Colorectal NeoplasmsNCT01134666
An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer
An observational study of Colorectal Neoplasms, run by Merck KGaA, Darmstadt, Germany at 40 sites in India.
Trial summary
This is an open-label, non-randomized, prospective, multicentric, Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Cetuximab
- Type of treatment
- Injection or infusion
- How many people
- 165 participants
- Where
- 40 sitesIndia
- Study dates
- 30 Nov 2009to 5 Aug 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with KRAS wild-type CRC receiving FOLFOX/FOLFIRI and cetuximab in India.
Who may be able to join
- Subjects with histologically confirmed, adenocarcinoma of the colon or rectum (mCRC)
- Subjects with KRAS wild-type status of tumour tissue
- Chemotherapy naïve subjects
- Subject who have signed written informed consent (as per institutional protocol)
Who cannot join
- As per summary of product characteristics of cetuximab
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
India40 sites
Hemato Oncology Clinic
Ahmedabad, Gujarat, 380009
Grace Nursing Home
Aizawl, Mizoram, 796 009
Fortis Escorts Hospital
Amritsar, Punjab, 143004
Lilavati Hospital
Bandra, Mumbai, 400050
Dr. T. P. Sahoo's Clinic
Bhopal, Madhya Pradesh, 462001
Dr. Rajeev Bedi's Clinic
Chandigarh, Punjab, 160101
Apollo Cancer Institute
Delhi, New Delhi, 110044
Rajiv Gandhi Cancer Institute & Research
Delhi, New Delhi, 110085
Nothern Railway Central Hospital
Delhi, 110055
Indraprastha Apollo Hospital
Delhi, 110076
Shanti Mukand Hospital
Delhi, 110092
Dharamshila Cancer Hospital & Research Centre
Delhi, 110096
Shati Gopal Hospital
Ghaziabad, Uttar Pradesh, 201014
Kattimani Oncology Clinic
Hubli, Karnataka, 580020
Indo- American Cancer Institute & Research Centre
Hyderabad, Andhra Pradesh, 500034
NVS Ramakrishna's Clinic
Hyderabad, Andhra Pradesh, 500063
Ravi Kumar's Clinic
Hyderabad, Andrapradesh, 500001
Ambaa Hospitals
Hyderabad, Andrapradesh, 500008
Swarna Sai Hospital
Hyderabad, Andrapradesh, 500059
Cancer Clinic
Jaipur, Rajasthan, 302004
SMS Hospital
Jaipur, Rajasthan, 302004
Bhagwan Mahaveer Cancer Hospital
Jaipur, Rajasthan, 302006
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, Rajasthan, 302030
Vyas Cancer Care
Jodhpur, Rajasthan, 3420003
Medical College Calicut
Kerala, Calicut, 673016
Chittaranjan National Cancer Institute
Kolkata, West Bengal, 700026
Apollo Gleneagles Cancer Hospital
Kolkata, West Bengal, 700054
Annapurna Medical and Cancer Relief Society
Lucknow, Uttar Pradesh, 226007
D.M.C Hospital
Ludhiana, Punjab, 141001
S.L.Raheja Hospital
Mahīm, Mumbai, 400016
Manipal Centre For Clinical Research
Mangalore, Bangalore, 575 001
IVY Hospital
Mohali, Punjab, 160071
BND Onco Centre
Mumbai, Maharashtra, 400014
Joy Hospital
Mumbai, Maharashtra, 400071
Ruby Hall Clinic
Pune, Maharashtra, 411001
Dr. Nikhil's Clinic
Secunderabad, Andhra Pradesh, 500025
Nikhil Gharyalpatil's Clinic
Secunderabad, Andhra Pradesh, 500025
SKIMS
Srinagar, Jammu and Kashmir, 190001
S. K. I. M. S.
Srinagar, Jammu and Kashmir, 190010
TC 14/ 764 Sreemangalam
Trivandrum, Tamil Nadu, 695011
About this study
This is an open-label, non-randomized, prospective, multicentric, Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC.
Read the detailed description
Cetuximab, a chimeric immunoglobulin G1 (IgG1) monoclonal antibody, has been found to potentiate the effects of chemotherapy and radiotherapy in experimental systems. The findings from clinical trials suggest a favorable risk-benefit ratio of the combination of irinotecan or oxaliplatin, infusional 5-FU/FA and biweekly cetuximab, and support the current study to demonstrate the therapeutic value of the biweekly cetuximab regimen as a combination partner for those regimens in subjects with KRAS wild-type mCRC in the first-line setting. The purpose of this study is to generate post marketing surveillance (PMS) data for cetuximab in first-line mCRC, which is mandated by the Licensing Authorities.
This is an open-label, non-randomized, prospective, multicentric Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC. The study plans to enroll 100 subjects with KRAS wild type CRC at 20 centres across India. Tumour status, physical and laboratory examinations will be performed during the baseline visit. Subjects will be administered FOLFIRI/ FOLFOX and cetuximab according to the clinical condition in the following treatment visits. Regular safety assessments and all adverse events (AEs) will be documented throughout and until the end-of-study visit. The outcome of AEs ongoing at the final tumour assessment visit will be followed up at the end-of-study visit (If possible, 6 weeks after the last administration of study medication but before second-line anticancer treatment, and not earlier than 30 days after the end of study treatment). Skin toxicity present at the end-of-study visit will be followed up until outcome is known.
OBJECTIVES
Primary Objective:
- To evaluate the safety and tolerability of Cetuximab in combination with standard chemotherapy such as FOLFOX or FOLFIRI as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
Secondary Objective:
- To evaluate the efficacy of Cetuximab in combination with standard chemotherapy as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
- Conditions
- Colorectal Neoplasms
- Being tested
- Cetuximab
- Keywords
- Colorectal neoplasms, Intestinal neoplasms, Neoplasms, cetuximab, Erbitux
- Medical subject headings
- Colorectal Neoplasms, Intestinal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
FOLFOX Oxaliplatin 100 mg/ m2 day 1 Folinic Acid 400 mg/m² (racemic) or 200 mg/m² (L-form) day 1 5- FU 400 mg/m² bolus on day 1 followed by a 46-hour continuous infusion of 2,400 mg/m² day 1 FOLFIRI Irinotecan 180 mg/ m2 day 1 Folinic Acid 400 mg/m² (racemic) or 200 mg/m² (L-form) day 1 5- FU 400 mg/m² bolus on day 1 followed by a 46-hour continuous infusion of 2,400 mg/m² day 1 CETUXIMAB Cetuximab administered at loading dose of 400 mg/m2/week over 120 min followed by maintenance dose of 250 mg/m2/ week over 60 min, till disease progression or dose limiting toxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability evaluated based on the incidence and severity of AEs.
Measured: From baseline to follow-up visit for any ongoing AEs
Secondary outcomes (1)
Response rate
Disease Control Rate (DCR), Progression Free Survival (PFS)and Overall Survival (OS)
Measured: Baseline to End-of-Study Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study start30 Nov 2009
- Primary completion31 Jul 2013
- Study completion5 Aug 2014
Why it stopped: The study was discontinued due to slow recruitment and subjects not completing follow up period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Ltd., India
- Responsible party
- Sponsor
- Investigators
- Rajiv Rana, MD, Study director, Merck Ltd., India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134666
- Sponsor's protocol ID
- EMR 062202-517
- Status last verified
- Jun 2017
- First submitted
- 28 May 2010
- Last updated
- 9 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01134666
- Acronym / sponsor ID
- EMR 062202-517
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal neoplasms, Intestinal neoplasms, Neoplasms, cetuximab, Erbitux
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was discontinued due to slow recruitment and subjects not completing follow up period.
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Ltd., India
- Study start
- 30 Nov 2009 (actual)
- Primary completion
- 31 Jul 2013 (actual)
- Study completion
- 5 Aug 2014 (actual)
- First posted
- 2 Jun 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 an open-label, non-randomized, prospective, multicentric, Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC.
Detailed description
Cetuximab, a chimeric immunoglobulin G1 (IgG1) monoclonal antibody, has been found to potentiate the effects of chemotherapy and radiotherapy in experimental systems. The findings from clinical trials suggest a favorable risk-benefit ratio of the combination of irinotecan or oxaliplatin, infusional 5-FU/FA and biweekly cetuximab, and support the current study to demonstrate the therapeutic value of the biweekly cetuximab regimen as a combination partner for those regimens in subjects with KRAS wild-type mCRC in the first-line setting. The purpose of this study is to generate post marketing surveillance (PMS) data for cetuximab in first-line mCRC, which is mandated by the Licensing Authorities.
This is an open-label, non-randomized, prospective, multicentric Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC. The study plans to enroll 100 subjects with KRAS wild type CRC at 20 centres across India. Tumour status, physical and laboratory examinations will be performed during the baseline visit. Subjects will be administered FOLFIRI/ FOLFOX and cetuximab according to the clinical condition in the following treatment visits. Regular safety assessments and all adverse events (AEs) will be documented throughout and until the end-of-study visit. The outcome of AEs ongoing at the final tumour assessment visit will be followed up at the end-of-study visit (If possible, 6 weeks after the last administration of study medication but before second-line anticancer treatment, and not earlier than 30 days after the end of study treatment). Skin toxicity present at the end-of-study visit will be followed up until outcome is known.
OBJECTIVES
Primary Objective:
- To evaluate the safety and tolerability of Cetuximab in combination with standard chemotherapy such as FOLFOX or FOLFIRI as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
Secondary Objective:
- To evaluate the efficacy of Cetuximab in combination with standard chemotherapy as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with KRAS wild-type CRC receiving FOLFOX/FOLFIRI and cetuximab in India.
Key inclusion criteria (4 listed)
- Subjects with histologically confirmed, adenocarcinoma of the colon or rectum (mCRC)
- Subjects with KRAS wild-type status of tumour tissue
- Chemotherapy naïve subjects
- Subject who have signed written informed consent (as per institutional protocol)
Key exclusion criteria (1 listed)
- As per summary of product characteristics of cetuximab
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 |
|---|---|---|
| CetuximabAlso: ErbituxFOLFOX Oxaliplatin 100 mg/ m2 day 1 Folinic Acid 400 mg/m² (racemic) or 200 mg/m² (L-form) day 1 5- FU 400 mg/m² bolus on day 1 followed by a 46-hour continuous infusion of 2,400 mg/m² day 1 FOLFIRI Irinotecan 180 mg/ m2 day 1 Folinic Acid 400 mg/m² (racemic) or 200 mg/m² (L-form) day 1 5- FU 400 mg/m² bolus on day 1 followed by a 46-hour continuous infusion of 2,400 mg/m² day 1 CETUXIMAB Cetuximab administered at loading dose of 400 mg/m2/week over 120 min followed by maintenance dose of 250 mg/m2/ week over 60 min, till disease progression or dose limiting toxicity | Drug | – |
Primary outcome
Safety and tolerability evaluated based on the incidence and severity of AEs.
Time frame: From baseline to follow-up visit for any ongoing AEs
1 secondary outcome
Response rate
Time frame: Baseline to End-of-Study Visit
Results and safety
The study was stopped early (reason given: The study was discontinued due to slow recruitment and subjects not completing follow up period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
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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.
Rajiv Rana, MD study director
Merck Ltd., India
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Merck KGaA, Darmstadt, Germany at 40 sites in India.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in India. 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.
Are results available for this study?
The study was stopped early (reason given: The study was discontinued due to slow recruitment and subjects not completing follow up period.). Results are not available in the source record.
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?
Safety and tolerability evaluated based on the incidence and severity of AEs. (time frame: From baseline to follow-up visit for any ongoing AEs). 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 9 Jun 2017.