Colorectal CancerPhase 1NCT00392470
Radiation Therapy, Irinotecan, and Cetuximab in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Rectal Cancer
A Phase 1 study testing cetuximab, irinotecan hydrochloride and conventional surgery in people with Colorectal Cancer, run by Centre Hospitalier Universitaire Vaudois at 3 sites in Switzerland.
Trial summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- cetuximab, irinotecan hydrochloride and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Aug 2006to not given
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the rectum
- T3-4 and/or N+ (stage IIIB, IIIC, or IV disease)
- Liver or lung metastasis allowed
- No recurrent disease
PATIENT CHARACTERISTICS:
- WHO performance status 0 or 1
- Hematologic, liver, and renal function normal
- Considered fit for chemotherapy, radiotherapy, and surgery
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No symptomatic heart disease or myocardial infarction during the past 6 months
- No chronic inflammatory bowel disease
- No malignant tumor during the past 5 years except for completely surgically resected carcinoma of the cervix or squamous cell carcinoma of the skin
- No other concurrent malignant tumor
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for rectal cancer
- No prior radiotherapy to the pelvis
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites, 3 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, CH-5000
Peter Moosmann, MD, PhD, 41-62-838-6051, peter.moosmann@ksa.ch
- Recruiting
Institut Ludwig de Recherche sur le Cancer
Épalinges, 1066
Curzio Ruegg, MD, 44-412-1692-5853
- Recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
Michael Montemurro, MD, 41-21-314-4530
About this study
Official title: Neoadjuvant Conformal Radiotherapy and Concomitant CPT-11 and EGFR Inhibition With Cetuximab in Patients With Rectal Cancer Phase I Study
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with irinotecan and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with cetuximab and radiation therapy in treating patients who are undergoing surgery for stage III or stage IV rectal cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the toxicity of irinotecan hydrochloride and cetuximab in patients with stage III or IV rectal cancer undergoing conformal or intensity-modulated radiotherapy.
Secondary
- Determine the rate of pathologic response and histological degree of tumor regression in patients treated with this regimen.
- Determine the complete resection rate (R0) in patients treated with this regimen.
- Determine the sphincter preservation rate in patients treated with this regimen.
- Determine the 30-day postoperative complication rate in patients treated with this regimen.
- Determine the local and distant relapse rate and site of disease failure in patients treated with this regimen.
- Estimate the predictive value of fludeoxyglucose F 18 positron emission tomography/CT scan for treatment response compared to endoscopic ultrasonography (EUS), CT scan, and MRI in patients treated with this regimen.
- Determine the late toxicity of this regimen in these patients.
- Determine the clinical (radiological) tumor response (i.e., MRI, CT scan, EUS) in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of irinotecan hydrochloride.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43 followed by irinotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22, and 29. Patients also undergo conformal radiotherapy or intensity-modulated radiotherapy on days 1-5 for 5 weeks. Patients undergo radical surgery 3-4 weeks after completion of neoadjuvant therapy.
Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- cetuximab, irinotecan hydrochloride, conventional surgery, neoadjuvant therapy, 3-dimensional conformal radiation therapy
- Keywords
- adenocarcinoma of the rectum, stage III rectal cancer, stage IV rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabBiological
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
3-dimensional conformal radiation therapyRadiation
intensity-modulated radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological (clinical) tumor response before surgery
Pathologic response rate and histological degree of tumor regression as measured by Mandard TRG score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startAug 2006
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.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Investigators
- Michael Montemurro, MD, Study chair, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392470
- Sponsor's protocol ID
- CDR0000512816
- Other IDs
- CHUV-CEPO-CORCC-204-5, EU-20645, PFIZER-CHUV-CAPO-CARK-204-5, MERCK-CHUV-CAPO-CARK-204-5
- Status last verified
- Apr 2008
- First submitted
- 25 Oct 2006
- Last updated
- 25 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Conformal Radiotherapy and Concomitant CPT-11 and EGFR Inhibition With Cetuximab in Patients With Rectal Cancer Phase I Study
- ClinicalTrials.gov ID
- NCT00392470
- Acronym / sponsor ID
- CDR0000512816
- Conditions
- Colorectal Cancer
- Keywords
- adenocarcinoma of the rectum, stage III rectal cancer, stage IV rectal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Aug 2006
- First posted
- 26 Oct 2006 (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.
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with irinotecan and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with cetuximab and radiation therapy in treating patients who are undergoing surgery for stage III or stage IV rectal cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the toxicity of irinotecan hydrochloride and cetuximab in patients with stage III or IV rectal cancer undergoing conformal or intensity-modulated radiotherapy.
Secondary
- Determine the rate of pathologic response and histological degree of tumor regression in patients treated with this regimen.
- Determine the complete resection rate (R0) in patients treated with this regimen.
- Determine the sphincter preservation rate in patients treated with this regimen.
- Determine the 30-day postoperative complication rate in patients treated with this regimen.
- Determine the local and distant relapse rate and site of disease failure in patients treated with this regimen.
- Estimate the predictive value of fludeoxyglucose F 18 positron emission tomography/CT scan for treatment response compared to endoscopic ultrasonography (EUS), CT scan, and MRI in patients treated with this regimen.
- Determine the late toxicity of this regimen in these patients.
- Determine the clinical (radiological) tumor response (i.e., MRI, CT scan, EUS) in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of irinotecan hydrochloride.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43 followed by irinotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22, and 29. Patients also undergo conformal radiotherapy or intensity-modulated radiotherapy on days 1-5 for 5 weeks. Patients undergo radical surgery 3-4 weeks after completion of neoadjuvant therapy.
Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | Biological | – |
| irinotecan hydrochloride | Drug | – |
| conventional surgery | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
| 3-dimensional conformal radiation therapy | Radiation | – |
| intensity-modulated radiation therapy | Radiation | – |
Primary outcome
Radiological (clinical) tumor response before surgery
Pathologic response rate and histological degree of tumor regression as measured by Mandard TRG score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2011.
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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.
Michael Montemurro, MD study chair
Centre Hospitalier Universitaire Vaudois
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cetuximab, irinotecan hydrochloride and conventional surgery in people with Colorectal Cancer, run by Centre Hospitalier Universitaire Vaudois at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 25 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological (clinical) tumor response before surgery. 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 25 May 2011.