Metastatic Colorectal CancerPhase 2NCT00531115
Phase II Study to Evaluate Safety and Efficacy of Cetuximab in Combination With XELOX for 12 Weeks Followed by Maintenance Treatment With Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer.
A Phase 2 study testing cetuximab 5mg/ml in people with Metastatic Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
Trial summary
The purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab plus XELOX for 4 cycles followed by maintenance treatment with cetuximab plus capecitabine as first line treatment in elderly patients with metastatic colorectal cancer Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- cetuximab 5mg/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2007to Apr 2009
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Signed written informed consent before any study related activities are carried out
- Men and women >= 70 years.
- Histologically confirmed diagnosis of CRC.
- Non-resectable and/or non-operable metastatic colorectal carcinoma.
- Presence of at least one lesion by two-dimensional measurement; index lesions should not be in a region with previous irradiation.
- Availability of tumor tissue for immunohistochemical analysis
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- Karnofsky functional status >= 80% at the time of enrollment in the study.
- Life expectancy greater than 3 months.
- Patients will not have received chemotherapy for advanced or metastatic disease. Patients with the following characteristics will be included: 1. Recurrence after neoadjuvant and/or adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with disease-free interval > 12 months following conclusion of treatment. 2. Recurrence after surgical and/or radiotherapy treatment without adjuvant systemic treatment. 3. De novo diagnosis of disease.
- Proper hematological, renal and hepatic function,
Who cannot join
- Documented or suspected cerebral and/or leptomeningeal metastases.
- Surgery (excluding biopsy for diagnosis) and/or radiotherapy during the 4 weeks prior to inclusion in the study.
- Chronic, concomitant systemic immunotherapy, chemotherapy, or hormonal treatment for cancer.
- Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment.
- Participation in another clinical trial with medication in the past 30 days
- Prior participation in a study in which treatment with cetuximab may be assigned (whether or not treatment with cetuximab is received).
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- Prior malignant tumor in the past 5 years, except for history of adequately treated basal cell skin cancer or pre-invasive cervical cancer .
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome or history of inflammatory intestinal disease, acute or subacute intestinal occlusion or other disease which could alter drug absorption.
- Evidence of grade 3 or 4 allergic reaction to any treatment components or other fluoropyrimidines.
- Clinically relevant peripheral neuropathy.
- Clinically significant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of decompensation of heart failure or arrhythmia.
- Serious active infections (requiring intravenous antibiotics), including active tuberculosis and diagnosed HIV.
- Known abuse of alcohol/drugs.
- Legal incapacity or limited legal capacity.
- Any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent.
- Patients catalogued as delicate or "frail" for compliance with any of the following criteria
- Dependence in one or more activities of daily life according to the Katz Activity of Daily Living (ADL) scale.
- 3 or more comorbid entities based on evaluation of the presence of the following processes: congestive heart failure; valvular heart disease; coronary artery disease; obstructive or restrictive chronic pulmonary disease; cerebrovascular disease; peripheral neuropathies; chronic renal failure; hypertension; diabetes; concomitant neoplasms; collagen vascular diseases; and incapacitating arthritis.
- Presence of geriatric syndromes: moderate-severe dementia; delirium in situation of stress (urinary or respiratory infection, angina or drugs); moderate-severe depression that interferes with usual activity of patient; frequent falls (3 or more per month); lack of care (Who could help him or her in the event of an emergency?); urinary incontinence in the absence of stress, infection, diuretics or prostatic hyperplasia; fecal incontinence in the absence of diarrhea or laxatives; osteoporotic fractures of long bones or vertebral crush.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, 28046
About this study
Official title: Multicentre, Single-arm, Phase II Study to Evaluate Safety and Efficacy of Cetuximab in Combination With Oxaliplatin and Capecitabine (XELOX) for 12 Weeks Followed by Maintenance Treatment With Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer.
The purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab plus XELOX for 4 cycles followed by maintenance treatment with cetuximab plus capecitabine as first line treatment in elderly patients with metastatic colorectal cancer
Read the detailed description
- This open-label, non-controlled, multicentre, phase II study will recruit 53 elderly patients with diagnosis of metastatic colorectal cancer.
- All patients will receive 4 cycles of treatment with cetuximab plus XELOX followed by cetuximab plus capecitabine as maintenance therapy until progression of disease, occurrence of unacceptable toxicity to the study drugs, or withdrawal of consent by the patient.
- The planned duration of a cycle is 3 weeks.
- Cetuximab therapy will not be delayed for chemotherapy-related toxicity and vice versa. If patients benefit from combination therapy, but develop unacceptable intolerance to oxaliplatin and/or capecitabine, cetuximab may be continued in combination with the other chemotherapy drug and/or as a single agent. In case of cetuximab intolerance, patients should continue with chemotherapy treatment until progression disease.
- Evaluations:
- Efficacy data (response rate, progression-free survival, duration of response and survival) and safety data will be collected. The investigators will assess responses to treatment.
- When the treatment is stopped either because of disease progression or occurrence of unacceptable toxicity, the patients will enter a follow-up period where the progression-free survival, the subsequent lines of treatment and the survival data will be collected every 12 weeks.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- cetuximab 5mg/ml
- Keywords
- metastatic colorectal cancer, elderly patients, cetuximab, oxaliplatin, 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.
cetuximab 5mg/mlDrug
Weekly administration of Cetuximab (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes) Oxaliplatin. 130 mg/m2 every three weeks. on day 1 for 4 cycles Capecitabine. 1000 mg/m2 twice daily (2.000 mg/m2 total daily dose) or 750 mg/m2 if Cl Cr=30-50 ml/min (1500 mg/m2 total daily dose) for two weeks (on days 1 to 14) followed by one week of rest (on days 15 to 21).
The patients will receive 4 cycles of cetuximab plus combination chemotherapy administered every 3 weeks in order to achieve a noticeable response. Then, oxaliplatin treatment will be stopped after a maximum of 4 infusions to prevent appearance of neuropathy and then followed by capecitabine 2 weeks out of 3, and cetuximab weekly as maintenance treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: cetuximab 5mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed objective response rate
Measured: 2007-2009
Secondary outcomes (2)
Disease control, Time to progression, progression-free survival,Time to treatment failure,Determine time to onset of response, Duration of response, Overall survival, To determine biologic prognostic factors
Measured: 2007-2009
Treatment safety
Measured: 2007-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: According to the study design, in the first step the number of responses was lower than the number required (\< 7).
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Javier Sastre, Study chair, H. Clinico San Carlos. Madrid. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531115
- Sponsor's protocol ID
- TTD-06-05
- Other IDs
- EudraCT Nº: 2006-007062-11
- Status last verified
- Feb 2013
- First submitted
- 17 Sep 2007
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Single-arm, Phase II Study to Evaluate Safety and Efficacy of Cetuximab in Combination With Oxaliplatin and Capecitabine (XELOX) for 12 Weeks Followed by Maintenance Treatment With Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT00531115
- Acronym / sponsor ID
- TTD-06-05
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- metastatic colorectal cancer, elderly patients, cetuximab, oxaliplatin, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: According to the study design, in the first step the number of responses was lower than the number required (\< 7).
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 18 Sep 2007 (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 purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab plus XELOX for 4 cycles followed by maintenance treatment with cetuximab plus capecitabine as first line treatment in elderly patients with metastatic colorectal cancer
Detailed description
- This open-label, non-controlled, multicentre, phase II study will recruit 53 elderly patients with diagnosis of metastatic colorectal cancer.
- All patients will receive 4 cycles of treatment with cetuximab plus XELOX followed by cetuximab plus capecitabine as maintenance therapy until progression of disease, occurrence of unacceptable toxicity to the study drugs, or withdrawal of consent by the patient.
- The planned duration of a cycle is 3 weeks.
- Cetuximab therapy will not be delayed for chemotherapy-related toxicity and vice versa. If patients benefit from combination therapy, but develop unacceptable intolerance to oxaliplatin and/or capecitabine, cetuximab may be continued in combination with the other chemotherapy drug and/or as a single agent. In case of cetuximab intolerance, patients should continue with chemotherapy treatment until progression disease.
- Evaluations:
- Efficacy data (response rate, progression-free survival, duration of response and survival) and safety data will be collected. The investigators will assess responses to treatment.
- When the treatment is stopped either because of disease progression or occurrence of unacceptable toxicity, the patients will enter a follow-up period where the progression-free survival, the subsequent lines of treatment and the survival data will be collected every 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: cetuximab 5mg/ml |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Signed written informed consent before any study related activities are carried out
- Men and women >= 70 years.
- Histologically confirmed diagnosis of CRC.
- Non-resectable and/or non-operable metastatic colorectal carcinoma.
- Presence of at least one lesion by two-dimensional measurement; index lesions should not be in a region with previous irradiation.
Key exclusion criteria (19 listed)
- Documented or suspected cerebral and/or leptomeningeal metastases.
- Surgery (excluding biopsy for diagnosis) and/or radiotherapy during the 4 weeks prior to inclusion in the study.
- Chronic, concomitant systemic immunotherapy, chemotherapy, or hormonal treatment for cancer.
- Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment.
- Participation in another clinical trial with medication in the past 30 days
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 |
|---|---|---|
| cetuximab 5mg/mlWeekly administration of Cetuximab (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes) Oxaliplatin. 130 mg/m2 every three weeks. on day 1 for 4 cycles Capecitabine. 1000 mg/m2 twice daily (2.000 mg/m2 total daily dose) or 750 mg/m2 if Cl Cr=30-50 ml/min (1500 mg/m2 total daily dose) for two weeks (on days 1 to 14) followed by one week of rest (on days 15 to 21). The patients will receive 4 cycles of cetuximab plus combination chemotherapy administered every 3 weeks in order to achieve a noticeable response. Then, oxaliplatin treatment will be stopped after a maximum of 4 infusions to prevent appearance of neuropathy and then followed by capecitabine 2 weeks out of 3, and cetuximab weekly as maintenance treatment. | Drug | 1 |
Primary outcome
Confirmed objective response rate
Time frame: 2007-2009
2 secondary outcomes
Disease control, Time to progression, progression-free survival,Time to treatment failure,Determine time to onset of response, Duration of response, Overall survival, To determine biologic prognostic factors
Time frame: 2007-2009
Treatment safety
Time frame: 2007-2009
Results and safety
The study was stopped early (reason given: According to the study design, in the first step the number of responses was lower than the number required (\< 7).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- Related InfoLink provided by the sponsor.
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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.
Javier Sastre study chair
H. Clinico San Carlos. Madrid. Spain
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 cetuximab 5mg/ml in people with Metastatic Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
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 19 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 20 Feb 2013. 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 Spain. 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: According to the study design, in the first step the number of responses was lower than the number required (\< 7).). 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?
Confirmed objective response rate (time frame: 2007-2009). 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 Feb 2013.