Metastatic Colorectal CancerPhase 2PACERNCT01801904
A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer
A Phase 2 study testing Panitumumab in people with Metastatic Colorectal Cancer, run by National Cancer Institute, Naples at 5 sites in Italy.
Trial summary
The purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab. 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?
- Panitumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 5 sitesItaly
- Study dates
- Dec 2012to Dec 2024
- 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
- Pathologic diagnosis of metastatic colorectal adenocarcinoma
- a wild-type RAS tumor (mutational status has to be determined by an experienced laboratory using validated test methods for detection of KRAS exons 2, 3, and 4, and NRAS exons 2, 3, and 4
- Failure from previous treatment with fluoropyrimidine, oxaliplatin and irinotecan. Patients may or may not have been treated with bevacizumab.
- Documented disease progression following a treatment with cetuximab in patients who showed either an objective response after 8 weeks or stable disease after 16 weeks of cetuximab treatment.
- Age at least 18 years
- ECOG Performance Status 0-2
Show all 13Show fewer
- Neutrophils at least 1,500 mm3, platelets at least 100,000 mm3, and hemoglobin at least 9 g/dL
- Bilirubin level less than 1.5 times ULN
- AST (SGOT) and ALT (SGPT) not greater than 2.5 times ULN (or 5 times ULN in presence of liver metastasis)
- Serum creatinine less than 1.5 times ULN
- Effective contraception, if the risk of conception exists
- Life expectancy at least 3 months
- Written informed consent
Who cannot join
- Symptomatic brain metastasis
- Interstitial pneumonitis or pulmonary fibrosis
- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
- Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks
- Any unstable systemic disease (including active infections, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study drugs or render the patient at high risk from treatment complications
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Azienda Ospedaliera G. Rummo
Benevento, BN
Ospedale Fatebenefratelli
Benevento
A.O.U. Policlinico Federico II
Naples
Istituto Nazionale dei Tumori
Naples
Casa Sollievo Sofferenza
S. Giovanni Rotondo
About this study
The purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.
Read the detailed description
The study was amended with modification of inclusion criteria (from wild-type tumor KRAS gene to wild-type RAS gene, including KRAS and NRAS exons 2, 3 and 4)
RAS mutational status of tumors of patients enrolled before amendment 1 approval will be centrally revised. Patients whose tumors will result RAS mutated at the biomarkers central revision, will be replaced. Therefore, the overall sample size at both the stages may be higher than the one initially planned.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Panitumumab
- Keywords
- cetuximab-refractory
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
6mg/kg IV given every 2 weeks until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Panitumumab | Experimental | Not described Receives: Drug: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients alive and without disease progression
progression of disease within 2 months from registration according to RECIST criteria, and death for any cause within 2 months from registration
Measured: 2 months
Secondary outcomes (4)
response rate
Response assessed per patients at weeks 8,16,24,32,40 and every 3 months thereafter, using RECIST criteria
Measured: up to 40 weeks
progression free survival
Measured: 9 months
overall survival
Measured: one year
worst grade toxicity per patient
worst grade toxicity (according to Common Terminology Criteria for Adverse Events version 3) per patient
Measured: every 2 weeks for up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
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 Metastatic 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera G. Rummo
- Responsible party
- Sponsor
- Investigators
- Bruno Daniele, M.D., Principal investigator, Azienda Sanitaria Rummo, Benevento, Division of Medical OncologyFrancesco Perrone, M.D., Ph.D, Principal investigator, National Cancer Institute Naples, Italy; Director Clinical Trials UnitCiro Gallo, M.D., Ph.D, Principal investigator, Second University of Naples, Italy; Chair of Medical StatisticsAntonio Gasbarrini, M.D., Principal investigator, Università Cattolica del S. Cuore, Policlinico Gemelli, RomaGiacomo Carteni', M.D., Principal investigator, Ospedale Antonio Cardarelli, Napoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801904
- Sponsor's protocol ID
- PACER
- Other IDs
- 2010-024490-39
- Acronym
- PACER
- Status last verified
- Mar 2023
- First submitted
- 15 Jan 2013
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Piccirillo MC, Avallone A, Carlomagno C, Maiello E, Rosati G, Alabiso O, Nasti G, De Placido S, Latiano TP, Bilancia D, Ottaiano A, De Stefano A, Romano C, Silvestro L, Nappi A, Cassata A, Giordano P, Iaffaioli RV, Normanno N, Perrone F, Daniele B. Multicenter Single-Arm, Two-Stage Phase 2 Study of Panitumumab in Patients With Cetuximab-Refractory Metastatic Colorectal Cancer: The PACER Trial. Clin Colorectal Cancer. 2020 Dec;19(4):270-276. doi: 10.1016/j.clcc.2020.05.009. Epub 2020 May 29.
PubMed 32631788
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01801904
- Acronym / sponsor ID
- PACER / PACER
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- cetuximab-refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera G. Rummo
- Study start
- Dec 2012
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Mar 2013 (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 this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.
Detailed description
The study was amended with modification of inclusion criteria (from wild-type tumor KRAS gene to wild-type RAS gene, including KRAS and NRAS exons 2, 3 and 4)
RAS mutational status of tumors of patients enrolled before amendment 1 approval will be centrally revised. Patients whose tumors will result RAS mutated at the biomarkers central revision, will be replaced. Therefore, the overall sample size at both the stages may be higher than the one initially planned.
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 | Drug: Panitumumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pathologic diagnosis of metastatic colorectal adenocarcinoma
- a wild-type RAS tumor (mutational status has to be determined by an experienced laboratory using validated test methods for detection of KRAS exons 2, 3, and 4, and NRAS exons 2, 3, and 4
- Failure from previous treatment with fluoropyrimidine, oxaliplatin and irinotecan. Patients may or may not have been treated with bevacizumab.
- Documented disease progression following a treatment with cetuximab in patients who showed either an objective response after 8 weeks or stable disease after 16 weeks of cetuximab treatment.
- Age at least 18 years
Key exclusion criteria (6 listed)
- Symptomatic brain metastasis
- Interstitial pneumonitis or pulmonary fibrosis
- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
- Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks
- Any unstable systemic disease (including active infections, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study drugs or render the patient at high risk from treatment complications
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 |
|---|---|---|
| Panitumumab6mg/kg IV given every 2 weeks until disease progression or unacceptable toxicity | Drug | Panitumumab |
Primary outcome
number of patients alive and without disease progression
Time frame: 2 months
progression of disease within 2 months from registration according to RECIST criteria, and death for any cause within 2 months from registration
4 secondary outcomes
response rate
Time frame: up to 40 weeks
progression free survival
Time frame: 9 months
overall survival
Time frame: one year
worst grade toxicity per patient
Time frame: every 2 weeks for up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 32631788Piccirillo MC, Avallone A, Carlomagno C, Maiello E, Rosati G, Alabiso O, Nasti G, De Placido S, Latiano TP, Bilancia D, Ottaiano A, De Stefano A, Romano C, Silvestro L, Nappi A, Cassata A, Giordano P, Iaffaioli RV, Normanno N, Perrone F, Daniele B. Multicenter Single-Arm, Two-Stage Phase 2 Study of Panitumumab in Patients With Cetuximab-Refractory Metastatic Colorectal Cancer: The PACER Trial. Clin Colorectal Cancer. 2020 Dec;19(4):270-276. doi: 10.1016/j.clcc.2020.05.009. Epub 2020 May 29.
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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.
Bruno Daniele, M.D. principal investigator
Azienda Sanitaria Rummo, Benevento, Division of Medical Oncology
Francesco Perrone, M.D., Ph.D principal investigator
National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Ciro Gallo, M.D., Ph.D principal investigator
Second University of Naples, Italy; Chair of Medical Statistics
5 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 Panitumumab in people with Metastatic Colorectal Cancer, run by National Cancer Institute, Naples at 5 sites in Italy.
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 6 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 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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?
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?
number of patients alive and without disease progression (time frame: 2 months). 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 NCT01801904, 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 2023.