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Metastatic Colorectal CancerPhase 2CRICKETNCT02296203

Cetuximab Rechallenge in Irinotecan-pretreated mCRC, KRAS, NRAS and BRAF Wild-type Treated in 1st Line With Anti-EGFR Therapy (CRICKET).

A Phase 2 study testing cetuximab and irinotecan in people with Metastatic Colorectal Cancer, run by Gruppo Oncologico del Nord-Ovest at 9 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multicentric, phase II single-arm study in which KRAS, NRAS and BRAF wild-type, irinotecan-resistant metastatic colorectal cancer patients progressing after an initial response to a first-line cetuximab-containing therapy, receive a rechallenge third-line treatment with cetuximab plus irinotecan. 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 and irinotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
9 sitesItaly
Study dates
Oct 2014to 15 Jun 2018
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

  • Histologically proven diagnosis of colorectal adenocarcinoma;
  • RAS and BRAF wild-type status;
  • First-line irinotecan-based (FOLFIRI or FOLFOXIRI) cetuximab-containing therapy producing at least a partial response;
  • First-line progression-free survival in response to cetuximab-containing therapy ≥6 months;
  • Documentation of progression to first-line cetuximab within 4 weeks after last cetuximab administration;
  • Time between the end of first-line therapy and the start of third-line treatment with cetuximab plus irinotecan ≥4 months;
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  • Second-line oxaliplatin-based (FOLFOXIRI, FOLFOX or XELOX) bevacizumab-containing therapy;
  • Documentation of progression to second-line treatment;
  • Measurable disease according to RECIST criteria v1.1;
  • Have tumor tissue (of primary tumor and metastases or at least one of the two) available for biomarker analysis;
  • Male or female patients > 18 years of age;
  • ECOG Performance Status ≤ 2;
  • Life expectancy of at least 3 months;
  • Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment;
  • Women of childbearing potential must have a negative blood pregnancy test at the baseline visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile or are sexually inactive;
  • Subjects and their partners must be willing to avoid pregnancy during the trial and until 6 months after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as approved by the investigator, such as a two-barrier method or one-barrier method with spermicidal or intrauterine device. This requirement begins 2 weeks before receiving the first trial treatment and ends 6 months after receiving the last treatment;
  • Signed informed consent obtained before any study specific procedure.

Who cannot join

  • Active uncontrolled infections or active disseminated intravascular coagulation;
  • Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix;
  • Fertile women (< 12 months after last menstruation) and men of childbearing potential not willing to use effective means of contraception
  • Women who are pregnant or are breastfeeding;
  • Previous grade 3/4 infusion related reaction to cetuximab.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Italy9 sites

  • AUSL DI FROSINONE - FROSINONE (FR) ONCOLOGIA MEDICA U.O. Oncologia Medica

    Frosinone, 03100

  • Irccs Istituto Oncologico Veneto (Iov) - Padova (Pd) Oncologia Medica

    Padova, 35128

  • Azienda Ospedaliero Universitaria Di Parma - U.O.Oncologia Medica

    Parma

  • A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica

    Pisa, 56126

  • AUSL 5 DI PISA - PISA (PI) ONCOLOGIA MEDICA oncologia medica Osp Lotti Pontedera

    Pontedera, 56100

  • Ospedale Fatebenefratelli

    Roma, 00186

  • Azienda Policlinico Umberto I - Oncologia Medica

    Roma

  • Campus Biomedico

    Roma

  • A.O. Universitaria S.Maria Della Misericordia Di Udine

    Udine, 33100

Other trials in Italy

About this study

Official title: A PHASE II SINGLE-ARM STUDY OF CETUXIMAB PLUS IRINOTECAN AS RECHALLENGE 3RD-LINE TREATMENT OF KRAS, NRAS AND BRAF WILD-TYPE IRINOTECAN-PRETREATED METASTATIC COLORECTAL CANCER PATIENTS PROGRESSING AFTER AN INITIAL RESPONSE TO A 1ST-LINE CETUXIMAB-CONTAINING THERAPY AND A STANDARD 2ND-LINE

This is a multicentric, phase II single-arm study in which KRAS, NRAS and BRAF wild-type, irinotecan-resistant metastatic colorectal cancer patients progressing after an initial response to a first-line cetuximab-containing therapy, receive a rechallenge third-line treatment with cetuximab plus irinotecan.

Being tested
cetuximab, irinotecan
Keywords
cetuximab rechallenge
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02296203
Study groupRoleWhat they receive
cetuximab and irinotecanExperimentalNot described
Receives: Drug: cetuximab; Drug: irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. percentage of patients achieving a decrease equal or more than 30% in the sum of the longest diameters of target lesions

    ORR is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria. The determination of clinical response will be based on investigator-reported measurements. Responses will be evaluated with a chest and abdominal computed tomography (CT) scan every 8 weeks. Patients who do not have an on-study assessment will be included in the analysis as non-responders.

    Measured: evaluation every 8 weeks until 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2014 (estimated)
  2. Study startOct 2014
  3. Primary completion19 Jun 2017
  4. Study completion15 Jun 2018 (estimated)

Resources

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02296203
Sponsor's protocol ID
GONO 10
Acronym
CRICKET
Status last verified
Feb 2018
First submitted
15 Oct 2014
Last updated
15 Feb 2018
Results posted
No

Publications

  • Ciardiello D, Martinelli E, Troiani T, Mauri G, Rossini D, Martini G, Napolitano S, Famiglietti V, Del Tufo S, Masi G, Santini D, Avallone A, Pietrantonio F, Lonardi S, Di Maio M, Zampino MG, Fazio N, Bardelli A, Siena S, Cremolini C, Sartore-Bianchi A, Ciardiello F. Anti-EGFR Rechallenge in Patients With Refractory ctDNA RAS/BRAF wt Metastatic Colorectal Cancer: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Apr 1;7(4):e245635. doi: 10.1001/jamanetworkopen.2024.5635.

    PubMed 38592721

  • Martini G, Ciardiello D, Famiglietti V, Rossini D, Antoniotti C, Troiani T, Napolitano S, Esposito L, Latiano TP, Maiello E, Del Re M, Lonardi S, Aprile G, Santini D, Masi G, Avallone A, Normanno N, Pietrantonio F, Pinto C, Ciardiello F, Cremolini C, Martinelli E. Cetuximab as third-line rechallenge plus either irinotecan or avelumab is an effective treatment in metastatic colorectal cancer patients with baseline plasma RAS/BRAF wild-type circulating tumor DNA: Individual patient data pooled analysis of CRICKET and CAVE trials. Cancer Med. 2023 Apr;12(8):9392-9400. doi: 10.1002/cam4.5699. Epub 2023 Mar 7.

    PubMed 36880426

  • Cremolini C, Rossini D, Dell'Aquila E, Lonardi S, Conca E, Del Re M, Busico A, Pietrantonio F, Danesi R, Aprile G, Tamburini E, Barone C, Masi G, Pantano F, Pucci F, Corsi DC, Pella N, Bergamo F, Rofi E, Barbara C, Falcone A, Santini D. Rechallenge for Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer With Acquired Resistance to First-line Cetuximab and Irinotecan: A Phase 2 Single-Arm Clinical Trial. JAMA Oncol. 2019 Mar 1;5(3):343-350. doi: 10.1001/jamaoncol.2018.5080.

    PubMed 30476968

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab and irinotecan in people with Metastatic Colorectal Cancer, run by Gruppo Oncologico del Nord-Ovest at 9 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 17 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: status not confirmed, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

percentage of patients achieving a decrease equal or more than 30% in the sum of the longest diameters of target lesions (time frame: evaluation every 8 weeks until 48 weeks). 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 NCT02296203, which also lists 3 linked publications.

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 15 Feb 2018.

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