Colorectal CancerPhase 2NCT00251186
First-Line Capecitabine and Cetuximab for Metastatic Colorectal Ca in Elderly Patients
A Phase 2 study testing Capecitabine and Cetuximab in people with Colorectal Cancer, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
This is a Phase II clinical trial measuring the effectiveness of the combination of Capecitabine and cetuximab for first line treatment of colorectal cancer in elderly patients and/or those with multiple comorbidities unable to receive standard chemotherapy. This study will be open approximately 2-3 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Capecitabine and Cetuximab
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Apr 2006
- 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
- Histologically or cytologically proven diagnosis of locally extensive or metastatic colorectal cancer, not amenable to curative therapy.
- No prior therapy for metastatic disease. Only 5-fluorouracil and leucovorin chemotherapy in the adjuvant setting will be allowed and the last treatment was given more then 6 months prior to metastatic disease development.
- Patients with an ECOG performance score of 2 AND/OR Charlson comorbidity index of ³ 4.
- Patients must be documented by the physician to be medically unable to tolerate oxaliplatin and/or irinotecan based chemotherapy.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ³ 20 mm with conventional techniques or as ³10 mm with spiral CT scan.
- Life expectancy of greater than 3 months.
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- Laboratory values showing adequate organ function prior to going on-study:
- Absolute neutrophil count (ANC) ≥ 2.5 x 109/L
- Platelets (PLT) 100 x 109/L
- Hemoglobin 9g/dl (with or without transfusion)
- Metabolic:Calculated creatinine clearance > 50 ml/min
- Total Bilirubin £ 1.5 x Upper limit of normal (ULN)
- AST £ 3 x ULN
- Patient should be able to ingest oral medication.
- Ability to understand and sign an approved informed consent.
Who cannot join
- Patients with uncontrolled systemic disease other than the patient's colorectal cancer (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) for which the patient was admitted to the hospital within the prior month. Patients with stable respiratory, cardiac, hepatic or renal disease may participate subject to the guidelines in the eligibility criteria above.
- Presence of dementia or delirium.
- Unable to eat, dress, bathe or use the toilet independently. The patient must be able to ambulate independently unless limited by arthritis or musculoskeletal condition.
- Patients with active gastritis within the last 3 months prior to study entry.
- No synchronous or prior malignancy other than non-melanomatous skin cancer or insitu carcinoma of the cervix, unless disease free > 3 years.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
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- Pregnant women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus. Women must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Men and women must be willing to use adequate birth control measures to prevent contraception.
- Inability to or unwillingness to comply with protocol defined treatment and assessments.
- Prior therapy that specifically and directly targets the EGFR pathway.
- Prior severe infusion reaction to a monoclonal antibody.
- Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
- Patients ingesting herbal supplements, botanicals or vitamins in excess of recommended daily dose must be willing to stop their use, 1 week prior to study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
About this study
Official title: Phase II Study of First-Line Capecitabine and Cetuximab for Treatment of Metastatic Colorectal Cancer in Elderly Patients and/or Those With Multiple Comorbidities Unable to Receive Chemotherapy Doublets
This is a Phase II clinical trial measuring the effectiveness of the combination of Capecitabine and cetuximab for first line treatment of colorectal cancer in elderly patients and/or those with multiple comorbidities unable to receive standard chemotherapy. This study will be open approximately 2-3 years. Approximately 36 patients will be enrolled on this study. The study will begin enrolling at The Cancer Institute of New Jersey, with 17 patients in the first group. If more than 4 responses are noted, the accrual will continue to 36 patients throughout CINJOG.
- Conditions
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
To measure the response (CR/PR) for a novel chemotherapy/biologic combination-capecitabine/cetuximab for patients with metastatic colorectal cancer who are too fragile for more intensive chemotherapy doublet regimens.
Secondary outcomes (4)
Secondary Objectives
To measure progression-free survival and document overall survival in this patient population.
To assess the toxicity of capecitabine/cetuximab
To describe the baseline quality of life and functional characteristics of elderly patients or those with multiple comorbidities enrolled in this study and assess the impact of disease and its treatment on such functional characteristics.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2005 (estimated)
- Study startApr 2006
- Primary completionApr 2006
- Study completionApr 2006
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 18 participants
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, Bristol-Myers Squibb
- Investigators
- Elizabeth Poplin, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251186
- Sponsor's protocol ID
- 5536
- Other IDs
- CINJ 070502
- Status last verified
- Jan 2010
- First submitted
- 7 Nov 2005
- Last updated
- 26 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of First-Line Capecitabine and Cetuximab for Treatment of Metastatic Colorectal Cancer in Elderly Patients and/or Those With Multiple Comorbidities Unable to Receive Chemotherapy Doublets
- ClinicalTrials.gov ID
- NCT00251186
- Acronym / sponsor ID
- 5536
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding unavailable
- Enrolment
- 18 participants
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, Bristol-Myers Squibb
- Study start
- Apr 2006
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 9 Nov 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 is a Phase II clinical trial measuring the effectiveness of the combination of Capecitabine and cetuximab for first line treatment of colorectal cancer in elderly patients and/or those with multiple comorbidities unable to receive standard chemotherapy. This study will be open approximately 2-3 years. Approximately 36 patients will be enrolled on this study. The study will begin enrolling at The Cancer Institute of New Jersey, with 17 patients in the first group. If more than 4 responses are noted, the accrual will continue to 36 patients throughout CINJOG.
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 (15 listed)
- Histologically or cytologically proven diagnosis of locally extensive or metastatic colorectal cancer, not amenable to curative therapy.
- No prior therapy for metastatic disease. Only 5-fluorouracil and leucovorin chemotherapy in the adjuvant setting will be allowed and the last treatment was given more then 6 months prior to metastatic disease development.
- Patients with an ECOG performance score of 2 AND/OR Charlson comorbidity index of ³ 4.
- Patients must be documented by the physician to be medically unable to tolerate oxaliplatin and/or irinotecan based chemotherapy.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ³ 20 mm with conventional techniques or as ³10 mm with spiral CT scan.
Key exclusion criteria (12 listed)
- Patients with uncontrolled systemic disease other than the patient's colorectal cancer (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) for which the patient was admitted to the hospital within the prior month. Patients with stable respiratory, cardiac, hepatic or renal disease may participate subject to the guidelines in the eligibility criteria above.
- Presence of dementia or delirium.
- Unable to eat, dress, bathe or use the toilet independently. The patient must be able to ambulate independently unless limited by arthritis or musculoskeletal condition.
- Patients with active gastritis within the last 3 months prior to study entry.
- No synchronous or prior malignancy other than non-melanomatous skin cancer or insitu carcinoma of the cervix, unless disease free > 3 years.
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 Cetuximab | Drug | – |
Primary outcome
Primary Objective
To measure the response (CR/PR) for a novel chemotherapy/biologic combination-capecitabine/cetuximab for patients with metastatic colorectal cancer who are too fragile for more intensive chemotherapy doublet regimens.
4 secondary outcomes
Secondary Objectives
To measure progression-free survival and document overall survival in this patient population.
To assess the toxicity of capecitabine/cetuximab
To describe the baseline quality of life and functional characteristics of elderly patients or those with multiple comorbidities enrolled in this study and assess the impact of disease and its treatment on such functional characteristics.
Results and safety
The study was stopped early (reason given: Funding unavailable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
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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.
Elizabeth Poplin, MD principal investigator
Rutgers, The State University of New Jersey
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 Colorectal Cancer, run by University of Medicine and Dentistry of New Jersey 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 15 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: stopped early, as of the sponsor's last update on 26 Jan 2010. 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 stopped early (reason given: Funding unavailable). 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.
What does the primary outcome measure?
Primary Objective. 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 26 Jan 2010.