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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study

NCT02316496

Colorectal Cancer Metastatic

TERMINATED PHASE2

Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions

NCT00637091

Advanced Colorectal Cancer

COMPLETED PHASE2

Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer

NCT00063141

Colorectal Cancer

COMPLETED PHASE3

A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma

NCT00362102

Colorectal Carcinoma

COMPLETED PHASE2

Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy

NCT00336856

Colon Cancer Rectum Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cetuximab and irinotecan

Group Type EXPERIMENTAL

cetuximab

Intervention Type DRUG

irinotecan

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cetuximab

Intervention Type DRUG

irinotecan

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No