Metastatic Colorectal CancerPhase 2NCT01832467
Cetuximab Rechallenge Study
A Phase 2 study testing cetuximab-containing chemotherapy in people with Metastatic Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
To determine the objective overall response of re-treatment with cetuximab-based chemotherapy in patients upon disease progression while under observation, who had previously responded to first-line or second-line treatment with cetuximab-based chemotherapy for metastatic colorectal cancer (mCRC), but had stopped… 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?
- cetuximab-containing chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Apr 2013to 7 Apr 2020
- 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
- Age 18 years or older.
- Able to give written informed consent.
- Histologically confirmed colorectal adenocarcinoma: must be either metastatic disease or unresectable recurrent disease.
- KRAS mutation status of the primary or metastastic CRC tumor must be wild-type.
- ECOG performance status of 0-1 at study entry.
- Must have measurable disease by RECIST (ver 1.1) criteria.
Show all 12Show fewer
- Have progressive disease based on all of the following criteria (from a-d):
- Previously received cetuximab-based chemotherapy as first- or second-line treatment for metastatic or recurrent disease with, any one of the following drug combinations: (i) Cetuximab, fluoropyrimidines and oxaliplatin; or, (ii) Cetuximab, fluoropyrimidines and irinotecan; or (iii) Cetuximab and irinotecan. (b) Must have achieved at least stable disease, partial or complete response to treatment stated in '(a)' above.
- Experienced disease progression after more than 60 days from the last date of administration of the treatment stated in '(a)' above.
- 'Disease progression' can be defined as radiological or clinical progression.
- Adequate hematologic, renal, hepatic function as defined by: absolute neutrophil count >= 1.5 x 109/L, hemoglobin >= 9 g/L, platelets >= 100 x 109/L, calculated creatinine clearance >=55 ml/min, total bilirubin <= 2 x the upper limit of normal (ULN), alanine aminotransferase (ALT) <2.5 upper limit of normal or <= 5 x ULN in the presence of liver metastases.
- Must have recovered to grade 0-1 in severity, any toxicity related to previous cetuximab.
Who cannot join
- Disease progression during first-line or second-line treatment with cetuximab and chemotherapy in combination.
- Patients who had prior cetuximab in BOTH first and second-line setting.
- Previous use of bevacizumab.
- Prior grade 3 to 4 hypersensitivity reaction to cetuximab.
- Clinically significant and poorly controlled medical illnesses within the last 6 months which may be exacerbated by study treatment.
- Estimated life expectancy of less than 3 months.
Show all 13Show fewer
- Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before enrollment. Radiotherapy for pain relief is allowed as long as not targeted at an index or non-index lesion, e.g., bone metastases.
- Known brain and/or leptomeningeal metastases.
- Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias
- Pregnancy or lactation
- Previous malignancy other than colorectal cancer in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix. The non-CRC malignancy must be in known complete remission for at least 5 years prior to enrollment.
- The presence of KRAS mutation in any of the CRC tumor tissue(s) - for example, patients with synchronous primary CRCs with different KRAS mutation status.
- Participants with reproductive potential who are unwilling to perform effective contraception.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
Official title: A Pilot Case-control Study of Second or Third Line Treatment With Cetuximab-containing Chemotherapy in Patients With Metastatic Colorectal Cancer Who Were Previously Treated With Cetuximab-based Chemotherapy
To determine the objective overall response of re-treatment with cetuximab-based chemotherapy in patients upon disease progression while under observation, who had previously responded to first-line or second-line treatment with cetuximab-based chemotherapy for metastatic colorectal cancer (mCRC), but had stopped treatment for reasons other than disease progression.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- cetuximab-containing chemotherapy
- Keywords
- cetuximab-based chemotherapy, previously treated
- 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-containing chemotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| cetuximab-containing chemotherapy | Experimental | * Cetuximab may be given at either one of the following schedules at the investigator's discretion:
1. 2-weekly: Cetuximab is started on day 1 of each cycle of chemotherapy, at 500mg/m2 every 2 weeks over 120/90/60minutes.
2. Weekly: Cetuximab may be given at a loading dose of 400mg/m2 on day 1over 120 minutes, followed by weekly dosing at 250mg/m2 on day 1, over 60 minutes of each cycle of chemotherapy.
* Chemotherapy: Only one of the following regimens may be combined with cetuximab at the investigator's discretion according to institutional standard. Some recommended regimens used in Hong Kong.
Regimens to be combined with biweekly cetuximab:
1. Irinotecan at 2-weekly schedule.
2. FOLFIRI (as inpatient or via ambulatory pump).
3. FOLFOX (as inpatient or via ambulatory pump). Receives: Drug: cetuximab-containing chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response of re-treatment with cetuximab-based chemotherapy
in patients experiencing disease progression while under observation, who had previously responded to first-line or second-line treatment with cetuximab-based chemotherapy for metastatic colorectal cancer (mCRC), but had stopped treatment for reasons other than disease progression.
Measured: 2 years
Secondary outcomes (3)
Adverst event and toxicity during treatment period
Measured: 2 years
disease control rate
Measured: 2 years
progression-free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study start24 Apr 2013
- Primary completion7 Apr 2020
- Study completion7 Apr 2020
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.
- More trials run by Chinese University of Hong KongThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Brigette MA, MD, FRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832467
- Sponsor's protocol ID
- COL019
- Status last verified
- Jun 2020
- First submitted
- 10 Apr 2013
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Case-control Study of Second or Third Line Treatment With Cetuximab-containing Chemotherapy in Patients With Metastatic Colorectal Cancer Who Were Previously Treated With Cetuximab-based Chemotherapy
- ClinicalTrials.gov ID
- NCT01832467
- Acronym / sponsor ID
- COL019
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- cetuximab-based chemotherapy, previously treated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 24 Apr 2013
- Primary completion
- 7 Apr 2020 (actual)
- Study completion
- 7 Apr 2020 (actual)
- First posted
- 16 Apr 2013 (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.
To determine the objective overall response of re-treatment with cetuximab-based chemotherapy in patients upon disease progression while under observation, who had previously responded to first-line or second-line treatment with cetuximab-based chemotherapy for metastatic colorectal cancer (mCRC), but had stopped treatment for reasons other than disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cetuximab-containing chemotherapy | Experimental | Drug: cetuximab-containing chemotherapy* Cetuximab may be given at either one of the following schedules at the investigator's discretion: 1. 2-weekly: Cetuximab is started on day 1 of each cycle of chemotherapy, at 500mg/m2 every 2 weeks over 120/90/60minutes. 2. Weekly: Cetuximab may be given at a loading dose of 400mg/m2 on day 1over 120 minutes, followed by weekly dosing at 250mg/m2 on day 1, over 60 minutes of each cycle of chemotherapy. * Chemotherapy: Only one of the following regimens may be combined with cetuximab at the investigator's discretion according to institutional standard. Some recommended regimens used in Hong Kong. Regimens to be combined with biweekly cetuximab: 1. Irinotecan at 2-weekly schedule. 2. FOLFIRI (as inpatient or via ambulatory pump). 3. FOLFOX (as inpatient or via ambulatory pump). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 years or older.
- Able to give written informed consent.
- Histologically confirmed colorectal adenocarcinoma: must be either metastatic disease or unresectable recurrent disease.
- KRAS mutation status of the primary or metastastic CRC tumor must be wild-type.
- ECOG performance status of 0-1 at study entry.
Key exclusion criteria (13 listed)
- Disease progression during first-line or second-line treatment with cetuximab and chemotherapy in combination.
- Patients who had prior cetuximab in BOTH first and second-line setting.
- Previous use of bevacizumab.
- Prior grade 3 to 4 hypersensitivity reaction to cetuximab.
- Clinically significant and poorly controlled medical illnesses within the last 6 months which may be exacerbated by study treatment.
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-containing chemotherapy | Drug | cetuximab-containing chemotherapy |
Primary outcome
overall response of re-treatment with cetuximab-based chemotherapy
Time frame: 2 years
in patients experiencing disease progression while under observation, who had previously responded to first-line or second-line treatment with cetuximab-based chemotherapy for metastatic colorectal cancer (mCRC), but had stopped treatment for reasons other than disease progression.
3 secondary outcomes
Adverst event and toxicity during treatment period
Time frame: 2 years
disease control rate
Time frame: 2 years
progression-free survival
Time frame: 2 years
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 18 Jun 2020.
Related trials for Metastatic Colorectal Cancer
Not yet recruitingPhase 2/3
Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
RecruitingPhase 2
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
Cervical Cancer, Throat Cancer
Not yet recruiting
T1 Colorectal Cancer After Local Excision: Decision Between Surgery and Active Surveillance (T1LDA Trial)
Colorectal Cancer
RecruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers
Metastatic Colorectal Carcinoma, Metastatic Malignant Solid Neoplasm
RecruitingPhase 2
Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment
Refractory Metastatic 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.
Brigette MA, MD, FRCP principal investigator
Chinese University of Hong Kong
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-containing chemotherapy in people with Metastatic Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 13 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 18 Jun 2020. 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 Hong Kong. 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 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?
overall response of re-treatment with cetuximab-based chemotherapy (time frame: 2 years). 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 18 Jun 2020.