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Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status

Terminated

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Irinotecan

Avastin

Erbitux

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Metastatic colorectal cancer, Second line, Irinotecan, Erbitux (Cetuximab), Avastin (Bevacizumab)

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed locally advanced or metastatic colorectal cancer.
Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
ECOG performance status ≤ 2
Age 18 - 72 years
Patients with de novo refractory disease (progression of disease as best response at 1st line therapy with FOLFOX/Avastin)
Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL),renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function
Patients must be able to understand the nature of this study
Written informed consent

Exclusion Criteria:

History of serious cardiac disease (unstable angina, congestive heart failure, uncontrolled cardiac arrhythmias).
History of myocardial infarction or stroke within 6 months.
Clinically significant peripheral vascular disease.
History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0.
Presence of central nervous system or brain mets.
Evidence of bleeding diathesis or coagulopathy.
Patients with known hypersensitive reaction to cetuximab
Blood pressure > 150/100 mmHg.
Pregnant or lactating woman.
Life expectancy < 3 months.
Previous radiotherapy within the last 4 weeks or > 25% of bone marrow.
Metastatic infiltration of the liver >50%.
Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy.
Active infection requiring antibiotics on Day 1.
Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
Psychiatric illness or social situation that would preclude study compliance.

Sites / Locations

University General Hospital of Alexandroupolis, Dep of Medical Oncology
401 Military Hospital of Athens
: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Air Forces Military Hospital of Athens
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
State General Hospital of Larissa
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Irinotecan+Avastin+Erbitux

Outcomes

Primary Outcome Measures

Time To Progression

Secondary Outcome Measures

Objective Response Rate

Toxicity profile

Quality of life, Symptoms improvement

Full Information

NCT ID

NCT00681876

First Posted

May 19, 2008

Last Updated

February 12, 2013

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

1. Study Identification

Unique Protocol Identification Number

NCT00681876

Brief Title

Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer

Official Title

Phase II Study of Avastin Plus Erbitux Plus Irinotecan as 2nd Line Treatment of Locally Advanced or Metastatic Colorectal Cancer in Patients Achieving Disease Progression as Best Response After 1st Line Treatment With FOLFIRI+Avastin or XELIRI+Avastin

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Terminated

Why Stopped

Due to poor accrual

Study Start Date

April 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This phase II study will evaluate the efficacy of the combination of two monoclonal antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin.

Detailed Description

Treating patients with primary resistance to the most active multi-agent combination remains a challenging clinical problem. The reported data demonstrated that addition of ERBITUX may reverse IRINOTECAN resistance. Further data support the feasibility of the combination of two monoclonal antibodies (AVASTIN+ERBITUX) with IRINOTECAN with better responses compared to historical controls (ERBITUX±IRINOTECAN). As such, a phase II study was designed to evaluate the efficacy of the combination of AVASTIN plus ERBITUX plus IRINOTECAN as second line treatment in patients progressing while on treatment with FOLFIRI AVASTIN or XELIRI AVASTIN

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

Metastatic colorectal cancer, Second line, Irinotecan, Erbitux (Cetuximab), Avastin (Bevacizumab)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Irinotecan+Avastin+Erbitux

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Other Intervention Name(s)

CPT-11, Campto

Intervention Description

Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression

Intervention Type

Drug

Intervention Name(s)

Avastin

Other Intervention Name(s)

Bevacizumab

Intervention Description

Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression

Intervention Type

Drug

Intervention Name(s)

Erbitux

Other Intervention Name(s)

Cetuximab

Intervention Description

Erbitux (IV)500 mg/m2 on day 1 every two weeks until progression

Primary Outcome Measure Information:

Title

Time To Progression

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Objective Response Rate

Time Frame

Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Title

Toxicity profile

Time Frame

Toxicity assessment on each chemotherapy cycle

Title

Quality of life, Symptoms improvement

Time Frame

Assessment every two cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed locally advanced or metastatic colorectal cancer. Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) ECOG performance status ≤ 2 Age 18 - 72 years Patients with de novo refractory disease (progression of disease as best response at 1st line therapy with FOLFOX/Avastin) Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL),renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function Patients must be able to understand the nature of this study Written informed consent Exclusion Criteria: History of serious cardiac disease (unstable angina, congestive heart failure, uncontrolled cardiac arrhythmias). History of myocardial infarction or stroke within 6 months. Clinically significant peripheral vascular disease. History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0. Presence of central nervous system or brain mets. Evidence of bleeding diathesis or coagulopathy. Patients with known hypersensitive reaction to cetuximab Blood pressure > 150/100 mmHg. Pregnant or lactating woman. Life expectancy < 3 months. Previous radiotherapy within the last 4 weeks or > 25% of bone marrow. Metastatic infiltration of the liver >50%. Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy. Active infection requiring antibiotics on Day 1. Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer. Psychiatric illness or social situation that would preclude study compliance.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Souglakos, MD

Organizational Affiliation

University Hospital of Crete

Official's Role

Principal Investigator

Facility Information:

Facility Name

University General Hospital of Alexandroupolis, Dep of Medical Oncology

City

Alexandroupolis

Country

Greece

Facility Name

401 Military Hospital of Athens

City

Athens

Country

Greece

Facility Name

: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

City

Athens

Country

Greece

Facility Name

Air Forces Military Hospital of Athens

City

Athens

Country

Greece

Facility Name

IASO" General Hospital of Athens, 1st Dep of Medical Oncology

City

Athens

Country

Greece

Facility Name

State General Hospital of Larissa

City

Larissa

Country

Greece

Facility Name

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

City

Piraeus

Country

Greece

Facility Name

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

City

Thessaloniki

Country

Greece

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer

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