Advanced Colorectal CancerPhase 2NCT00972465
Study of Nimotuzumab to Treat Colorectal Cancer
A Phase 2 study testing Nimotuzumab and chemotherapy in people with Advanced Colorectal Cancer, run by Peking University at 3 sites in China.
Trial summary
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- Nimotuzumab and chemotherapy
- How many people
- 48 participants
- Where
- 3 sitesChina
- Study dates
- Jun 2009to Apr 2010
- 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
- Informed consent form signed before performing any of the study's specific procedures.
- ECOG performance status 0-2.
- Age > 18，both genders.
- Metastatic colorectal cancer confirmed by pathology, or locally advanced unresectable colorectal cancer, or postoperative recurrence and metastasis colorectal cancer
- Disease progression after receiving oxaliplatin ± fluorouracil in first-line treatment
- At least 1 measurable lesions ,( longest diameter≥ 1 cm by spiral computed tomography (CT) scan or MRI)
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- Life expectancy more than 3 months.
- K-ras is wild type
- Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
- Liver metastasis, lesions smaller than 50% of the liver; Lung metastasis, lesions smaller than 30% of the lung
- Haemoglobin≥90g/L , granulocyte≥1.5×109/L ,WBC ≥3×109/L, platelet count≥100×109/L
- TBIL≤ 1.5 x ULN ,ALK≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis），AST and ALT≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis）,Creatinine ≤ 1.5 x ULN
- No brain metastasis
Who cannot join
- Previous radiotherapy at lesions within three months
- Other first line chemo-agents treatment except oxaliplatin ± fluorouracil
- Received other anti EGFR monoclonal antibody treatment
- Complete or incomplete intestinal obstruction
- Participation in other interventional clinical trials within 1 month
- Psychiatric disease affected cognitive ability, including brain metastasis
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- Peripheral neuropathy lesion is more than I stage
- History of serious allergic or allergy
- Pregnant or breast-feeding women
- Patients with the history of Serious lung or hear disease
- Other malignant tumor
Trial locations and contacts
3 sites in 1 country.
Shen Lin contact
China3 sites, 3 recruiting
- Recruiting
Peking University, School of Oncology, Beijing Cancer Hospital & Institute
Beijing
Jun Zhou, MD. PhD, 88196088, joelbmu@126.com
- Not yet recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
ruihua Xu, M.D., Ph.D., 13922206676, xurh@mail.sysu.edu.cn
- Not yet recruiting
China People's Liberation Army (PLA)81 Hospital
Nanjing
Shukui Qin, 13905158713, qinshukui@csco.org.cn
About this study
Official title: Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.
Read the detailed description
Nimotuzumab and Irinotecan will be administered to the patient until disease progression or development of toxicity preclude further treatment.Irinotecan will be administered once every 14 days,the dosage is 180mg/m2; Nimotuzumab treatment be divided 3 levels:200mg/w,400mg/w,600mg/w,weekly.The patients'blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks,when the total result is the CR or PR, the result of the 6th and the 12th week should be compared.
- Conditions
- Advanced Colorectal Cancer
- Being tested
- Nimotuzumab and chemotherapy
- Keywords
- nimotuzumab colorectal cancer chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimotuzumab and chemotherapyDrug
Also called Nimotuzumab
Experimental: Nimotuzumab and Irinotecan
the chemotherapy treatment: Irinotecan (180 mg/m2/time, 1 time/14 days, until disease progression)
the nimotuzumab treatment: 3 levels (200 mg/w, 400 mg/w, 600 mg/w, weekly, until disease progression)
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.
Measured: within study period
Secondary outcomes (1)
To determine the complete response rate, partial rate, disease response rate, disease control rate in the patients subject to treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Biotech Pharmaceutical Co., Ltd.
- Investigators
- Shen Lin, Principal investigator, Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972465
- Sponsor's protocol ID
- BT-CRC-T
- Status last verified
- Sep 2009
- First submitted
- 4 Sep 2009
- Last updated
- 7 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras
- ClinicalTrials.gov ID
- NCT00972465
- Acronym / sponsor ID
- BT-CRC-T
- Conditions
- Advanced Colorectal Cancer
- Keywords
- nimotuzumab colorectal cancer chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Biotech Pharmaceutical Co., Ltd.
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 7 Sep 2009 (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.
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.
Detailed description
Nimotuzumab and Irinotecan will be administered to the patient until disease progression or development of toxicity preclude further treatment.Irinotecan will be administered once every 14 days,the dosage is 180mg/m2; Nimotuzumab treatment be divided 3 levels:200mg/w,400mg/w,600mg/w,weekly.The patients'blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks,when the total result is the CR or PR, the result of the 6th and the 12th week should be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Informed consent form signed before performing any of the study's specific procedures.
- ECOG performance status 0-2.
- Age > 18，both genders.
- Metastatic colorectal cancer confirmed by pathology, or locally advanced unresectable colorectal cancer, or postoperative recurrence and metastasis colorectal cancer
- Disease progression after receiving oxaliplatin ± fluorouracil in first-line treatment
Key exclusion criteria (11 listed)
- Previous radiotherapy at lesions within three months
- Other first line chemo-agents treatment except oxaliplatin ± fluorouracil
- Received other anti EGFR monoclonal antibody treatment
- Complete or incomplete intestinal obstruction
- Participation in other interventional clinical trials within 1 month
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 |
|---|---|---|
| Nimotuzumab and chemotherapyAlso: NimotuzumabExperimental: Nimotuzumab and Irinotecan the chemotherapy treatment: Irinotecan (180 mg/m2/time, 1 time/14 days, until disease progression) the nimotuzumab treatment: 3 levels (200 mg/w, 400 mg/w, 600 mg/w, weekly, until disease progression) | Drug | – |
Primary outcome
Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.
Time frame: within study period
1 secondary outcome
To determine the complete response rate, partial rate, disease response rate, disease control rate in the patients subject to treatment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2009.
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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.
Shen Lin contact
Shen Lin principal investigator
Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab and chemotherapy in people with Advanced Colorectal Cancer, run by Peking University at 3 sites 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 13 inclusion and 11 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 7 Sep 2009. 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 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 Shen Lin (86-01-88196561), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated. (time frame: within study period). 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 7 Sep 2009.