Metastatic Colorectal CancerPhase 2NCT00954876
Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Colorectal Cancer
A Phase 2 study testing capecitabine and cetuximab in people with Metastatic Colorectal Cancer, run by Translational Genomics Research Institute at 1 site in United States.
Trial summary
The combination of capecitabine and cetuximab as first-line therapy will result in improved progression free survival compared to single agent capecitabine in patients with KRAS wild type 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?
- capecitabine and cetuximab
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jan 2010
- 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
Who may be able to join
- Metastatic colorectal cancer
- Tumor classified WT KRAS
- At least 18 yrs of age
- ECOG PS 0,1 or 2
- Evidence of adequate organ function
- Measurable disease per RECIST criteria
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- Have at least two of the following criteria:
- Age > 65 years
- ECOG PS 1 or 2
- Serum Albumin < or equal to 3.5g/dL
- Prior RT to abdomen or pelvis
- Stopped first-line combination systemic chemotherapy < 6 weeks duration
Who cannot join
- Tumors classified as KRAS mutation
- Prior therapy with cetuximab, panitumumab or other agent that targets EGFR
- Prior exposure to any biologic
- Known sensitivity to cetuximab or 5-FU (or marked intolerance to 5-FU)
- Known DPD deficiency
- Uncontrolled angina or a myocardial infarction within the previous 12 months
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- Concurrent severe uncontrolled medical illness
- Known uncontrolled CNS metastases
- Bowel disease associated with chronic diarrhea
- Major surgery within 28 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Evergreen Hematology & Oncology
Spokane, Washington, 99218
About this study
Official title: Phase II, Multi-Center, Open-Label, Prospective Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type KRAS Colorectal Cancer Who Are Considered Nonoptimal Candidates or Are Intolerant to a First-Line Oxaliplatin/Irinotecan Regimen
The combination of capecitabine and cetuximab as first-line therapy will result in improved progression free survival compared to single agent capecitabine in patients with KRAS wild type colorectal cancer. Patients who are not able or willing to take Oxaliplatin/Irinotecan combination therapy are eligible for this study.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- capecitabine and cetuximab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine and cetuximabDrug
Cetuximab 500 mg/m2 IV infusion over 1-2 hours Once every 2 weeks
Capecitabine 1500 mg/m2 PO BID Days 1-7 followed by 7 days of no treatment and repeated every 2 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab
Measured: 18 months
Secondary outcomes (4)
To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
Measured: 18 months
To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
Measured: 18 months
To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population
Measured: every three months
To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy.
Measured: 1 year after study closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Study halted prematurely, prior to enrollment of first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Genomics Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Ramesh Ramanathan, M.D., Principal investigator, Translational Genomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954876
- Sponsor's protocol ID
- MED-P02-07003
- Status last verified
- Oct 2022
- First submitted
- 17 Jul 2009
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multi-Center, Open-Label, Prospective Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type KRAS Colorectal Cancer Who Are Considered Nonoptimal Candidates or Are Intolerant to a First-Line Oxaliplatin/Irinotecan Regimen
- ClinicalTrials.gov ID
- NCT00954876
- Acronym / sponsor ID
- MED-P02-07003
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Translational Genomics Research InstituteUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Aug 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Aug 2009 (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 combination of capecitabine and cetuximab as first-line therapy will result in improved progression free survival compared to single agent capecitabine in patients with KRAS wild type colorectal cancer. Patients who are not able or willing to take Oxaliplatin/Irinotecan combination therapy are eligible for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Metastatic colorectal cancer
- Tumor classified WT KRAS
- At least 18 yrs of age
- ECOG PS 0,1 or 2
- Evidence of adequate organ function
Key exclusion criteria (10 listed)
- Tumors classified as KRAS mutation
- Prior therapy with cetuximab, panitumumab or other agent that targets EGFR
- Prior exposure to any biologic
- Known sensitivity to cetuximab or 5-FU (or marked intolerance to 5-FU)
- Known DPD deficiency
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 and cetuximabCetuximab 500 mg/m2 IV infusion over 1-2 hours Once every 2 weeks Capecitabine 1500 mg/m2 PO BID Days 1-7 followed by 7 days of no treatment and repeated every 2 weeks | Drug | – |
Primary outcome
Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab
Time frame: 18 months
4 secondary outcomes
To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
Time frame: 18 months
To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
Time frame: 18 months
To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population
Time frame: every three months
To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy.
Time frame: 1 year after study closure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
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CRC
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.
Ramesh Ramanathan, M.D. principal investigator
Translational Genomics
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 capecitabine and cetuximab in people with Metastatic Colorectal Cancer, run by Translational Genomics Research Institute 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 12 inclusion and 10 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: withdrawn, as of the sponsor's last update on 20 Oct 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab (time frame: 18 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 20 Oct 2022.