and Sunitinib can be used together to improve progression-free survival in colorectal cancer.
All patients will take two medicines (Sunitinib and Capecitabine) by mouth every day until their cancer gets worse.
Detailed description
This is a single-center, open-label, one-arm study. Patients will be stratified by prior adjuvant therapy and ECOG performance status at study entry.
In this study, we propose to obtain PET scans at baseline, 2 weeks, 8 weeks and 24 weeks from the initiation of treatment. Response at 2 weeks, 8 weeks and 24 weeks will be correlated to progression-free survival, overall survival and response according to RECIST criteria.
We will collect plasma and urine samples from enrolled patients before and four weeks after sunitinib treatment. The samples will be analyzed and results correlated with patient clinical outcomes in order to explore the underlying mechanism of sunitinib induced hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sunitinib and cepecitabine | Experimental | Drug: sunitinib and capecitabineAdministration of sunitinib and capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed, newly diagnosed metastatic colorectal cancer
- Measurable or evaluable disease in which surgical resection with curative intent is not possible
- No adjuvant chemotherapy within 6 months of enrollment
- No prior sunitinib or other receptor tyrosine kinase inhibitors
- 18 years of age or greater
Key exclusion criteria (14 listed)
- Chemotherapy or radiotherapy within 6 months of enrollment
- Receiving any other investigational agents
- Known untreated brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis
- Not able to ingest oral medications with normal absorption from the GI tract
- Uncontrolled hypertension
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 |
|---|---|---|
| sunitinib and capecitabineAlso: Sunitinib, NSC 736511, Sutent, Capecitabine, XelodaSunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily | Drug | sunitinib and cepecitabine |
Primary outcome
Progression-free Survival
Time frame: 36 months
Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Aiwu Ruth He, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sunitinib and capecitabine in people with Metastatic Colorectal Cancer, run by Georgetown University 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 10 inclusion and 14 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 12 Feb 2025. 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 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 21 Apr 2017). 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?
Progression-free Survival (time frame: 36 months). 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 12 Feb 2025.