Colorectal CancerPhase 2FRAILNCT01126112
Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-RAS Colorectal Cancer
A Phase 2 study testing Panitumumab in people with Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of first-line single-agent panitumumab in frail elderly patients with advanced Wild Type K-RAS colorectal cancer Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Panitumumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- May 2010to Jul 2014
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Signed Inform Consent
- Age > 70 years.
- Histologically documented metastatic colorectal cancer not candidate for surgical resection
- Wild type K-RAS
- Measurable disease by RECIST Criteria
- Intermediate or High-risk group according to the Köhne Prognostic Classification
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- ECOG status < 3
- Magnesium ≥ institutional lower limit of normal
- frail elderly patients and or not candidates for chemotherapy:
- Frail elderly patients: Presence of one or more of the following criteria:
- Dependence for one of the basic daily living activities (Katz Index)
- Three or more comorbid conditions according Charlson scale and dependence for one of the instrumental activities of daily living (IADL)
- Presence one or more of the following geriatric syndromes (age > 85 years, fecal or urinary incontinence in the absence of stress, frequent falls, spontaneous bone fractures, neglect)
- Presence of one or more of the following criteria that make patients not candidates for chemotherapy:
- neutrophils < 2000/mm3
- platelets < 100.000/mm3
- creatinine clearance < 30 ml/min and bilirubin levels > 1.5 x ULN
- creatinine clearance < 30 ml/min and AST or ALT levels > 3 x UNL (if liver metastasis > 5 x ULN)
Who cannot join
- Patients will be excluded from the study if they have received prior systemic therapy for the treatment of metastatic colorectal carcinoma or antiEGFR therapy, with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to enrolment or oxaliplatin at least 12 months prior to enrolment.
- Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before inclusion
- Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion
- Patients cognitively impaired or with severe depression according mini mental state examination and geriatric depression scale.
- Patients with central nervous system metastases, or those with significant cardiovascular disease, will also be excluded.
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan
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- Treatment for systemic infection within 14 days before initiating study treatment
- Radiotherapy < 14 days prior to inclusion in the study.
- Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day)
- History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results
- Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
- subject allergic to the ingredients of the study medication or to Staphylococcus protein A
- Any co-morbid disease that would increase risk of toxicity
- Any investigational agent within 30 days before enrolment
- Must not have had a major surgical procedure within 28 days of enrolment
- Subject unwilling or unable to comply with study requirements
Trial locations and contacts
1 site in 1 country.
Spain1 site
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, 28046
About this study
Official title: Phase II Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-RAS Colorectal Cancer
The purpose of the study is to evaluate the efficacy and safety of first-line single-agent panitumumab in frail elderly patients with advanced Wild Type K-RAS colorectal cancer
Read the detailed description
The purpose of the study is to evaluate the efficacy and safety of first-line single-agent panitumumab in frail elderly patients with advanced Wild Type K-RAS colorectal cancer
- Conditions
- Colorectal Cancer
- Being tested
- Panitumumab
- Keywords
- advanced colorectal cancer; K-RAS; panitumumab, advanced Wild Type K-RAS colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabBiological
Panitumumab: 6 mg/Kg Q2W
| Study group | Role | What they receive |
|---|---|---|
| Panitumumab | Experimental | Panitumumab: 6 mg/Kg Q2W Treatment cycles repeated every 14 days. Subjects will be evaluated for tumour response every 3 cycles (6 wks ± 1 wk) the first 24 weeks and every 8 weeks ± 2 weeks thereafter (per the revised-RECIST 1.1 guideline) until PD or withdrawal from the trial. Receives: Biological: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate at 6 months
Measured: May 2010 - March 2012
Secondary outcomes (12)
Progression-free survival
Measured: May 2010 - March 2012
Objective Response Rate
Measured: May 2010 - March 2012
Disease control rate
Measured: May 2010 - March 2012
Time to response
Measured: May 2010 - March 2012
Time to progression
Measured: May 2010 - March 2012
Time to treatment failure
Measured: May 2010 - March 2012
Duration of response
Measured: May 2010 - March 2012
Duration of stable disease
Measured: May 2010 - March 2012
Overall survival
Measured: May 2010 - March 2012
Changes in patient-reported outcomes
Measured: May 2010 - March 2012
Adverse events
Measured: May 2010 - March 2012
Evaluation of molecular predictive markers for response.
Measured: May 2010 - March 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Javier Sastre, Study chair, Hospital Universitario Clínico San Carlos. Madrid. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126112
- Sponsor's protocol ID
- TTD-09-03
- Other IDs
- 2009-016661-28, 2009
- Acronym
- FRAIL
- Status last verified
- Mar 2015
- First submitted
- 17 May 2010
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sastre J, Massuti B, Pulido G, Guillen-Ponce C, Benavides M, Manzano JL, Reboredo M, Rivera F, Gravalos C, Safont MJ, Martinez Villacampa M, Llovet P, Dotor E, Diaz-Rubio E, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumours TTD. First-line single-agent panitumumab in frail elderly patients with wild-type KRAS metastatic colorectal cancer and poor prognostic factors: A phase II study of the Spanish Cooperative Group for the Treatment of Digestive Tumours. Eur J Cancer. 2015 Jul;51(11):1371-80. doi: 10.1016/j.ejca.2015.04.013. Epub 2015 May 8.
PubMed 25963019
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-RAS Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01126112
- Acronym / sponsor ID
- FRAIL / TTD-09-03
- Conditions
- Colorectal Cancer
- Keywords
- advanced colorectal cancer; K-RAS; panitumumab, advanced Wild Type K-RAS colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)University, hospital or other
- Collaborators
- Amgen
- Study start
- May 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 May 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 purpose of the study is to evaluate the efficacy and safety of first-line single-agent panitumumab in frail elderly patients with advanced Wild Type K-RAS colorectal cancer
Detailed description
The purpose of the study is to evaluate the efficacy and safety of first-line single-agent panitumumab in frail elderly patients with advanced Wild Type K-RAS colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Panitumumab | Experimental | Biological: PanitumumabPanitumumab: 6 mg/Kg Q2W Treatment cycles repeated every 14 days. Subjects will be evaluated for tumour response every 3 cycles (6 wks ± 1 wk) the first 24 weeks and every 8 weeks ± 2 weeks thereafter (per the revised-RECIST 1.1 guideline) until PD or withdrawal from the trial. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (18 listed)
- Signed Inform Consent
- Age > 70 years.
- Histologically documented metastatic colorectal cancer not candidate for surgical resection
- Wild type K-RAS
- Measurable disease by RECIST Criteria
Key exclusion criteria (16 listed)
- Patients will be excluded from the study if they have received prior systemic therapy for the treatment of metastatic colorectal carcinoma or antiEGFR therapy, with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to enrolment or oxaliplatin at least 12 months prior to enrolment.
- Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before inclusion
- Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion
- Patients cognitively impaired or with severe depression according mini mental state examination and geriatric depression scale.
- Patients with central nervous system metastases, or those with significant cardiovascular disease, will also be excluded.
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 |
|---|---|---|
| PanitumumabPanitumumab: 6 mg/Kg Q2W | Biological | Panitumumab |
Primary outcome
Progression-free survival rate at 6 months
Time frame: May 2010 - March 2012
12 secondary outcomes
Progression-free survival
Time frame: May 2010 - March 2012
Objective Response Rate
Time frame: May 2010 - March 2012
Disease control rate
Time frame: May 2010 - March 2012
Time to response
Time frame: May 2010 - March 2012
Time to progression
Time frame: May 2010 - March 2012
Time to treatment failure
Time frame: May 2010 - March 2012
Duration of response
Time frame: May 2010 - March 2012
Duration of stable disease
Time frame: May 2010 - March 2012
Overall survival
Time frame: May 2010 - March 2012
Changes in patient-reported outcomes
Time frame: May 2010 - March 2012
Adverse events
Time frame: May 2010 - March 2012
Evaluation of molecular predictive markers for response.
Time frame: May 2010 - March 2012
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 24 Mar 2015.
- Derived from this study: PubMed 25963019Sastre J, Massuti B, Pulido G, Guillen-Ponce C, Benavides M, Manzano JL, Reboredo M, Rivera F, Gravalos C, Safont MJ, Martinez Villacampa M, Llovet P, Dotor E, Diaz-Rubio E, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumours TTD. First-line single-agent panitumumab in frail elderly patients with wild-type KRAS metastatic colorectal cancer and poor prognostic factors: A phase II study of the Spanish Cooperative Group for the Treatment of Digestive Tumours. Eur J Cancer. 2015 Jul;51(11):1371-80. doi: 10.1016/j.ejca.2015.04.013. Epub 2015 May 8.
- Related InfoLink provided by the sponsor.
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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.
Javier Sastre study chair
Hospital Universitario Clínico San Carlos. Madrid. Spain
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 Panitumumab in people with Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
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 18 inclusion and 16 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 24 Mar 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 Spain. 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?
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?
Progression-free survival rate at 6 months (time frame: May 2010 - March 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01126112, which also lists 1 linked publication.
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 24 Mar 2015.