Carcinoma, Squamous CellNCT01142869
An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy in the First-line Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
An observational study of Carcinoma, Squamous Cell, run by Merck KGaA, Darmstadt, Germany at 28 sites in India.
Trial summary
The aim of this prospective, observational, multicenter, post-marketing study is to evaluate the safety and efficacy of Cetuximab (Erbitux) in combination with platinum based chemotherapy, in the first line therapy of recurrent/ metastatic squamous cell carcinoma of head and neck (SCCHN). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Squamous Cell
- What is being tested?
- Cetuximab
- Type of treatment
- Injection or infusion
- How many people
- 133 participants
- Where
- 28 sitesIndia
- Study dates
- 31 Dec 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: Patients with squamous cell carcinoma of head and neck
Who may be able to join
- The study inclusion criteria is as per the label for patients with metastatic/recurrent SCCHN approved by India Health Authorities, i.e., "Cetuximab is indicated for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease."
- For each platinum-based chemotherapy, the related product labels approved by India Health Authorities will also be followed strictly in terms of patient eligibility.
Who cannot join
- Patients with known severe (grade 3 or 4; National Cancer Institute-Common Toxicity Criteria [NCI-CTC]) hypersensitivity reactions to Cetuximab are contraindicated for Cetuximab
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
India28 sites
Grace Nursing Home
Aizawl, Mizoram, 796 009
Dr. T. P. Sahoo's Clinic
Bhopal, Madhya Pradesh, 462001
Sunil Gupta's Clinic
Delhi, 110092
Global Health Pvt Ltd
Gurgaon, Haryana, 122001
Ambaa Hospitals
Hyderabad, Andhra Pradesh, 500008
Indo- American Cancer Institute & Research Centre
Hyderabad, Andhra Pradesh, 500034
NVS Ramakrishna's Clinic
Hyderabad, Andhra Pradesh, 500063
Cancer Clinic
Jaipur, Rajasthan, 302004
SMS Hospital
Jaipur, Rajasthan, 302004
Bhagwan Mahaveer Cancer Hospital
Jaipur, Rajasthan, 302006
J.K.Cancer Institute
Kanpur, Uttar Pradesh, 208002
The Cancer Clinic
Kochi, Kerala, 682304
B.R. Singh Hospital
Kolkata, West Bengal, 700014
Apollo Gleneagles Cancer Hospital
Kolkata, West Bengal, 700054
Annapurna Medical and Cancer Relief Society
Lucknow, Uttar Pradesh, 226007
BND Onco Centre
Mumbai, Maharashtra, 400014
S.L.Raheja Hospital
Mumbai, Maharashtra, 400016
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Dr. Vineet's Clinic
New Delhi, Uttar Pradesh, 110085
SMH-Curie Cancer Centre, Shanti Mukand Hospital
New Delhi, Uttar Pradesh, 110092
Sparsh Hospital
Orissa, Bhubaneswar, 751007
S M Karandikar's Clinic
Pune, Maharashtra, 400014
Ruby Hall Clinic
Pune, Maharashtra, 411001
Galaxy Care Laproscopic Institute
Pune, Maharashtra, 411004
Dr. Nikhil's Clinic
Secunderabad, Andhra Pradesh, 500025
Swarna Sai Hospital
Secunderabad, Andhra Pradesh, 500059
Neigrihms
Shillong, Meghālaya, 793005
Wellness Consultants Clinic
Surat, Gujarat, 395002
About this study
Official title: An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy, in the First-line Therapy of Recurrent/ Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
The aim of this prospective, observational, multicenter, post-marketing study is to evaluate the safety and efficacy of Cetuximab (Erbitux) in combination with platinum based chemotherapy, in the first line therapy of recurrent/ metastatic squamous cell carcinoma of head and neck (SCCHN). A total of 100 subjects with SCCHN will be recruited in 20 centres across India.
- Conditions
- Carcinoma, Squamous Cell
- Being tested
- Cetuximab
- Keywords
- Carcinoma, Squamous Cell, Erbitux, Neoplasms, Squamous Cell
- Medical subject headings
- Carcinoma, Squamous Cell, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
The starting dose will be intravenous (IV) cetuximab 400 mg/m2 body surface area administered as a 120-minute infusion once a week . The subsequent weekly doses will be IV cetuximab 250 mg/m2 administered as a 60-minute infusion. The maximum infusion rate must not exceed 10 mg/min.
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN.
Safety variables will include the assessment of incidence and type of adverse drug reactions (ADRs), serious adverse drug reactions (SADRs), incidence of withdrawals due to intolerability of cetuximab and severity of adverse events (AEs)
Measured: From first infusion of cetuximab until 28 days after the last infusion.
Secondary outcomes (1)
To obtain clinical effectiveness information of Cetuximab in combination with platinum based chemotherapy in patients with recurrent/ metastatic SCCHN.
Clinical efficacy will be assessed by best tumor response, disease control rate, progression-free survival and overall survival with cetuximab treatment.
Measured: From first infusion of cetuximab until 28 days after the last infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study start31 Dec 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 Carcinoma, Squamous CellStudies 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
- 133 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
- Dr. Rajiv Rana, Study director, Merck Ltd., India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142869
- Sponsor's protocol ID
- EMR 062202-514
- Status last verified
- May 2017
- First submitted
- 10 Jun 2010
- Last updated
- 8 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 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 Cetuximab in Combination With Platinum-based Chemotherapy, in the First-line Therapy of Recurrent/ Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
- ClinicalTrials.gov ID
- NCT01142869
- Acronym / sponsor ID
- EMR 062202-514
- Conditions
- Carcinoma, Squamous Cell
- Keywords
- Carcinoma, Squamous Cell, Erbitux, Neoplasms, Squamous Cell
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was discontinued due to slow recruitment and subjects not completing follow up period.
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Ltd., India
- Study start
- 31 Dec 2009 (actual)
- Primary completion
- 31 Jul 2013 (actual)
- Study completion
- 5 Aug 2014 (actual)
- First posted
- 11 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.
The aim of this prospective, observational, multicenter, post-marketing study is to evaluate the safety and efficacy of Cetuximab (Erbitux) in combination with platinum based chemotherapy, in the first line therapy of recurrent/ metastatic squamous cell carcinoma of head and neck (SCCHN). A total of 100 subjects with SCCHN will be recruited in 20 centres across India.
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
- Patients with squamous cell carcinoma of head and neck
Key inclusion criteria (2 listed)
- The study inclusion criteria is as per the label for patients with metastatic/recurrent SCCHN approved by India Health Authorities, i.e., "Cetuximab is indicated for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease."
- For each platinum-based chemotherapy, the related product labels approved by India Health Authorities will also be followed strictly in terms of patient eligibility.
Key exclusion criteria (1 listed)
- Patients with known severe (grade 3 or 4; National Cancer Institute-Common Toxicity Criteria [NCI-CTC]) hypersensitivity reactions to Cetuximab are contraindicated for 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: ErbituxThe starting dose will be intravenous (IV) cetuximab 400 mg/m2 body surface area administered as a 120-minute infusion once a week . The subsequent weekly doses will be IV cetuximab 250 mg/m2 administered as a 60-minute infusion. The maximum infusion rate must not exceed 10 mg/min. | Drug | – |
Primary outcome
To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN.
Time frame: From first infusion of cetuximab until 28 days after the last infusion.
Safety variables will include the assessment of incidence and type of adverse drug reactions (ADRs), serious adverse drug reactions (SADRs), incidence of withdrawals due to intolerability of cetuximab and severity of adverse events (AEs)
1 secondary outcome
To obtain clinical effectiveness information of Cetuximab in combination with platinum based chemotherapy in patients with recurrent/ metastatic SCCHN.
Time frame: From first infusion of cetuximab until 28 days after the last infusion.
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 8 May 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.
Dr. Rajiv Rana study director
Merck Ltd., India
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Squamous Cell, run by Merck KGaA, Darmstadt, Germany at 28 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 2 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 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN. (time frame: From first infusion of cetuximab until 28 days after the last infusion.). 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 8 May 2017.