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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02296203
Recruitment Status : Unknown
Verified February 2018 by Gruppo Oncologico del Nord-Ovest.
Recruitment status was:  Active, not recruiting
First Posted : November 20, 2014
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Oncologico del Nord-Ovest

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: cetuximab Drug: irinotecan Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2014
Actual Primary Completion Date : June 19, 2017
Estimated Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: cetuximab and irinotecan Drug: cetuximab
Drug: irinotecan


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296203


Locations
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Italy
AUSL DI FROSINONE - FROSINONE (FR) ONCOLOGIA MEDICA U.O. Oncologia Medica
Frosinone, Italy, 03100
Irccs Istituto Oncologico Veneto (Iov) - Padova (Pd) Oncologia Medica
Padova, Italy, 35128
Azienda Ospedaliero Universitaria Di Parma - U.O.Oncologia Medica
Parma, Italy
A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica
Pisa, Italy, 56126
AUSL 5 DI PISA - PISA (PI) ONCOLOGIA MEDICA oncologia medica Osp Lotti Pontedera
Pontedera, Italy, 56100
Ospedale Fatebenefratelli
Roma, Italy, 00186
Azienda Policlinico Umberto I - Oncologia Medica
Roma, Italy
Campus Biomedico
Roma, Italy
A.O. Universitaria S.Maria Della Misericordia Di Udine
Udine, Italy, 33100
Sponsors and Collaborators
Gruppo Oncologico del Nord-Ovest
Investigators
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Principal Investigator: Alfredo Falcone, MD, PhD U.O. Oncologia Medica 2 Universitaria, Università di Pisa - AOUP, Polo Oncologico, Area Vasta Nord-Ovest, Istituto Toscano Tumori
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gruppo Oncologico del Nord-Ovest
ClinicalTrials.gov Identifier: NCT02296203    
Other Study ID Numbers: GONO 10
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Keywords provided by Gruppo Oncologico del Nord-Ovest:
cetuximab rechallenge
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Irinotecan
Cetuximab
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological