Incurable Colorectal CancerPhase 2NCT02071069
Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer
A Phase 2 study testing Cetuximab, irinotecan and fluorouracil in people with Incurable Colorectal Cancer and RAS-wild-type, run by Tianshu Liu at 1 site in China.
Trial summary
1. To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and fluorouracil(FOLFIRI) in patients with incurable colorectal cancer. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incurable Colorectal Cancer, RAS-wild-type
- What is being tested?
- Cetuximab, irinotecan and fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Jul 2016
- 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
- Patients aged ≥18 years with histologically confirmed metastatic colorectal cancer
- Eastern Cooperative Oncology Group performance status ≤2 and
- life expectancy of >3 months were enrolled.
- All patients had to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
- None was previous exposure to Cetuximab or irinotecan .
- Patients had to have adequate haematological (absolute neutrophil count >1.5 × 109/l; platelet count >100 × 109/l; haemoglobin >9 g/dl), hepatic [total bilirubin <1.5 × the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase <2.5 × ULN, or <5 × ULN in the case of hepatic metastases or <10 × ULN in the case of osseous metastases; alkaline phosphatase <2.5 × ULN, or <5 × ULN or <10 × ULN in the case of hepatic or osseous metastases, respectively] and renal function (creatinine clearance ≥60 ml/min)
- All RAS were wildtype. -
Who cannot join
- Pregnant or breast-feeding women;
- Clinically significant cardiac disease;
- Lack of physical integrity of the upper gastrointestinal tract;
- History of other malignancy;
- Central nervous system metastases. -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Tianshu Liu, Doctor, liu.tianshu@zs-hospital.sh.cn
Yiyi yu, Master
About this study
Official title: Efficacy and Tolerance of Cetuximab Combined With Irinotecan or Fluorouracil as Maintenance Therapy in Patients With RAS-wild-type Incurable Advanced Colorectal Cancer （Confirm Study）
- To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and fluorouracil(FOLFIRI) in patients with incurable colorectal cancer.
- The relevant phase III studies reported that the progression free-survival of cetuximab combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months.
This study assumed that the progression free-survival was 5.1 months which was not inferior to the continuous chemotherapy
- Conditions
- Incurable Colorectal Cancer, RAS-wild-type
- Being tested
- Cetuximab, irinotecan, fluorouracil
- Keywords
- Incurable colorectal cancer, maintenance therapy, Cetuximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks
irinotecanDrug
180 mg/m2 IV every 2 weeks
fluorouracilDrug
Also called 5FU
400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| maintenance therapy | Experimental | Initially, all subjects received 8 cycles of Cetuximab (400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks)plus FOLFIRI (irinotecan 180 mg/m2 IV on day 1 , leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks) .
After 8 cycles or severe toxicity, patients received maintenance therapy comprising Cetuximab (250mg/m2 every week or 500mg/m2 every 2 weeks) and either irinotecan( 180 mg/m2 IV every 2 weeks) or fluorouracil arm( leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks ). In cases of unacceptable toxicity, only the related medication was stopped Receives: Drug: Cetuximab; Drug: irinotecan; Drug: fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The progression free-survival
defined as the time from enrollment to progression or death RECIST guidelines were used to define all responses after patients had received every 8 weeks of therapy
Measured: 8 Months after the last subject participate in
Secondary outcomes (2)
Overall survival
defined as the time from enrollment to death
Measured: 18 Months after the last subject participate in
Grade 3 and 4 adverse Events as a Measure of Safety and Tolerability
Toxicity was graded according to the criteria of the National Cancer Institute Common Terminology for Adverse Events (version 4.0).
Measured: 3 Months after the last subject end the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startJul 2013
- Primary completionMay 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incurable 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianshu Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tianshu Liu, Shanghai Zhongshan Hospital
- Investigators
- Tianshu Liu, Doctor, Principal investigator, Medicine-Oncology Derpartment of Zhongshan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071069
- Sponsor's protocol ID
- ZS-ON-05
- Status last verified
- Nov 2015
- First submitted
- 19 Feb 2014
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of Cetuximab Combined With Irinotecan or Fluorouracil as Maintenance Therapy in Patients With RAS-wild-type Incurable Advanced Colorectal Cancer （Confirm Study）
- ClinicalTrials.gov ID
- NCT02071069
- Acronym / sponsor ID
- ZS-ON-05
- Conditions
- Incurable Colorectal Cancer, RAS-wild-type
- Keywords
- Incurable colorectal cancer, maintenance therapy, Cetuximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Tianshu LiuUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- May 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 25 Feb 2014 (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 evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and fluorouracil(FOLFIRI) in patients with incurable colorectal cancer.
- The relevant phase III studies reported that the progression free-survival of cetuximab combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months.
This study assumed that the progression free-survival was 5.1 months which was not inferior to the continuous chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| maintenance therapy | Experimental | Drug: Cetuximab, Drug: irinotecan, Drug: fluorouracilInitially, all subjects received 8 cycles of Cetuximab (400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks)plus FOLFIRI (irinotecan 180 mg/m2 IV on day 1 , leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks) . After 8 cycles or severe toxicity, patients received maintenance therapy comprising Cetuximab (250mg/m2 every week or 500mg/m2 every 2 weeks) and either irinotecan( 180 mg/m2 IV every 2 weeks) or fluorouracil arm( leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks ). In cases of unacceptable toxicity, only the related medication was stopped |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged ≥18 years with histologically confirmed metastatic colorectal cancer
- Eastern Cooperative Oncology Group performance status ≤2 and
- life expectancy of >3 months were enrolled.
- All patients had to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
- None was previous exposure to Cetuximab or irinotecan .
Key exclusion criteria (5 listed)
- Pregnant or breast-feeding women;
- Clinically significant cardiac disease;
- Lack of physical integrity of the upper gastrointestinal tract;
- History of other malignancy;
- Central nervous system metastases. -
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 |
|---|---|---|
| Cetuximab400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks | Drug | maintenance therapy |
| irinotecan180 mg/m2 IV every 2 weeks | Drug | maintenance therapy |
| fluorouracilAlso: 5FU400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks | Drug | maintenance therapy |
Primary outcome
The progression free-survival
Time frame: 8 Months after the last subject participate in
defined as the time from enrollment to progression or death RECIST guidelines were used to define all responses after patients had received every 8 weeks of therapy
2 secondary outcomes
Overall survival
Time frame: 18 Months after the last subject participate in
Grade 3 and 4 adverse Events as a Measure of Safety and Tolerability
Time frame: 3 Months after the last subject end the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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.
Tianshu Liu, Doctor principal investigator
Medicine-Oncology Derpartment of Zhongshan hospital
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, irinotecan and fluorouracil in people with Incurable Colorectal Cancer and RAS-wild-type, run by Tianshu Liu at 1 site in China.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Nov 2015. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianshu Liu, Doctor (+861368 1973 996, liu.tianshu@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The progression free-survival (time frame: 8 Months after the last subject participate in). 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 Nov 2015.