Metastatic Colorectal CancerPhase 2NCT01243047
Intermittent Versus Continuous Tarceva Study
A Phase 2 study testing Chemotherapy in people with Metastatic Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a randomized phase II study comprising of two treatment arms in patients who are previously untreated for metastatic or recurrent colorectal cancer. 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?
- Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2007to Oct 2012
- 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.
- ECOG performance status of 0-2.
- Histological proof of adenocarcinoma of colon or rectum with evidence of metastatic disease.
- At least one unidimensionally measurable lesion with a diameter >20 mm using conventional CT or MRI scans, or > 10 mm with spiral CT
- No prior drug treatment or chemotherapy for metastatic disease.
- No prior HER2 or EGFR inhibitors. No prior Oxaliplatin in any clinical setting.
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- Absolute granulocyte count > 1.5 x 109/L, platelet count > 100 x 109/L, hemoglobin level > 9.0 g/L, INR < 1.5.
- Adequate renal \& hepatic functions: serum creatinine < 1.5 x upper limit of normal (ULN) or calculated creatinine clearance > 50ml/min, serum bilirubin < 1.5 x ULN, ALT < 2.5 x ULN or < 5 x ULN in case of liver metastases, albumin level > 30g/dL).
- Prior adjuvant or neoadjuvant chemotherapy for non-metastatic CRC is allowed if > 3 months has elapsed since the last dose of chemotherapy.
- Prior open surgery is allowed if > 28 days* has elapsed since the date of surgery, wound healing is satisfactory and recovery from any complications from the surgery is adequate. (*For laparoscopic surgery, > 14 days from the date of surgery).
- No serious medical conditions such as myocardial infarction within 6 months prior to entry, or any other medical conditions that might be aggravated by treatment
Who cannot join
- Prior history of any malignancies, except basal cell cancer of skin, cervical CIN.
- Treatment with radiotherapy < 30 days.
- Pregnant or lactating females
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Patients who have not recovered from surgery or other medical illness such as infection.
- Evidence of central nervous system disease. Patients with a history of uncontrolled seizures, central nervous disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded from the study
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- Patients lacking physical integrity of upper gastrointestinal tract or malabsorption syndrome or unable to swallow tablets.
- Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency).
- Interstitial pneumonia or extensive symptomatic fibrosis of the lungs.
- Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.
- Known peripheral neuropathy ≥ NCI CTC grade 1.
- Current or recent (within 10 days prior to study treatment start) use of full-dose oral anticoagulant (e.g. warfarin) or thrombolytic agent.
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: Intermittent Versus Continuous Erlotinib With Concomitant Modified 'Xelox' (q3W) in First-line Treatment of Metastatic Colorectal Cancer
This is a randomized phase II study comprising of two treatment arms in patients who are previously untreated for metastatic or recurrent colorectal cancer.
Read the detailed description
To evaluate two different schedules of erlotinib in combination with a modified XELOX regimen in terms of response rate
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Chemotherapy
- Keywords
- Second line treatment for metastatic 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.
ChemotherapyDrug
Erlotinib, Oxaliplatin, Capecitabine
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Continuous erlotinib administration (21-day cycle). Erlotinib dose given at 100mg daily Receives: Drug: Chemotherapy |
| Arm B | Active comparator | Intermittent erlotinib administration (21-day cycle). Erlotinib dose given at 150mg. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate two different schedules of erlotinib in combination with a modified XELOX regimen in terms of response rate
Measured: 3 years
Secondary outcomes (2)
To evaluate two different schedules of erlotinib and modified XELOX regimen in terms of toxicity, their duration of response and effect on time to progression, progression-free survival and overall survival.
Measured: 3 years
To determine the effect of intermittent versus continuous erlotinib administration on pharmacodynamic endpoints using tumor biopsies
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startSep 2007
- Primary completionOct 2012
- Study completionOct 2012
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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, FRACP, Principal investigator, Department of Clinical Oncology, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243047
- Sponsor's protocol ID
- COL012
- Status last verified
- Nov 2012
- First submitted
- 17 Nov 2010
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Versus Continuous Erlotinib With Concomitant Modified 'Xelox' (q3W) in First-line Treatment of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01243047
- Acronym / sponsor ID
- COL012
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Second line treatment for metastatic colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 Nov 2010 (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 randomized phase II study comprising of two treatment arms in patients who are previously untreated for metastatic or recurrent colorectal cancer.
Detailed description
To evaluate two different schedules of erlotinib in combination with a modified XELOX regimen in terms of response rate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: ChemotherapyContinuous erlotinib administration (21-day cycle). Erlotinib dose given at 100mg daily |
| Arm B | Active comparator | Drug: ChemotherapyIntermittent erlotinib administration (21-day cycle). Erlotinib dose given at 150mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years.
- ECOG performance status of 0-2.
- Histological proof of adenocarcinoma of colon or rectum with evidence of metastatic disease.
- At least one unidimensionally measurable lesion with a diameter >20 mm using conventional CT or MRI scans, or > 10 mm with spiral CT
- No prior drug treatment or chemotherapy for metastatic disease.
Key exclusion criteria (12 listed)
- Prior history of any malignancies, except basal cell cancer of skin, cervical CIN.
- Treatment with radiotherapy < 30 days.
- Pregnant or lactating females
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Patients who have not recovered from surgery or other medical illness such as infection.
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 |
|---|---|---|
| ChemotherapyErlotinib, Oxaliplatin, Capecitabine | Drug | Arm A, Arm B |
Primary outcome
To evaluate two different schedules of erlotinib in combination with a modified XELOX regimen in terms of response rate
Time frame: 3 years
2 secondary outcomes
To evaluate two different schedules of erlotinib and modified XELOX regimen in terms of toxicity, their duration of response and effect on time to progression, progression-free survival and overall survival.
Time frame: 3 years
To determine the effect of intermittent versus continuous erlotinib administration on pharmacodynamic endpoints using tumor biopsies
Time frame: 3 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 22 Nov 2012.
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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.
Brigette Ma, MD, FRACP principal investigator
Department of Clinical Oncology, The 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 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 11 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 22 Nov 2012. 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?
To evaluate two different schedules of erlotinib in combination with a modified XELOX regimen in terms of response rate (time frame: 3 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 22 Nov 2012; AzTrials last refreshed its copy on 28 Oct 2026.