search
Back to results

Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab.

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Cetuximab
FOLFIRI
Sponsored by
Regione Lombardia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Neoplasms, KRAS, PTEN

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Signed written informed consent for biological analysis (all pts)
  • Signed written informed consent for enrolment (pts with KRAS wild type)
  • Male or female aged > or = 18 years
  • Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
  • KRAS evaluation availability with wild-type result
  • Metastatic CRC not suitable for curative-intent resection
  • Availability of tumour samples (or able and willing to provide tumour sample) and blood for biological analysis
  • Presence of at least one lesion measurable unidimensionally by computed tomography (CT) scan or magnetic resonance imaging (MRI). (index lesion(s) must not lie within an irradiated area)
  • Eastern cooperative oncology group-performance status (ECOG-PS) <2

Exclusion criteria

  • Brain metastasis (known or suspected)
  • Previous chemotherapy for metastatic CRC (any). Adjuvant therapy is allowed if the chemotherapy treatment free interval is > 6 months
  • Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
  • Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
  • Any investigational agent(s) within 4 weeks prior to entry
  • Previous exposure to HER-axis -pathway targeting therapy
  • Leucocytes <3.0 x 109/L and neutrophils <1.5 x 109/L, platelets <100 x 109/L, and hemoglobin <9 g/dL
  • Bilirubin level either normal or >1.5 x ULN
  • ASAT and ALAT >2.5 x ULN (>5 x ULN if liver metastasis are present)
  • Serum creatinine >1.5 x ULN
  • Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
  • Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
  • Pre-existing neuropathy > grade 1
  • Known grade 3 or 4 allergic reaction to any of the components of the treatment
  • Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Pts with a previous malignancy but without evidence of disease for > or equal 5 years will be allowed to enter the trial)
  • Pregnancy or lactation
  • Inadequate contraception (male or female pts) if of childbearing or procreational potential
  • Known drug abuse/ alcohol abuse
  • Legal incapacity or limited legal capacity
  • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

Sites / Locations

  • Ospedale di Treviglio e Caravaggio
  • Istututo Clinico Humanitas
  • Ospedale Morelli Sondalo
  • Ospedale di Saronno
  • Ospedali Riuniti di Bergamo
  • IRCCS San Raffaele
  • Ospedale di Sondrio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Cetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1, followed after 1 hour by FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival

Full Information

First Posted
May 4, 2009
Last Updated
May 9, 2014
Sponsor
Regione Lombardia
Collaborators
Mario Negri Institute for Pharmacological Research, Istituto Clinico Humanitas, A.O. Ospedale Papa Giovanni XXIII
search

1. Study Identification

Unique Protocol Identification Number
NCT01068132
Brief Title
Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab.
Official Title
Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab. An Italian Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regione Lombardia
Collaborators
Mario Negri Institute for Pharmacological Research, Istituto Clinico Humanitas, A.O. Ospedale Papa Giovanni XXIII

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Italian, multicentre, non comparative trial in patients with advanced Colorectal Cancer(CRC)and KRAS wild-type, defined by molecular evaluation. Patients will receive Cetuximab + FOLFIRI until disease progression, unacceptable toxicity developed or patient refusal. The aim of this study is to assess the prognostic role of PTEN in terms of Progression free survival. Although the role of Cetuximab as first line treatment in metastatic CRC will be soon established, it is still unclear which is the best schedule for Cetuximab and the role of biological factors in order to select the most appropriate subset of pts for recommending Cetuximab. The data supporting a benefit of Cetuximab in KRAS wild-type pts open the perspective to study the role of other molecular markers in this subset of pts. On the basis of these considerations this study is aimed at testing a different schedule of Cetuximab and better characterize the prognosis of pts for which Cetuximab is appropriate.
Detailed Description
Pts meeting eligibility criteria will be registered, providing the availability of material for molecular analysis. Tumour specimens and blood sample will be collected to perform genomic, ICH and proteomic analyses in order to identify the molecular characteristics of tumour. After the availability of KRAS evaluation, only the data of KRAS wild-type pts will be collected. Access to registration system will be allowed via web. Patients,KRAS wild-type receive: - Cetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1, followed after 1 hour by FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Neoplasms, KRAS, PTEN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1, followed after 1 hour by FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1,
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
untill 48 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
untill 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Signed written informed consent for biological analysis (all pts) Signed written informed consent for enrolment (pts with KRAS wild type) Male or female aged > or = 18 years Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum KRAS evaluation availability with wild-type result Metastatic CRC not suitable for curative-intent resection Availability of tumour samples (or able and willing to provide tumour sample) and blood for biological analysis Presence of at least one lesion measurable unidimensionally by computed tomography (CT) scan or magnetic resonance imaging (MRI). (index lesion(s) must not lie within an irradiated area) Eastern cooperative oncology group-performance status (ECOG-PS) <2 Exclusion criteria Brain metastasis (known or suspected) Previous chemotherapy for metastatic CRC (any). Adjuvant therapy is allowed if the chemotherapy treatment free interval is > 6 months Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol Any investigational agent(s) within 4 weeks prior to entry Previous exposure to HER-axis -pathway targeting therapy Leucocytes <3.0 x 109/L and neutrophils <1.5 x 109/L, platelets <100 x 109/L, and hemoglobin <9 g/dL Bilirubin level either normal or >1.5 x ULN ASAT and ALAT >2.5 x ULN (>5 x ULN if liver metastasis are present) Serum creatinine >1.5 x ULN Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease Pre-existing neuropathy > grade 1 Known grade 3 or 4 allergic reaction to any of the components of the treatment Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Pts with a previous malignancy but without evidence of disease for > or equal 5 years will be allowed to enter the trial) Pregnancy or lactation Inadequate contraception (male or female pts) if of childbearing or procreational potential Known drug abuse/ alcohol abuse Legal incapacity or limited legal capacity Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Labianca, MD
Organizational Affiliation
A.O. Ospedale Papa Giovanni XXIII
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Armando Santoro, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale di Treviglio e Caravaggio
City
Treviglio
State/Province
Bergamo
ZIP/Postal Code
24047
Country
Italy
Facility Name
Istututo Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20086
Country
Italy
Facility Name
Ospedale Morelli Sondalo
City
Sondalo
State/Province
Sondrio
ZIP/Postal Code
23035
Country
Italy
Facility Name
Ospedale di Saronno
City
Saronno
State/Province
Varese
ZIP/Postal Code
21047
Country
Italy
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
IRCCS San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Ospedale di Sondrio
City
Sondrio
ZIP/Postal Code
23100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab.

We'll reach out to this number within 24 hrs