Observational Study on Second Line Treatment of Liver Metastases With DEBIRI and Cetuximab

Colon Cancer Liver Metastasis Clinical Trial

— TACETUX  

Official title:

Observational Study on Second Line Treatment of Colorectal Liver Metastases (KRas wt) by Hepatic Intra-arterial Chemoembolization With Dc Beads 70-150 μm Microspheres Preloaded With Irinotecan 200 Mgr Plus Systemic Cetuximab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891552
• Other study ID #: TACETUX01
• Status: Completed
• Phase: N/A
• First received: June 26, 2013
• Last updated: May 12, 2015
• Start date: May 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: International Group of Endovascular Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

• The recently introduced chemoembolization has been considered to be a very attractive new method in terms of response in the treatment of liver metastases from colon cancer carcinoma (LM-CRC). It appears to be particularly useful if carried out with the new embolization materials.

• An 80% response rate was reported using TACE with Irinotecan pre-loaded Beads in patients with liver metastases from colon cancer, who had been pretreated with 2 or more lines of chemotherapy.

• Since a greater activity was attained by a combination of Cetuximab and Irinotecan versus Cetuximab in monotherapy, the European Agency for the Evaluation of Medicinal Products (EMEA) has granted authorization to the use of Cetuximab in association with irinotecan in the treatment of irinotecan-refractory CRC-LM.

• In this study we want to collect data on on time to progression and tolerability using DEBIRI+Cetuximab in LM-CRC

Description:

This is an observational study and the treatment is related to the experiences and economical availability of each center.

Primary objective: To collect data on time to progression (local and/or distant progression) after administration of Dc-Beads microspheres preloaded with Irinotecan 200 mgr via hepatic intra-arterial locoregional delivery (TACE) in/without association with standard weekly therapy with Cetuximab.

Secondary objectives: To collect data on tolerability of treatment and improvement of quality of life (Edmonton Symptom Assessment System (ESAS))

Treatment under observation :

Program A ( for all patients)

Day +1:

Lobar Infusion (lobe with dominant disease) of Irinotecan 100 mg preloaded into 2 ml of 70-150 µm M1 microspheres.

Second lobar infusion of Irinotecan 100 mg preloaded into 2 ml of 70-150 µm M1 microspheres can be administered at the same time contralaterally or in a further TACE.

Day +30: The above procedure is repeated. Day +90: In case of response, a third administration following the above procedures will be repeated

Program B ( for Centers in which Cetuximab is available) 5.2 Cetuximab administered as per standard scheme: Day -15: loading dose with 400 mg/mq i.v. over a 2-hour period Day +21 and subsequent weekly administrations: 250 mg/mq i.v. over a one hour period.

It is pointed out that administration of Cetuximab will be continued following the timeline of the first infusion relative to the intra-arterial administration.

Evaluation of response

Response must be assessed by repeating the following examinations at Day 30, Day 90 and Day 120 after start of treatment:

Chest-abdomen CAT scan with and without contrast medium (refer to Section 4). Evaluation will be based on the Response Evaluation Criteria In Solid Tumors (RECIST) cancer markers (CEA, Carbohydrate Antigen (CA) 19.9)

Assessment of quality of life The Edmonton Symptom Assessment System (ESAS) is used to monitor health conditions and quality of life.

The questionnaire must be filled in by the patient unaided by family members or by health care personnel, over a period of about 15 minutes. Assessment of quality of life will be performed during the baseline visit and at Day 30, Day 60 and Day 120 from start of treatment.

It is important for the questionnaire to be completed by the patient before undergoing the physical examination, in other words before discussing with the physician about any examinations which might give an indication of the favorable or unfavorable course of the disease. In providing the questionnaire to the patient, the physician will explain how to complete it without discussing the contents of the questions, and once the patient has completed the questionnaire, the physician will check that all questions have been answered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Unresectable hepatic metastases from colorectal carcinoma (CRC-LM)

2. Progression of disease after first line therapy containing Irinotecan completed at least one month previously

3. Performance status (PS) 0-2

4. Biochemistry parameters within normal limits (ALT and gamma glutamyl transpeptidase not exceeding three times the upper limit of normal, total bilirubin not exceeding 2.5 mg/ml)

5. Adequate information and subsequent written informed consent

6. Life expectancy > 3 months

7. Patients K-RAS wild type

Exclusion Criteria:

1. Extension of disease greater than 50% of the parenchymal liver (confirmed by CAT scan or MRI)

2. Brain metastases

3. Severe and confirmed vascular diseases

4. Other concomitant malignancies except for cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix

5. Evidence of significant diseases such as uncontrolled diabetes, congestive heart failure, chronic renal insufficiency (CRI)

6. Known hypersensitivity reactions towards components of the study drugs

7. Pregnant or breastfeeding women or women of childbearing potential not making use of effective contraceptives

8. Family, psychological, social or geographical circumstances preventing the patient from undergoing follow-up and from complying with protocol procedures

9. Patients K-RAS mutant

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Cancer Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore	Pesaro	PU

Sponsors (1)

Lead Sponsor	Collaborator
International Group of Endovascular Oncology

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Fiorentini G, Aliberti C, Tilli M, Mulazzani L, Graziano F, Giordani P, Mambrini A, Montagnani F, Alessandroni P, Catalano V, Coschiera P. Intra-arterial infusion of irinotecan-loaded drug-eluting beads (DEBIRI) versus intravenous therapy (FOLFIRI) for he — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	quality of life		4 months	No
Primary	time to progression		one year	No
Secondary	number of adverse events		4 months	Yes

External Links

•   International group of endovascular oncology (IGEVO) website