Metastatic Colorectal CancerPROSPECT-CNCT02994888
PROSPECT-C: A Study of Biomarkers of Response or Resistance to Anti-EGFR Therapies in Metastatic Colorectal Cancer
An observational study of Metastatic Colorectal Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
PROSPECT-C is a phase II study investigating the molecular markers of response or resistance to anti-epidermal growth factor receptor (EGFR) antibodies. 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?
- Cetuximab
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with a histologically confirmed diagnosis of metastatic colorectal adenocarcinoma
Who may be able to join
- patients with a histologically confirmed diagnosis of metastatic colorectal adenocarcinoma
- wild-type RAS tumour status by molecular analysis at the Royal Marsden Hospital
- patients with inoperable metastatic colorectal cancer who are scheduled to be treated with cetuximab (or panitumumab) either as monotherapy or in combination with chemotherapy with palliative intent
- patients who have received prior treatment with oxaliplatin, irinotecan and fluoropyrimidine containing chemotherapy regimens OR intolerance/contraindication to either oxaliplatin or irinotecan based chemotherapy, and planned to receive retreatment with EGFR monoclonal antibody (mAB) monotherapy or with EGFR mAB combined with a chemotherapy (irinotecan or oxaliplatin-based) that a patient has already received for a minimum of 3 months during a previous line of therapy.
- patients who have metastatic disease sites which are amenable to core biopsy (preferably liver, soft tissue or nodal disease, with at least one lesion 3cm or more in diameter. If largest lesion 2-3cm diameter, eligibility to be discussed with radiologist prior to study entry)
- patients aged 18 years or older
- able to provide fully informed consent, to comply with the trial and follow-up procedures
- receiving treatment at the Royal Marsden Hospital
Who cannot join
- patients who have previously received treatment with cetuximab or panitumumab
- previous malignancy other than colorectal cancer in the past 5 years, other than pre-invasive malignancy of the cervix or basal cell carcinoma, EXCEPT when the patient has histological confirmation of metastatic colorectal cancer at the site that is planned to be biopsied at baseline and on progression of disease
- patients who are being anti-coagulated with warfarin or heparin
- Patients that are participating in another clinical trial involving an investigational medicinal product, unless it is more than 14 days after they have ceased the investigational medicinal product
- Patients that are participating in another research study involving tumour tissue biopsies planned to take place during the time that the patient is participating in this study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Surrey, Sutton, SM2 5PT
About this study
Official title: PROSPECT-C: A Prospective Translational Study Investigating Molecular Predictors of Resistance and Response to Cetuximab or Panitumumab in Metastatic Colorectal Cancer
PROSPECT-C is a phase II study investigating the molecular markers of response or resistance to anti-epidermal growth factor receptor (EGFR) antibodies.
Read the detailed description
Cetuximab or panitumumab are two monoclonal antibodies that are routinely offered to patients with metastatic colorectal cancer when they have no mutation in RAS genes. In Royal Marsden Hospital patients, who are refractory to all standard therapies and have metastatic colorectal cancer are offered one of these agents in third line metastatic setting. Whilst the mechanisms of response/resistance to these therapies are well studies, they are still incompletely understood. The main hypothesis of this study is that finding mechanisms of response and/or resistance by using novel techniques such as next generation sequencing (NGS) and/or digital droplet polymerase chain reaction (ddPCR) to these therapies will allow better patient selection and application of precision medicine in such patients.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Cetuximab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
All patients will be offered cetuximab 500mg/m2 every 2 weeks, until the time of progression
| Study group | Role | What they receive |
|---|---|---|
| all patients | All patients will be treated with cetuximab 500mg/m2 every 2 weeks until the time of progression Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Track and validate specific known mechanisms of resistance/response to anti-EGFR therapies through
digital droplet polymerase chain reaction (ddPCR) and ultra deep next generation sequencing (NGS) analyses of circulating tumour deoxyribonucleic acid (ct-DNA) obtained every 4 weeks during the course of treatment. Mutations found in ctDNA will also be analysed in the archival and fresh tissue specimens, used for diagnostic testing and obtained during the study respectively
Measured: 3-4 years
Secondary outcomes (1)
Identify novel biomarkers of resistance to anti-EGFR therapies through whole exome sequencing
DNA extracted from pre- and post-treatment metastatic colorectal cancer (mCRC) biopsies; Ultra deep targeted sequencing of tumour samples and of ctDNA will be used to assess whether the identified resistance biomarkers are detectable in some patients before treatment initiation and whether this correlates with short progression free survival (PFS) and poor radiological response
Measured: 3-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startNov 2012
- Primary completionDec 2016
- Study completionDec 2016
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 Royal Marsden NHS Foundation TrustThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994888
- Sponsor's protocol ID
- 3770
- Acronym
- PROSPECT-C
- Status last verified
- Dec 2016
- First submitted
- 30 May 2013
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECT-C: A Prospective Translational Study Investigating Molecular Predictors of Resistance and Response to Cetuximab or Panitumumab in Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02994888
- Acronym / sponsor ID
- PROSPECT-C / 3770
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Dec 2016 (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.
PROSPECT-C is a phase II study investigating the molecular markers of response or resistance to anti-epidermal growth factor receptor (EGFR) antibodies.
Detailed description
Cetuximab or panitumumab are two monoclonal antibodies that are routinely offered to patients with metastatic colorectal cancer when they have no mutation in RAS genes. In Royal Marsden Hospital patients, who are refractory to all standard therapies and have metastatic colorectal cancer are offered one of these agents in third line metastatic setting. Whilst the mechanisms of response/resistance to these therapies are well studies, they are still incompletely understood. The main hypothesis of this study is that finding mechanisms of response and/or resistance by using novel techniques such as next generation sequencing (NGS) and/or digital droplet polymerase chain reaction (ddPCR) to these therapies will allow better patient selection and application of precision medicine in such patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients | – | Drug: CetuximabAll patients will be treated with cetuximab 500mg/m2 every 2 weeks until the time of progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a histologically confirmed diagnosis of metastatic colorectal adenocarcinoma
Key inclusion criteria (8 listed)
- patients with a histologically confirmed diagnosis of metastatic colorectal adenocarcinoma
- wild-type RAS tumour status by molecular analysis at the Royal Marsden Hospital
- patients with inoperable metastatic colorectal cancer who are scheduled to be treated with cetuximab (or panitumumab) either as monotherapy or in combination with chemotherapy with palliative intent
- patients who have received prior treatment with oxaliplatin, irinotecan and fluoropyrimidine containing chemotherapy regimens OR intolerance/contraindication to either oxaliplatin or irinotecan based chemotherapy, and planned to receive retreatment with EGFR monoclonal antibody (mAB) monotherapy or with EGFR mAB combined with a chemotherapy (irinotecan or oxaliplatin-based) that a patient has already received for a minimum of 3 months during a previous line of therapy.
- patients who have metastatic disease sites which are amenable to core biopsy (preferably liver, soft tissue or nodal disease, with at least one lesion 3cm or more in diameter. If largest lesion 2-3cm diameter, eligibility to be discussed with radiologist prior to study entry)
Key exclusion criteria (5 listed)
- patients who have previously received treatment with cetuximab or panitumumab
- previous malignancy other than colorectal cancer in the past 5 years, other than pre-invasive malignancy of the cervix or basal cell carcinoma, EXCEPT when the patient has histological confirmation of metastatic colorectal cancer at the site that is planned to be biopsied at baseline and on progression of disease
- patients who are being anti-coagulated with warfarin or heparin
- Patients that are participating in another clinical trial involving an investigational medicinal product, unless it is more than 14 days after they have ceased the investigational medicinal product
- Patients that are participating in another research study involving tumour tissue biopsies planned to take place during the time that the patient is participating in this study
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 |
|---|---|---|
| CetuximabAll patients will be offered cetuximab 500mg/m2 every 2 weeks, until the time of progression | Drug | all patients |
Primary outcome
Track and validate specific known mechanisms of resistance/response to anti-EGFR therapies through
Time frame: 3-4 years
digital droplet polymerase chain reaction (ddPCR) and ultra deep next generation sequencing (NGS) analyses of circulating tumour deoxyribonucleic acid (ct-DNA) obtained every 4 weeks during the course of treatment. Mutations found in ctDNA will also be analysed in the archival and fresh tissue specimens, used for diagnostic testing and obtained during the study respectively
1 secondary outcome
Identify novel biomarkers of resistance to anti-EGFR therapies through whole exome sequencing
Time frame: 3-4 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 19 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 8 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: finished, as of the sponsor's last update on 19 Dec 2016. 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 United Kingdom. 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 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?
Track and validate specific known mechanisms of resistance/response to anti-EGFR therapies through (time frame: 3-4 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 19 Dec 2016.