Metastatic Colorectal CancerPhase 2NCT00254137
Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.
A Phase 2 study testing capecitabine, irinotecan and oxaliplatin in people with Metastatic Colorectal Cancer, run by Ludwig-Maximilians - University of Munich.
Trial summary
A randomized phase II-study to evaluate the safety and efficacy of capecitabine plus irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in first-line treatment of patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- capecitabine, irinotecan and oxaliplatin
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Nov 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic colorectal cancer.
- EGF-receptor testing.
- No prior chemotherapy for colorectal cancer (except adjuvant chemotherapy with an interval ³ 6 months).
- No prior therapy with topoisomerase-1 inhibitors, no prior therapy directed against the EGF-pathway.
- No prior surgery (except diagnostic biopsy) or radiation therapy 4 weeks before start of study treatment.
- Measurable disease (diameter ³ 20mm, diameter ³ 10mm with spiral-CT).
Show all 9Show fewer
- Male and female patients ³ 18 years, £ 75 years. Karnofsky PS ³ 70%. Life expectancy ³ 3 months. Effective contraception if risk of conception exists.
- Adequate bone marrow, liver and renal function (leucocytes ³3.000/µl, neutrophils ³1.500/µl, platelets ³100.000/µl, hemoglobin ³9g/dl, bilirubin £1,5x ULN, ASAT and ALAT £3x ULN (£5x ULN with liver metastasis), serum creatinine £1,5x ULN).
- Written informed consent.
Who cannot join
- Concurrent treatment of colorectal cancer (except study medication).
- EGF-receptor testing not possible.
- Known DPD-deficiency (no particular screening necessary). Known Gilbert-Meulengracht-Syndrome (no particular screening necessary).
- Known or expected contraindication against study medication.
- Participation in other studies during 30 days before study entry.
- Prior myocardial infarction, severe renal insufficiency (creatinine clearance £30ml/min).
Show all 12Show fewer
- Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment and no sign of disease during 5 years).
- Known or suspected cerebral metastasis.
- History of inflammatory bowel disease. Symptomatic peritoneal carcinomatosis.
- Drug or alcohol abuse. Lack of adequate legal capacity.
- Breast-feeding or pregnant women.
- Concurrent medication with Sorivudine and analoga, anticoagulation with Cumarine or derivatives.
About this study
Official title: A Randomized Phase II-study to Evaluate the Safety and Efficacy of Capecitabine Plus Irinotecan Plus Cetuximab Compared to Capecitabine Plus Oxaliplatin Plus Cetuximab in First-line Treatment of Patients With Metastatic Colorectal Cancer.
A randomized phase II-study to evaluate the safety and efficacy of capecitabine plus irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in first-line treatment of patients with metastatic colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- capecitabine, irinotecan, oxaliplatin, cetuximab
- Keywords
- capecitabine, irinotecan, cetuximab, oxaliplatin, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
irinotecanDrug
oxaliplatinDrug
cetuximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (CR+PR)
Secondary outcomes (4)
Time to progression.
Disease control rate (CR+PR+SD).
Safety profile.
Grade 3/4- toxicities.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startSep 2004
- Study completionNov 2006
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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Sanofi, Pfizer, Hoffmann-La Roche
- Investigators
- Volker Heinemann, PhD, MD, Principal investigator, University of Munich - Klinikum Grosshadern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254137
- Sponsor's protocol ID
- CRC-02-2004
- Status last verified
- Sep 2004
- First submitted
- 14 Nov 2005
- Last updated
- 28 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II-study to Evaluate the Safety and Efficacy of Capecitabine Plus Irinotecan Plus Cetuximab Compared to Capecitabine Plus Oxaliplatin Plus Cetuximab in First-line Treatment of Patients With Metastatic Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT00254137
- Acronym / sponsor ID
- CRC-02-2004
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- capecitabine, irinotecan, cetuximab, oxaliplatin, colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Sanofi, Pfizer, Hoffmann-La Roche
- Study start
- Sep 2004
- Study completion
- Nov 2006
- First posted
- 15 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.
A randomized phase II-study to evaluate the safety and efficacy of capecitabine plus irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in first-line treatment of patients with metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed metastatic colorectal cancer.
- EGF-receptor testing.
- No prior chemotherapy for colorectal cancer (except adjuvant chemotherapy with an interval ³ 6 months).
- No prior therapy with topoisomerase-1 inhibitors, no prior therapy directed against the EGF-pathway.
- No prior surgery (except diagnostic biopsy) or radiation therapy 4 weeks before start of study treatment.
Key exclusion criteria (12 listed)
- Concurrent treatment of colorectal cancer (except study medication).
- EGF-receptor testing not possible.
- Known DPD-deficiency (no particular screening necessary). Known Gilbert-Meulengracht-Syndrome (no particular screening necessary).
- Known or expected contraindication against study medication.
- Participation in other studies during 30 days before study entry.
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 | Drug | – |
| irinotecan | Drug | – |
| oxaliplatin | Drug | – |
| cetuximab | Drug | – |
Primary outcome
Objective response rate (CR+PR)
4 secondary outcomes
Time to progression.
Disease control rate (CR+PR+SD).
Safety profile.
Grade 3/4- toxicities.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
Related trials for Metastatic Colorectal Cancer
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
RecruitingPhase 1
Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer
Metastatic Colorectal Adenocarcinoma, Recurrent Colorectal Adenocarcinoma
Active, not recruitingPhase 2
CBX-12 for the Treatment of Metastatic Chemotherapy-Refractory Microsatellite Stable Colorectal Cancer
Metastatic Mismatch Repair Proficient Colorectal Carcinoma, Refractory Mismatch Repair Proficient Colorectal Carcinoma
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Not yet recruitingObservational study
SGA-OCRC: Prediction of 90-Day Major Adverse Postoperative Outcomes in Octogenarians With Resectable Colorectal Cancer
Octogenarian Patients With Non-metastatic Resectable Colorectal Cancer
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.
Volker Heinemann, PhD, MD principal investigator
University of Munich - Klinikum Grosshadern
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine, irinotecan and oxaliplatin in people with Metastatic Colorectal Cancer, run by Ludwig-Maximilians - University of Munich.
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 9 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: finished, as of the sponsor's last update on 28 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective response rate (CR+PR). 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 28 Oct 2010.